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Antibiotic Safety (SCAMP) (SCAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01994993
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 27, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Complicated Intra Abdominal Infections
Interventions Drug: ampicillin and metronidazole and gentamicin
Drug: ampicillin and gentamicin and clindamycin
Drug: gentamicin and Piperacillin- tazobactam
Drug: standard of care antibiotics and metronidazole
Drug: metronidazole, clindamycin, or piperacillin-tazobactam
Enrollment 260
Recruitment Details  
Pre-assignment Details One participant was enrolled but did not receive any dose of study drug. The participant is excluded from study result data analysis
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

metronidazole, clindamycin, or piperacillin-tazobactam

metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Period Title: Overall Study
Started 63 47 70 55 24
Completed 28 12 23 9 22
Not Completed 35 35 47 46 2
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5 Total
Hide Arm/Group Description

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

metronidazole, clindamycin, or piperacillin-tazobactam

metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Total of all reporting groups
Overall Number of Baseline Participants 62 46 70 55 24 257
Hide Baseline Analysis Population Description
count of participants Note: the overall numbers above were based on "Per protocol population", defined as participants who received at least 1 study dose of each study drug of the enrolled treatment group.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Gestational Age (weeks)
Number Analyzed 62 participants 46 participants 70 participants 55 participants 24 participants 257 participants
27.3  (2.6) 27.8  (3.0) 27.5  (2.9) 36.4  (2.1) 28.9  (4.9) 29.5  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 46 participants 70 participants 55 participants 24 participants 257 participants
Female
18
  29.0%
17
  37.0%
42
  60.0%
27
  49.1%
10
  41.7%
114
  44.4%
Male
44
  71.0%
29
  63.0%
28
  40.0%
28
  50.9%
14
  58.3%
143
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 46 participants 70 participants 55 participants 24 participants 257 participants
Hispanic or Latino
12
  19.4%
11
  23.9%
11
  15.7%
12
  21.8%
1
   4.2%
47
  18.3%
Not Hispanic or Latino
46
  74.2%
34
  73.9%
52
  74.3%
38
  69.1%
20
  83.3%
190
  73.9%
Unknown or Not Reported
4
   6.5%
1
   2.2%
7
  10.0%
5
   9.1%
3
  12.5%
20
   7.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 46 participants 70 participants 55 participants 24 participants 257 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
2
   0.8%
Asian
0
   0.0%
1
   2.2%
1
   1.4%
1
   1.8%
0
   0.0%
3
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  32.3%
10
  21.7%
23
  32.9%
8
  14.5%
6
  25.0%
67
  26.1%
White
32
  51.6%
26
  56.5%
37
  52.9%
35
  63.6%
14
  58.3%
144
  56.0%
More than one race
2
   3.2%
1
   2.2%
4
   5.7%
1
   1.8%
2
   8.3%
10
   3.9%
Unknown or Not Reported
7
  11.3%
8
  17.4%
5
   7.1%
9
  16.4%
2
   8.3%
31
  12.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Count of participants
Number Analyzed 62 participants 46 participants 70 participants 55 participants 24 participants 257 participants
Canada 4 0 0 0 1 5
United States 58 46 70 55 23 252
1.Primary Outcome
Title Death
Hide Description Number of Participants who experienced Death
Time Frame Within 30 days after last dose of study drug, up to 40 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full intent-to-treat population (patients who received at least 1 dose of any study drug)
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

metronidazole, clindamycin, or piperacillin-tazobactam

metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 63 47 70 56 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
   7.9%
5
  10.6%
7
  10.0%
1
   1.8%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Therapeutic Success at Day 30
Hide Description

Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.

Clinical cure score =1 for each of the following elements:

FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment

Time Frame 30 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of each study drug. Does not apply to Group 5.
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
45
  72.6%
39
  84.8%
52
  74.3%
52
  94.5%
3.Other Pre-specified Outcome
Title Number of Participants With Feeding Intolerance
Hide Description Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed
Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
24
  38.7%
19
  41.3%
21
  30.0%
18
  32.7%
4.Other Pre-specified Outcome
Title Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)
Hide Description

Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement

Grade 4 IVH: Intraparenchymal hemorrhage

Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.2%
4
   8.7%
4
   5.7%
0
   0.0%
5.Other Pre-specified Outcome
Title Number of Participants With Short Bowel Syndrome
Hide Description

Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.

Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age

Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
5
   8.1%
3
   6.5%
1
   1.4%
1
   1.8%
6.Other Pre-specified Outcome
Title Number of Participants With Intestinal Perforation
Hide Description

Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.

Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement

Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.2%
4
   8.7%
2
   2.9%
1
   1.8%
7.Other Pre-specified Outcome
Title Number of Participants With Intestinal Stricture
Hide Description

Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.

Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement

Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.8%
2
   4.3%
4
   5.7%
1
   1.8%
8.Other Pre-specified Outcome
Title Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection
Hide Description Progression is determined by the clinical NEC scoring
Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.6%
2
   4.3%
0
   0.0%
1
   1.8%
9.Other Pre-specified Outcome
Title Number of Participants With Gastrointestinal Surgeries
Hide Description Determined by medical history and confirmed with hospital records. (Laparotomy)
Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
27
  43.5%
15
  32.6%
26
  37.1%
10
  18.2%
10.Other Pre-specified Outcome
Title Number of Participants With Seizure
Hide Description documented seizure(s) in hospital records
Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
4
   6.5%
0
   0.0%
2
   2.9%
1
   1.8%
11.Other Pre-specified Outcome
Title Number of Participants With Positive Blood Cultures
Hide Description Positive blood culture (bacterial or fungal)
Time Frame 90 days after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Participant who received at least 1 dose of each study drug
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description:

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Overall Number of Participants Analyzed 62 46 70 55
Measure Type: Count of Participants
Unit of Measure: Participants
8
  12.9%
4
   8.7%
12
  17.1%
5
   9.1%
Time Frame 90 days post last study dose
Adverse Event Reporting Description Note: Participants who received at least 1 dose of any study drug in the randomized or assigned protocol treatment group were included in the intention-to-treat (ITT) population used for the safety and efficacy analyses
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description

Ampicillin and gentamycin and metronidazole

ampicillin and metronidazole and gentamicin: IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

ampicillin and gentamicin and clindamycin

ampicillin and gentamicin and clindamycin: IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

piperacillin-tazobactam and gentamicin

gentamicin and Piperacillin- tazobactam: IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

Per standard of care antibiotics, and Metronidazole

standard of care antibiotics and metronidazole: IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

metronidazole, clindamycin, or piperacillin-tazobactam

metronidazole, clindamycin, or piperacillin-tazobactam: IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)

All-Cause Mortality
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/62 (8.06%)      5/46 (10.87%)      7/70 (10.00%)      1/55 (1.82%)      0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/62 (30.65%)      10/46 (21.74%)      12/70 (17.14%)      3/55 (5.45%)      3/24 (12.50%)    
Cardiac disorders           
Cardiac arrest   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Cardiopulmonary failure   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 1/55 (1.82%)  1 0/24 (0.00%)  0
Congenital, familial and genetic disorders           
Patent ductus arteriosus   1/62 (1.61%)  1 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Eye disorders           
Retinal detachment   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 1/55 (1.82%)  1 0/24 (0.00%)  0
Retinopathy of prematurity   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Gastrointestinal disorders           
Gastrointestinal necrosis   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Necrotising colitis   1/62 (1.61%)  1 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Oesophageal perforation   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
General disorders           
Organ failure   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Infections and infestations           
Bacterial sepsis   1/62 (1.61%)  1 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Candida infection   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Candida sepsis   1/62 (1.61%)  1 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Cytomegalovirus infection   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Enterococcal sepsis   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Escherichia infection   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Escherichia sepsis   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Fungal endocarditis   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Fungal infection   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Pneumonia   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Pseudomonal bacteraemia   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Pseudomonal sepsis   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Sepsis   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Septic shock   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Staphylococcal sepsis   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications           
Endotracheal intubation complication   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders           
Encephalopathy   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Haemorrhage intracranial   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Hydrocephalus   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Infantile apnoea   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 1/55 (1.82%)  1 0/24 (0.00%)  0
Neonatal respiratory failure   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Pleural effusion   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 1/24 (4.17%)  1
Pneumothorax   1/62 (1.61%)  1 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Respiratory distress   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Respiratory failure   0/62 (0.00%)  0 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 1/24 (4.17%)  1
Surgical and medical procedures           
Debridement   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 1/24 (4.17%)  1
Patent ductus arteriosus repair   1/62 (1.61%)  1 1/46 (2.17%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Vascular disorders           
Extremity necrosis   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Hypotension   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Shock haemorrhagic   1/62 (1.61%)  1 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 0/24 (0.00%)  0
Venous occlusion   0/62 (0.00%)  0 0/46 (0.00%)  0 1/70 (1.43%)  1 0/55 (0.00%)  0 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/62 (16.13%)      6/46 (13.04%)      10/70 (14.29%)      4/55 (7.27%)      9/24 (37.50%)    
Blood and lymphatic system disorders           
Thrombocytopenia   4/62 (6.45%)  5 3/46 (6.52%)  3 4/70 (5.71%)  4 0/55 (0.00%)  0 1/24 (4.17%)  1
Anaemia   3/62 (4.84%)  7 0/46 (0.00%)  0 1/70 (1.43%)  1 3/55 (5.45%)  3 0/24 (0.00%)  0
Hepatobiliary disorders           
Jaundice cholestatic   1/62 (1.61%)  1 0/46 (0.00%)  0 4/70 (5.71%)  4 0/55 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders           
Intraventricular haemorrhage neonatal   0/62 (0.00%)  0 2/46 (4.35%)  2 0/70 (0.00%)  0 0/55 (0.00%)  0 2/24 (8.33%)  2
Psychiatric disorders           
Agitation   0/62 (0.00%)  0 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 2/24 (8.33%)  2
Respiratory, thoracic and mediastinal disorders           
Respiratory failure   0/62 (0.00%)  0 1/46 (2.17%)  1 1/70 (1.43%)  1 1/55 (1.82%)  1 2/24 (8.33%)  2
Skin and subcutaneous tissue disorders           
Skin disorder   2/62 (3.23%)  2 0/46 (0.00%)  0 0/70 (0.00%)  0 0/55 (0.00%)  0 2/24 (8.33%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Cohen-Wolkowiez, M.D
Organization: Duke University Medical Center
Phone: 9196688812
EMail: michael.cohenwolkowiez@duke.edu
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Responsible Party: Michael Cohen-Wolkowiez, Duke University
ClinicalTrials.gov Identifier: NCT01994993     History of Changes
Other Study ID Numbers: Pro00048773
HHSN275201000003I ( Other Grant/Funding Number: NICHD )
First Submitted: November 18, 2013
First Posted: November 26, 2013
Results First Submitted: January 15, 2018
Results First Posted: February 27, 2018
Last Update Posted: May 30, 2019