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Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults

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ClinicalTrials.gov Identifier: NCT02168946
Recruitment Status : Completed
First Posted : June 20, 2014
Results First Posted : December 11, 2018
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Melinta Therapeutics, Inc. ( Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Urinary Tract Infection Complicated
Acute Pyelonephritis
Hospital Acquired Bacterial Pneumonia
Ventilator-associated Bacterial Pneumonia
Bacteremia
Abdominal Infection
Interventions Drug: Vabomere
Drug: Best Available Therapy
Enrollment 77
Recruitment Details The first patient enrolled November 2014 and last patient in June 2017. The patients were enrolled at 27 study sites in 8 countries. 77 patients (28 with bacteremia, 34 with cUTI, 8 with HABP/VABP and 7 with cIAI) were enrolled and 47 had confirmed Carbapenem-Resistant Enterobacteriaceae and therefore were included in the mCRE population.
Pre-assignment Details Randomization was stratified by presenting indication (cUTI or AP, cIAI, HABP, VABP, or bacteremia) and by region (North America, Europe, Asia Pacific, and Rest of World).
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description

Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days

Vabomere: Vabomere for IV injection, administered as a 2 g/2 g dose

Subjects will receive Best Available Therapy (IV antibiotics)

Best Available Therapy: Antibiotic(s) chosen by Investigator

Period Title: Overall Study
Started 50 [1] 25
Completed 38 20
Not Completed 12 5
Reason Not Completed
Adverse Event             8             5
Lost to Follow-up             3             0
Subject unable to come back for visits             1             0
[1]
2 additional subjects were randomized to Vabomere but did not receive study drug
Arm/Group Title Vabomere Best Available Therapy Total
Hide Arm/Group Description Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days Best Available Therapy: Antibiotic(s) chosen by Investigator Total of all reporting groups
Overall Number of Baseline Participants 50 25 75
Hide Baseline Analysis Population Description
All randomized subjects who received at least one dose of study drug (MITT and Safety Population)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  52.0%
14
  56.0%
40
  53.3%
>=65 years
24
  48.0%
11
  44.0%
35
  46.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 25 participants 75 participants
63.6  (15.30) 63.2  (13.10) 63.5  (14.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
Female
25
  50.0%
7
  28.0%
32
  42.7%
Male
25
  50.0%
18
  72.0%
43
  57.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
Hispanic or Latino
9
  18.0%
5
  20.0%
14
  18.7%
Not Hispanic or Latino
41
  82.0%
20
  80.0%
61
  81.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.0%
1
   4.0%
2
   2.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.0%
2
   8.0%
5
   6.7%
White
43
  86.0%
22
  88.0%
65
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   6.0%
0
   0.0%
3
   4.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 50 participants 25 participants 75 participants
27.90  (8.340) 27.14  (7.522) 27.64  (8.029)
Systemic Inflammatory Response Syndrome (SIRS) present   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
22
  44.0%
10
  40.0%
32
  42.7%
[1]
Measure Description: SIRS is a serious condition related to systemic inflammation, organ dysfunction, and organ failure.
Creatinine Clearance <50 mL/min  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
12
  24.0%
9
  36.0%
21
  28.0%
Baseline Pathogen - Klebsiella pneumoniae  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 25 participants 75 participants
30
  60.0%
14
  56.0%
44
  58.7%
1.Primary Outcome
Title Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects]
Hide Description Overall success is defined as clinical cure & microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at Test of Cure (TOC) visit (Day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
The mCRE-MITT population includes all patients who had confirmed Carbapenem-Resistant Enterobacteriaceae at Baseline. (cUTI/AP patients only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
  33.3%
2
  50.0%
2.Primary Outcome
Title All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)
Hide Description The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT Population (HABP/VABP and Bacteremia subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
4
  22.2%
4
  44.4%
3.Primary Outcome
Title Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
Time Frame at TOC visit (Day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
0
   0.0%
4.Secondary Outcome
Title The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)
Hide Description All Cause Mortality at Day 28 in the mCRE-MITT population (all indications)
Time Frame at Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT population (all indications)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 32 15
Measure Type: Count of Participants
Unit of Measure: Participants
5
  15.6%
5
  33.3%
5.Secondary Outcome
Title The All-cause Mortality Rate in the m-MITT Population (All Indications)
Hide Description The All Cause Mortality rate at Day 28 in the m-MITT population (all indications)
Time Frame at Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The m-MITT population includes all patients who receive at least one dose of study drug and have a baseline gram negative bacterial pathogen.
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 35 19
Measure Type: Count of Participants
Unit of Measure: Participants
5
  14.3%
5
  26.3%
6.Secondary Outcome
Title The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)
Hide Description All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only)
Time Frame at Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT (cUTI/AP subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
0
   0.0%
7.Secondary Outcome
Title Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days)
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT population (all indications)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 32 15
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
21
  65.6%
5
  33.3%
TOC
19
  59.4%
4
  26.7%
8.Secondary Outcome
Title Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT population (cUTI/AP subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 12 4
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
9
  75.0%
2
  50.0%
TOC
5
  41.7%
2
  50.0%
9.Secondary Outcome
Title Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT (HABP/VABP or Bacteremia Subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 18 9
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
10
  55.6%
3
  33.3%
TOC
12
  66.7%
2
  22.2%
10.Secondary Outcome
Title Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (all indications)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 35 19
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
24
  68.6%
7
  36.8%
TOC
21
  60.0%
6
  31.6%
11.Secondary Outcome
Title Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (cUTI/AP subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 13 8
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
10
  76.9%
4
  50.0%
TOC
6
  46.2%
4
  50.0%
12.Secondary Outcome
Title Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)
Hide Description Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (HABP/VABP or Bacteremia Subjects only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 20 9
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
12
  60.0%
3
  33.3%
TOC
13
  65.0%
2
  22.2%
13.Secondary Outcome
Title Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)
Hide Description Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA).
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
mCRE-MITT Population (all indications)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 32 15
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
21
  65.6%
6
  40.0%
TOC
17
  53.1%
5
  33.3%
14.Secondary Outcome
Title Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)
Hide Description Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA).
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (all indications)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 35 19
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
23
  65.7%
8
  42.1%
TOC
17
  48.6%
7
  36.8%
15.Secondary Outcome
Title Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)
Hide Description Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (cUTI/AP Subjects Only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 13 8
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
10
  76.9%
4
  50.0%
TOC
4
  30.8%
4
  50.0%
16.Secondary Outcome
Title Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)
Hide Description Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.
Time Frame at EOT visit (7-14) and TOC visit (day 12-23)
Hide Outcome Measure Data
Hide Analysis Population Description
m-MITT Population (Bacteremia Subjects Only)
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description:
Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days
Best Available Therapy: Antibiotic(s) chosen by Investigator
Overall Number of Participants Analyzed 15 8
Measure Type: Count of Participants
Unit of Measure: Participants
EOT
8
  53.3%
3
  37.5%
TOC
8
  53.3%
2
  25.0%
Time Frame Day 1 Through the Late Follow-Up Visit (LFU)- LFU defined as 14 days (+ or - 2 days) after the EOT Visit (7-14 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vabomere Best Available Therapy
Hide Arm/Group Description Vabomere (meropenem 2g plus vaborbactam 2g) IV q8h, for up to 14 days Best Available Therapy: Antibiotic(s) chosen by Investigator
All-Cause Mortality
Vabomere Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   10/50 (20.00%)   6/25 (24.00%) 
Hide Serious Adverse Events
Vabomere Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   17/50 (34.00%)   11/25 (44.00%) 
Blood and lymphatic system disorders     
Anemia * 1  0/50 (0.00%)  1/25 (4.00%) 
Cardiac disorders     
Cardiac Arrest * 1  2/50 (4.00%)  0/25 (0.00%) 
Cardiac Failure Congestive * 1  0/50 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Gastrointestinal Hemorrhage * 1  1/50 (2.00%)  0/25 (0.00%) 
General disorders     
General Physical Health Deterioration * 1  2/50 (4.00%)  0/25 (0.00%) 
Multi-organ Failure * 1  1/50 (2.00%)  0/25 (0.00%) 
Infections and infestations     
Clostridium difficile colitis * 1  0/50 (0.00%)  1/25 (4.00%) 
Enterococcal bacteremia * 1  1/50 (2.00%)  0/25 (0.00%) 
Gangrene * 1  1/50 (2.00%)  0/25 (0.00%) 
Klebsiella Bacteremia * 1  1/50 (2.00%)  0/25 (0.00%) 
Peritonitis * 1  0/50 (0.00%)  1/25 (4.00%) 
Sepsis * 1  2/50 (4.00%)  4/25 (16.00%) 
Septic Shock * 1  1/50 (2.00%)  4/25 (16.00%) 
Superinfection Bacterial * 1  1/50 (2.00%)  0/25 (0.00%) 
Urosepsis * 1  1/50 (2.00%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Glioblastoma * 1  1/50 (2.00%)  0/25 (0.00%) 
Nervous system disorders     
Cerebral Hemorrhage * 1  0/50 (0.00%)  1/25 (4.00%) 
Convulsion * 1  0/50 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Renal Failure Acute * 1  0/50 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia Aspiration * 1  1/50 (2.00%)  0/25 (0.00%) 
Pulmonary Embolism * 1  1/50 (2.00%)  0/25 (0.00%) 
Pulmonary Edema * 1  1/50 (2.00%)  0/25 (0.00%) 
Vascular disorders     
Arterial Hemorrhage * 1  1/50 (2.00%)  0/25 (0.00%) 
Hypotension * 1  0/50 (0.00%)  1/25 (4.00%) 
Shock Hemorrhagic * 1  1/50 (2.00%)  0/25 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Vabomere Best Available Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   28/50 (56.00%)   20/25 (80.00%) 
Blood and lymphatic system disorders     
Anemia * 1  5/50 (10.00%)  2/25 (8.00%) 
Thrombocytopenia * 1  2/50 (4.00%)  2/25 (8.00%) 
Leukopenia * 1  2/50 (4.00%)  1/25 (4.00%) 
Leukocytosis * 1  1/50 (2.00%)  1/25 (4.00%) 
Sickle Cell Anemia with Crisis * 1  0/50 (0.00%)  1/25 (4.00%) 
Cardiac disorders     
Atrial Fibrillation * 1  1/50 (2.00%)  1/25 (4.00%) 
Extrasystoles * 1  1/50 (2.00%)  1/25 (4.00%) 
Tachycardia * 1  1/50 (2.00%)  1/25 (4.00%) 
Endocrine disorders     
Adrenal Insufficiency * 1  0/50 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Diarrhea * 1  6/50 (12.00%)  4/25 (16.00%) 
Nausea * 1  2/50 (4.00%)  2/25 (8.00%) 
Vomiting * 1  4/50 (8.00%)  0/25 (0.00%) 
Abdominal Pain Upper * 1  1/50 (2.00%)  2/25 (8.00%) 
Constipation * 1  2/50 (4.00%)  1/25 (4.00%) 
Abdominal Distension * 1  2/50 (4.00%)  0/25 (0.00%) 
Abdominal Pain * 1  2/50 (4.00%)  0/25 (0.00%) 
Melaena * 1  2/50 (4.00%)  0/25 (0.00%) 
Rectal Hemorrhage * 1  2/50 (4.00%)  0/25 (0.00%) 
Stomatitis * 1  1/50 (2.00%)  1/25 (4.00%) 
Ascites * 1  0/50 (0.00%)  1/25 (4.00%) 
Paraesthesia Oral * 1  0/50 (0.00%)  1/25 (4.00%) 
Salivary Hypersecretion * 1  0/50 (0.00%)  1/25 (4.00%) 
General disorders     
Asthenia * 1  0/50 (0.00%)  2/25 (8.00%) 
Generalized Edema * 1  1/50 (2.00%)  1/25 (4.00%) 
Hypothermia * 1  2/50 (4.00%)  0/25 (0.00%) 
Infusion Site Phlebitis * 1  1/50 (2.00%)  1/25 (4.00%) 
Edema Peripheral * 1  0/50 (0.00%)  2/25 (8.00%) 
Pain * 1  1/50 (2.00%)  1/25 (4.00%) 
Malaise * 1  0/50 (0.00%)  1/25 (4.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  2/50 (4.00%)  0/25 (0.00%) 
Infections and infestations     
Oral Candidiasis * 1  2/50 (4.00%)  1/25 (4.00%) 
Systemic Candida * 1  3/50 (6.00%)  0/25 (0.00%) 
Candiduria * 1  1/50 (2.00%)  1/25 (4.00%) 
Clostridium Difficile Colitis * 1  1/50 (2.00%)  1/25 (4.00%) 
Bacteremia * 1  0/50 (0.00%)  1/25 (4.00%) 
Perinephric Abscess * 1  0/50 (0.00%)  1/25 (4.00%) 
Pseudomonal Bacteremia * 1  0/50 (0.00%)  1/25 (4.00%) 
Sepsis * 1  0/50 (0.00%)  1/25 (4.00%) 
Urinary Tract Infection * 1  0/50 (0.00%)  1/25 (4.00%) 
Urinary Tract Infection Enterococcal * 1  0/50 (0.00%)  1/25 (4.00%) 
Injury, poisoning and procedural complications     
Wound * 1  1/50 (2.00%)  1/25 (4.00%) 
Incision Site Pain * 1  0/50 (0.00%)  1/25 (4.00%) 
Investigations     
Blood Alkaline Phosphatase Increased * 1  1/50 (2.00%)  1/25 (4.00%) 
Transaminases Increased * 1  0/50 (0.00%)  2/25 (8.00%) 
Urine Output Decreased * 1  2/50 (4.00%)  0/25 (0.00%) 
Alanine Aminotransferase Increased * 1  0/50 (0.00%)  1/25 (4.00%) 
Blood Bilirubin Increased * 1  0/50 (0.00%)  1/25 (4.00%) 
Blood Fibrinogen Decreased * 1  0/50 (0.00%)  1/25 (4.00%) 
Blood Urea Increased * 1  0/50 (0.00%)  1/25 (4.00%) 
Electrocardiogram QT Prolonged * 1  0/50 (0.00%)  1/25 (4.00%) 
Metabolism and nutrition disorders     
Hypokalemia * 1  5/50 (10.00%)  2/25 (8.00%) 
Hypoglycemia * 1  4/50 (8.00%)  0/25 (0.00%) 
Hypomagnesemia * 1  3/50 (6.00%)  1/25 (4.00%) 
Hypocalcemia * 1  0/50 (0.00%)  1/25 (4.00%) 
Malnutrition * 1  0/50 (0.00%)  1/25 (4.00%) 
Metabolic Acidosis * 1  0/50 (0.00%)  1/25 (4.00%) 
Type 2 Diabetes Mellitus * 1  0/50 (0.00%)  1/25 (4.00%) 
Vitamin B Complex Deficiency * 1  0/50 (0.00%)  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain * 1  2/50 (4.00%)  0/25 (0.00%) 
Myalgia * 1  2/50 (4.00%)  0/25 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lipoma * 1  0/50 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Tremor * 1  3/50 (6.00%)  1/25 (4.00%) 
Headache * 1  2/50 (4.00%)  0/25 (0.00%) 
Dizziness * 1  0/50 (0.00%)  1/25 (4.00%) 
Parasthesia * 1  0/50 (0.00%)  1/25 (4.00%) 
Somnolence * 1  0/50 (0.00%)  1/25 (4.00%) 
Psychiatric disorders     
Confusional State * 1  0/50 (0.00%)  2/25 (8.00%) 
Restlessness * 1  0/50 (0.00%)  2/25 (8.00%) 
Delirium * 1  0/50 (0.00%)  1/25 (4.00%) 
Disorientation * 1  0/50 (0.00%)  1/25 (4.00%) 
Hallucination * 1  0/50 (0.00%)  1/25 (4.00%) 
Renal and urinary disorders     
Renal Failure Acute * 1  1/50 (2.00%)  3/25 (12.00%) 
Renal Impairment * 1  1/50 (2.00%)  2/25 (8.00%) 
Hematuria * 1  1/50 (2.00%)  1/25 (4.00%) 
Renal Failure * 1  0/50 (0.00%)  1/25 (4.00%) 
Reproductive system and breast disorders     
Penile Hemorrhage * 1  0/50 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  2/50 (4.00%)  1/25 (4.00%) 
Pleural Effusion * 1  0/50 (0.00%)  1/25 (4.00%) 
Pneumothorax * 1  0/50 (0.00%)  1/25 (4.00%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  1/50 (2.00%)  1/25 (4.00%) 
Rash Macular * 1  0/50 (0.00%)  1/25 (4.00%) 
Skin Exfoliation * 1  0/50 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Hypotension * 1  4/50 (8.00%)  3/25 (12.00%) 
Hypertension * 1  2/50 (4.00%)  0/25 (0.00%) 
Embolism * 1  0/50 (0.00%)  1/25 (4.00%) 
Extremity Necrosis * 1  0/50 (0.00%)  1/25 (4.00%) 
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
Enrollment Challenges required the Sponsor to terminate the study early which led to a smaller number of patients being enrolled.
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: Global Health Science Center
Organization: Rempex Pharmaceuticals, A Wholly Owned Subsidiary of Melinta Therapeutics, Inc.
Phone: 1-844-633-6568
EMail: medinfo@melinta.com
Layout table for additonal information
Responsible Party: Melinta Therapeutics, Inc. ( Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.) )
ClinicalTrials.gov Identifier: NCT02168946    
Other Study ID Numbers: Rempex 506
First Submitted: June 18, 2014
First Posted: June 20, 2014
Results First Submitted: September 27, 2018
Results First Posted: December 11, 2018
Last Update Posted: March 4, 2019