Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections - Study Results

Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections (Meropenem PK)

This study has been completed.

Study NCT00621192 Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

First Received on February 20, 2008. Last Updated on February 9, 2012 History of Changes

Results First Received: October 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Necrotizing Enterocolitis Intra-abdominal Infection
Intervention:	Drug: meropenem

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment Period - June 19, 2008 to October 6, 2009 Locations - Hospitals including University Hospitals Total number of sites - 24 Total number of participants - 200

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Other antimicrobials in addition to meropenem was used in the study due to concerns regarding the safety and ethics of using monotherapy in this patient population.The study was designed as an open-label, dose escalation study because sufficient data regarding the feasibility of a randomized, active controlled efficacy study was unavailable.

Reporting Groups

	Description
1. GA <32 Wks; PNA<2 Wks	Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
2. GA <32 Wks; PNA 91days ≥ 2Wks	Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
3. GA ≥ 32 Wks; PNA <2 Wks	Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks	Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.

Participant Flow: Overall Study

	1. GA <32 Wks; PNA<2 Wks	2. GA <32 Wks; PNA 91days ≥ 2Wks	3. GA ≥ 32 Wks; PNA <2 Wks	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks
STARTED	39	103	31	27
Safety Population	39	103	31	27
Efficacy Population	39	101	28	27
COMPLETED	35	94	26	24
NOT COMPLETED	4	9	5	3
Withdrawal by Subject	0	0	2	0
Physician Decision	1	3	0	0
Protocol Violation	1	0	0	1
Adverse Event	0	1	0	1
Death	2	5	0	0
Final Assessments not Completed	0	0	3	1

Baseline Characteristics

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Reporting Groups

	Description
1. GA <32 Wks; PNA<2 Wks	Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
2. GA <32 Wks; PNA 91days ≥ 2Wks	Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
3. GA ≥ 32 Wks; PNA <2 Wks	Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks	Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.

Baseline Measures

	1. GA <32 Wks; PNA<2 Wks	2. GA <32 Wks; PNA 91days ≥ 2Wks	3. GA ≥ 32 Wks; PNA <2 Wks	4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks	Total
Number of Participants [units: participants]	39	103	31	27	200
Age ^[1] [units: Days] Mean ± Standard Deviation
Mean Postnatal Age	8.5 ± 3.3	38.3 ± 19.3	6.5 ± 3.5	36.0 ± 22.0	27.3 ± 21.6
Gender [units: Participants]
Female	15	47	9	11	82
Male	24	56	22	16	118
Ethnicity (NIH/OMB) [units: participants]
Hispanic or Latino	5	16	4	3	28
Not Hispanic or Latino	32	81	27	24	164
Unknown or Not Reported	2	6	0	0	8
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	0	0	0	0	0
Asian	0	1	0	1	2
Native Hawaiian or Other Pacific Islander	1	0	1	0	2
Black or African American	12	33	8	5	58
White	25	65	21	18	129
More than one race	1	2	0	2	5
Unknown or Not Reported	0	2	1	1	4

[1]	Post Natal Age

Outcome Measures

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1. Primary:

Efficacy Success (Alive at Efficacy Visit,Last Culture (if Obtained) From Sterile Body Fluid is Negative for Bacteria (Except Staphylococcus Species) From Start of Study Drug Until Efficacy Visit,Presumptive Clinical Cure Score(PCCS) >7 at Efficacy Visit) [ Time Frame: Average of 12 days (3 to 21 days) ]

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2. Primary:

Deaths [ Time Frame: Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug) ]

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3. Primary:

Meropenem Clearance [ Time Frame: 24 hours prior, post 1hr, post 4hrs, post 7-8hrs. ]

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4. Primary:

Key Safety Endpoints [ Time Frame: Up to 51 days (AEs were recorded from the time of informed consent until 72 hours following the last dose of study drug) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Siegel, MD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development
phone: 301-595-8670
e-mail: siegelda@mail.nih.gov

No publications provided

Responsible Party:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00621192 History of Changes
Other Study ID Numbers:	HHSN267200700051C, HHSN267200700051C
Study First Received:	February 20, 2008
Results First Received:	October 20, 2011
Last Updated:	February 9, 2012
Health Authority:	United States: Food and Drug Administration