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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00621192
First received: February 20, 2008
Last updated: October 8, 2013
Last verified: August 2013
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

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) ]

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) ]

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

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


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


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 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications automatically indexed to this study:

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: October 8, 2013
Health Authority: United States: Food and Drug Administration