Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
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ClinicalTrials.gov Identifier: NCT00621192 |
Recruitment Status
:
Completed
First Posted
: February 22, 2008
Results First Posted
: November 29, 2011
Last Update Posted
: April 17, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Necrotizing Enterocolitis Intra-abdominal Infection | Drug: meropenem | Phase 1 Phase 2 |
This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections.
The specific aims of this trial are:
- To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
- To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
- To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-abdominal Infections |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Meropenem
These Participants were subdivided into the following four groups based on Gestational Age (GA) and Postnatal Age (PNA): Group 1: GA at birth below 32 weeks - PNA <2 weeks; Group 2: GA at birth below 32 weeks - PNA ≥2 weeks and <91 days; Group 3: GA at birth 32 weeks or older - PNA <2 weeks; Group 4: GA at birth 32 weeks or older - PNA ≥2 weeks and <91 days. |
Drug: meropenem
Meropenem was administered concomitantly with compatible medications. Because an in-line filter is not appropriate due to drug binding, the 30 minute infusion was rate controlled by using appropriate infusion (syringe) pumps. Dosing and administration of other antimicrobial therapy (e.g., an aminoglycoside) was administered per local standard of care at the discretion of the infant's neonatologist. If there was a delay in the study drug shipment, sites were to use open-label meropenem to protect the safety of the participant. 20 mg/kg every 12 hours in infants <32 weeks GA and PNA < 2 weeks 20 mg/kg every 8 hours in infants <32 weeks GA and PNA ≥ 2 weeks 20 mg/kg every 8 hours in infants ≥32 weeks GA and PNA < 2 weeks 30 mg/kg every 8 hours in infants ≥32 weeks GA and PNA ≥ 2 weeks Other Name: Merrem
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- 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) ]
The PCCS was derived by comparing clinical signs and symptoms prior to administration of the first dose of study drug and study Day 28.The elements of the PCCS include Mean BP,Temp,PaO2(mmHg)/FiO2,Lowest serum pH,seizures,Urine output,Cardiovascular inotrope support,C-reactive protein (CRP)and Abdominal girth.
Score - Asymptomatic to Asymptomatic 1;Asymptomatic to Worsening 0;Symptomatic to Worsening 0;Symptomatic to No change 0;Symptomatic to Improved 1;Symptomatic to Asymptomatic 1
If 7 or more of 10 signs received a score of 1, then the infant was considered a presumptive clinical cure.
GA stands for Gestational Age and PNA stands for Postnatal Age.
- Deaths [ Time Frame: Up to 51 days (Recorded from the time of informed consent until 72 hours following the last dose of study drug) ]
- Meropenem Clearance [ Time Frame: Up to 7-8hrs post drug administration ]Given the limited availability of blood for Pharmacokinetic (PK) assessments in this population a sparse sampling approach was utilized. Subjects were assigned to one of two Dose 1 sample collection schedules, "PK-odd" and "PK-even" based on birth date to ensure collection of PK data throughout the dose interval. In addition, PK samples were collected around approximately the 5th dose. Subjects that did not have Dose 1 PK samples could have steady-state (Dose 5) using the Dose 5 PK collection schedule.
- 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) ]Safety assessments included death, seizure documentation (including correlation of serum meropenem level and seizures), strictures, perforation, wound dehiscence, short gut, development of extended beta lactamase infection, development of candidiasis, antimicrobial therapy failure

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Ages Eligible for Study: | up to 90 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written permission from parent or legal guardian
- Age younger than 91 days
- Likely to survive beyond the first 48 hours after enrollment
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Sufficient intravascular access (either peripheral or central) to receive study drug.
AND ONE OF THE FOLLOWING
- 1) Physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. These include peritonitis, NEC (Necrotizing Enterocolitis) Grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination.
OR 2) Possible NEC OR 3) Otherwise receiving meropenem per local standard of care
Exclusion criteria:
- Renal dysfunction evidenced by urine output <0.5 mL/hr/kg over the prior 24 hours
- Serum creatinine >1.7 mg/dL
- History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
- Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
- Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621192

United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, California | |
Children's Hospital of Oakland | |
Oakland, California, United States, 94609 | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
University of California Medical Center | |
San Diego, California, United States, 92117 | |
Sharp-Mary Birch Hospital for Women | |
San Diego, California, United States, 92123 | |
United States, Connecticut | |
Yale New Haven Hospital | |
New Haven, Connecticut, United States | |
United States, District of Columbia | |
Children's National Medical Center | |
Washington DC, District of Columbia, United States, 20010 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 | |
United States, Hawaii | |
Kapiolani Medical Center for Women and Children | |
Honolulu, Hawaii, United States, 96826 | |
United States, Illinois | |
Evanston Northwestern Healthcare | |
Evanston, Illinois, United States, 60056 | |
United States, Indiana | |
Indiana University - Riley Hospital for Children | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kentucky | |
University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Kansas City Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 | |
United States, New York | |
Albany Medical Center | |
Albany, New York, United States, 12208 | |
Suny Downstate Medical Center | |
Brooklyn, New York, United States, 11203 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27708 | |
Duke University | |
Durham, North Carolina, United States, 27715 | |
United States, Ohio | |
Akron Children's Hospital | |
Akron, Ohio, United States, 44308 | |
Case Western Reserve, RB&C, UHCMC | |
Cleveland, Ohio, United States, 44106 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Magee Women's Hospital | |
Pittsburg, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Vanderbilt Children's Hospital | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah medical Center | |
Salt lake City, Utah, United States, 84108 |
Principal Investigator: | Danny Benjamin, MD, PhD, MPH | Duke University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( Other Identifier: NICHD ) |
First Posted: | February 22, 2008 Key Record Dates |
Results First Posted: | November 29, 2011 |
Last Update Posted: | April 17, 2015 |
Last Verified: | March 2015 |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
meropenem infants intra-abdominal infection pharmacokinetics safety |
Additional relevant MeSH terms:
Infection Communicable Diseases Enterocolitis Enterocolitis, Necrotizing Intraabdominal Infections Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Meropenem Thienamycins Anti-Bacterial Agents Anti-Infective Agents |