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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00621192 |
Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.
Condition | Intervention | Phase |
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Necrotizing Enterocolitis Intra-Abdominal Infection |
Drug: meropenem |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 Days) With Suspected or Complicated Intra-Abdominal Infections |
Estimated Enrollment: | 160 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Low dose meropenem
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Drug: meropenem
Infants <32 weeks: < 2 week PNA: 10mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 12hr >4 weeks PNA: 20mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 20mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 8hr >4 weeks PNA: 30mg/kg q 8hr |
2: Active Comparator
Medium dose meropenem
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Drug: meropenem
If the Low Dose arm is tolerated: MEDIUM DOSE Infants <32 weeks: < 2 week PNA: 20mg/kg q 12hr 2-4 weeks PNA: 20mg/kg q 8hr >4 weeks PNA: 30mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 20mg/kg q 8hr 2-4 weeks PNA: 30mg/kg q 8hr >4 weeks PNA: 40mg/kg q 8hr |
3: Active Comparator
High dose meropenem
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Drug: meropenem
If the Medium dose arm is tolerated: HIGH DOSE Infants <32 weeks: < 2 week PNA: 20mg/kg q 8hr 2-4 weeks PNA: 30mg/kg q 8hr >4 weeks PNA: 40mg/kg q 8hr Infants ≥32 weeks: < 2 weeks PNA: 30mg/kg q 8hr 2-4 weeks PNA: 40mg/kg q 8hr >4 weeks PNA: 50mg/kg q 8hr |
This study will evaluate the safety, tolerability and PK-PD of meropenem in infants <91 days of age with suspected and complicated intra-abdominal infections.
The specific aims of this trial are:
Ages Eligible for Study: | up to 90 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Danny Benjamin, MD, PhD, MPH | (919)-668-8295 | danny.benjamin@duke.edu |
Contact: Katherine Berezny | (919) -668-8453 | katherine.berezny@duke.edu |
Principal Investigator: | Danny Benjamin, MD, PhD, MPH | Duke University |
Responsible Party: | NICHD ( Perdita Taylor-Zapata, NICHD/Project Officer ) |
Study ID Numbers: | HHSN267200700051C, HHSN267200700051C |
Study First Received: | February 20, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00621192 History of Changes |
Health Authority: | United States: Food and Drug Administration |
meropenem infants intra-abdominal infection pharmacokinetics safety |
Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Diseases Meropenem Necrotizing Enterocolitis |
Intestinal Diseases Gastroenteritis Enterocolitis, Necrotizing Enterocolitis |
Communicable Diseases Anti-Infective Agents Gastrointestinal Diseases Infection Intestinal Diseases Enterocolitis Pharmacologic Actions |
Anti-Bacterial Agents Digestive System Diseases Meropenem Therapeutic Uses Enterocolitis, Necrotizing Gastroenteritis |