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Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections
NCT00621192 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG meropenem
Study Locations (20)
California
- Children's Hospital of Oakland — Oakland
- Children's Hospital of Orange County — Orange
- University of California Medical Center — San Diego
- Sharp-Mary Birch Hospital for Women — San Diego
New York
- Albany Medical Center — Albany
- Suny Downstate Medical Center — Brooklyn
North Carolina
- Duke University Medical Center — Durham
- Duke University — Durham
Ohio
- Akron Children's Hospital — Akron
- Case Western Reserve, RB&C, UHCMC — Cleveland
Alabama
- University of Alabama — Birmingham
Connecticut
- Yale New Haven Hospital — New Haven
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- University of Florida — Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00621192
The ClinicalTrials.gov registry entry for NCT00621192 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Emmes Company, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 1 intervention — of which meropenem is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00621192 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00621192 about?
NCT00621192 is a clinical study titled "Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections". 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 inf...
What is the current status of trial NCT00621192?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2008-06. Estimated completion is 2009-10.
What conditions does trial NCT00621192 study?
This clinical trial studies the following conditions: Necrotizing Enterocolitis, Intra-abdominal Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00621192?
The interventions under investigation include: meropenem (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00621192?
This trial is sponsored by The Emmes Company, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00621192 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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