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NCT00621192 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Necrotizing Enterocolitis and Intra-abdominal Infection, sponsored by The Emmes Company.

Completed
Registry status
Phase 1
Development phase
200
Enrollment target
20
Study locations

NCT00621192 is a Phase 1 study of Necrotizing Enterocolitis and Intra-abdominal Infection that has completed, run by The Emmes Company. The registered enrollment target is 200 participants, below the 299-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT00621192, a Phase 1 study of Necrotizing Enterocolitis and Intra-abdominal Infection, has completed, sponsored by The Emmes Company.

COMPLETED
Registry status
Phase 1
Development phase
200 participants
Enrollment target
20
Study locations

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

Necrotizing Enterocolitis Intra-abdominal Infection

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

FieldValue
Enrollment Target 200 participants
Start Date 2008-06
Est. Completion 2009-10
Phase Phase 1

Sponsor

The Emmes Company

11 total trials

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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, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 299-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (33% lower). The listed sponsor is The Emmes Company, which has 11 total studies on file at ClinicalTrials.gov.

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.

NCT00621192 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, North Carolina.

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.

What interventions are being tested in trial NCT00621192?

The interventions under investigation include: meropenem (DRUG).

Who is sponsoring clinical trial NCT00621192?

This trial is sponsored by The Emmes Company, which has 11 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.