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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: Completed Phase 1 study of Necrotizing Enterocolitis and Intra-abdominal Infection, sponsored by The Emmes Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 m
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 |
What the finished NCT00621192 record still lists
NCT00621192 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 299-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (33% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT00621192's enrollment target sits among peer trials
200 6th of 14 higher than 8 of 14 other Necrotizing Enterocolitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Necrotizing Enterocolitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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