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NCT01222585 · ClinicalTrials.gov registry record · Phase 1
Metronidazole Pharmacokinetics (PK) in Premature Infants
A Phase 1 study, sponsored by Michael Cohen-Wolkowiez.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01222585: Completed Phase 1 study, sponsored by Michael Cohen-Wolkowiez.
NCT01222585 is a Phase 1 study that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222585, a Phase 1 study, has completed, sponsored by Michael Cohen-Wolkowiez.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an antibiotic that is often administered to infants with suspected or confirmed necrotizing enterocolitis. Unfortunately, the appropriate dose of metronidazole in premature infants has not been established and it is likely to be different from older children and adults. The investigators will investigate the appropriate metronidazole dose in very premature infants by: 1) determining how premature infants eliminate metronidazole from the body and 2) determining the safest and most effective dose of metronidazole in premature infants. The investigators hypothesis are: 1) The rate of removal of metronidazole will increase with infant maturity and 2) an appropriate metronidazole dosing regimen will result in necessary drug levels to treat bacteria involved in necrotizing enterocolitis.
Primary Outcome
Area under the curve at steady state (AUCss)
Interventions
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01222585 record still lists
NCT01222585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Metronidazole is the first listed.
NCT01222585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01222585 about?
NCT01222585 is a clinical study titled "Metronidazole Pharmacokinetics (PK) in Premature Infants". Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. ...
What is the current status of trial NCT01222585?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-01. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01222585?
The interventions under investigation include: Metronidazole (DRUG).
Who is sponsoring clinical trial NCT01222585?
This trial is sponsored by Michael Cohen-Wolkowiez, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01222585's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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