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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 is a Phase 1 study that has completed, run by Michael Cohen-Wolkowiez. The registered enrollment target is 24 participants.
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.
Interventions
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01222585
The ClinicalTrials.gov registry entry for NCT01222585 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Cohen-Wolkowiez, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Metronidazole is the first listed.
NCT01222585 reports 0 study locations.
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.
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