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NCT00377260 · ClinicalTrials.gov registry record · Phase 4
Acute Otitis Media (AOM) Therapy Trial in Young Children
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 291
- Enrollment target
NCT00377260 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 291 participants.
The verdict
NCT00377260, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 291 participants
- Enrollment target
Study Summary
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children with AOM. About 268 children in Pittsburgh, between the ages of 6-23 months, with AOM will be enrolled in the study. They will be treated either with Augmentin (an antibiotic) or placebo for 10 days and closely followed for about 1 month. Parents will be asked to write information about their child in a Patient Diary. A general physical exam, including an ear exam, will be performed 4 times during the study. A mucus sample will be collected from the back of each child's nose. Parents will be asked questions during phone calls and at every visit. If a child has not improved or has worsened, the investigators will prescribe a different antibiotic that is known to kill resistant germs.
Interventions
- DRUG Placebo
- DRUG amoxicillin-clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00377260
The ClinicalTrials.gov registry entry for NCT00377260 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 291 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00377260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00377260 about?
NCT00377260 is a clinical study titled "Acute Otitis Media (AOM) Therapy Trial in Young Children". The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics. The study will compare two treatment strategies, "watchful waiting" or treatment with antibiotics, to determine which is more appropriate for children...
What is the current status of trial NCT00377260?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 291 participants. The study started on 2006-11. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00377260?
The interventions under investigation include: Placebo (DRUG), amoxicillin-clavulanate (DRUG).
Who is sponsoring clinical trial NCT00377260?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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