Trial · NCT00643292
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
NCT00643292, Phase 3, Completed, Pfizer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections. Trials, record NCT00643292. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00643292
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
- NCT number
- NCT00643292
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 902 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Acute Otitis Media
- Interventions
- amoxicillin/clavulanate postassium (Augmentin ES-600), azithromycin SR
- First posted
- 2008-03-26
- Last updated
- 2011-05-17
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | clinical response (cure or failure) in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 12-14) | |
| Secondary | summary of baseline susceptibilities | Study endpoint | |
| Secondary | clinical response (cure or failure) in the Clinical Per Protocol population | On-Treatment (OT) visit (Day 4-6) | |
| Secondary | Laboratory abnormalities | Baseline and TOC visit | |
| Secondary | bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population | TOC visit | |
| Secondary | adverse events | Continuous | |
| Secondary | clinical response (cure or failure) in all populations except the Clinical Per Protocol population | OT visit and TOC visit | |
| Secondary | clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population | OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32) | |
| Secondary | clinical response (cure or failure) in the Clinical Per Protocol population | LTFU visit | |
| Secondary | clinical scores for the Clinical Per Protocol population | OT visit and TOC visit |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00643292
GET https://conductscience.org/api/trials/v1/NCT00643292/registered