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Completed Phase 4 Interventional

A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media

ClinicalTrials.gov ID: NCT00645112

Public ClinicalTrials.gov record NCT00645112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 3:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.

Study identification

NCT ID
NCT00645112
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Abbott
Industry
Enrollment
357 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 6 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2003 (Type not available)
Primary completion
Jan 2004 (Actual)
Completion
Not listed
Last update posted
Mar 27, 2008

Started 2003

United States locations

U.S. sites
30
U.S. states
15
U.S. cities
27
Facility City State ZIP Site status
Not listed Columbiana Alabama 35051 —
Not listed Montgomery Alabama 36116 —
Not listed Ozark Alabama 36360 —
Not listed Fresno California 93710 —
Not listed Fresno California 93720 —
Not listed Marietta Georgia 30062 —
Not listed Stone Mountain Georgia 30087 —
Not listed Dubuque Iowa 52002 —
Not listed Bardstown Kentucky 40004 —
Not listed Louisville Kentucky 40207 —
Not listed Owensboro Kentucky 42303 —
Not listed Cadillac Michigan 49601 —
Not listed Kalamazoo Michigan 49008 —
Not listed Portage Michigan 49024 —
Not listed Richland Michigan 49083 —
Not listed Omaha Nebraska 68178 —
Not listed Columbus Ohio 43205 —
Not listed Huber Heights Ohio 45424 —
Not listed Pittsburgh Pennsylvania 15241 —
Not listed Reading Pennsylvania 19606 —
Not listed Sellersville Pennsylvania 18960 —
Not listed Charleston South Carolina 29425 —
Not listed Kingsport Tennessee 37664 —
Not listed Lake Jackson Texas 77566 —
Not listed Salt Lake City Utah 84109 —
Not listed Salt Lake City Utah 84121 —
Not listed West Jordan Utah 84008 —
Not listed West Jordan Utah 84084 —
Not listed Vienna Virginia 22180 —
Not listed Monroe Wisconsin 53566 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00645112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 27, 2008 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00645112 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →