Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Sep 2, 2026, 12:36 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
Oct 31, 2003
Primary completion
Dec 31, 2003
Completion
Not listed
Last update posted
Mar 26, 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 26, 2008 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT00645112 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →