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

PHASE4CompletedINTERVENTIONAL
Enrollment

357

Participants

Timeline

Start Date

November 30, 2003

Primary Completion Date

January 31, 2004

Conditions
Acute Otitis Media
Interventions
DRUG

cefdinir (Omnicef)

oral suspension, 7 mg/kg every 12 hours for 5 days

DRUG

azithromycin

oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days.

Trial Locations (30)

15241

Pittsburgh

18960

Sellersville

19606

Reading

22180

Vienna

29425

Charleston

30062

Marietta

30087

Stone Mountain

35051

Columbiana

36116

Montgomery

36360

Ozark

37664

Kingsport

40004

Bardstown

40207

Louisville

42303

Owensboro

43205

Columbus

45424

Huber Heights

49008

Kalamazoo

49024

Portage

49083

Richland

49601

Cadillac

52002

Dubuque

53566

Monroe

68178

Omaha

77566

Lake Jackson

84008

West Jordan

84084

West Jordan

84109

Salt Lake City

84121

Salt Lake City

93710

Fresno

93720

Fresno

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abbott

INDUSTRY