Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Completed · Phase 2/Phase 3

Conditions studied: Acute Otitis Media

In brief

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.

Key facts

Study ID

NCT00645203

Run by

Abbott

People needed

447

Starts

2002-07-01

Last updated by the study team

2008-03-27

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female children between 6 months and 4 years of age
• Weight does not exceed 40 kg
• Clinical diagnosis is acute otitis media
• Have evidence of middle ear fluid
• At risk for persistent or recurrent otitis media
• Generally in good health

You may not qualify if…

• Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications
• Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear
• Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study
• Concomitant infection, that requires additional antimicrobial therapy
• Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Clovis, California, United States
• Study site — Dinuba, California, United States
• Study site — Folsom, California, United States
• Study site — Denver, Colorado, United States
• Study site — Brooklyn, New York, United States
• Study site — Rochester, New York, United States
• Study site — Rochester, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Erie, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Providencia, Santiago Metropolitan, Chile
• Study site — Puente Alto, Santiago, Chile
• Study site — Uruca, Provincia de San José, Costa Rica
• Study site — San José, Costa Rica
• Study site — Santo Domingo, Dominican Republic
• Study site — Guatemala City, Guatemala
• Study site — Guatemala City, Guatemala
• Study site — Beersheba, Israel
• Study site — Panama City, Panama

Full record on ClinicalTrials.gov

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