Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media
Intervention: cefdinir (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Abbott
Summary
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.
Clinical Details
Official title: An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Primary outcome: Bacteriological ResponseClinical response Change in the otoscopic findings
Secondary outcome: Physical exam; Vital signs; Use of concomitant medicationsAdverse events assessment Laboratory evaluations
Eligibility
Minimum age: 6 Months.
Maximum age: 4 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Puente Alto, Santiago, Chile
San Jose, Costa Rica
Santo Domingo ZC 02, Dominican Republic
Guatemala City 01011, Guatemala
Guatemala City, Guatemala
Beer Sheva 84101, Israel
Panama 4087, Panama
Scottsdale, Arizona 85258, United States
Clovis, California 93611, United States
Dinuba, California 93618, United States
Folsom, California 95630, United States
Denver, Colorado 80218, United States
Brooklyn, New York 11203, United States
Rochester, New York 14618, United States
Rochester, New York 14620, United States
Chapel Hill, North Carolina 27514, United States
Erie, Pennsylvania 16508, United States
Pittsburgh, Pennsylvania 15213, United States
La Uruca, San Jose, Costa Rica
Providencia, Santiago, Chile
Dallas, Texas 75390-9035, United States
Salt Lake City, Utah 84113, United States
Additional Information
Starting date: July 2002
Last updated: March 20, 2008
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