Clinical trial NCT00645112: A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
Official title: A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Otitis Media
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 357
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis, documented by medical history and physical examination, is AOM I 1 week.
* Clinical symptoms include \>=1 of the following: Otalgia (earache or pain), this may be expressed as ear pulling or nabbing; Ear fullness; Decreased hearing, this may be based on reports from parents or legally authorized representatives; Discharge from the external auditory canal (following acute perforation of the tympanic membrane).
* At least two (2) of the following signs are present in at least one ear: Full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of AOM); Loss of tympanic membrane landmarks (opacity of the tympanic membrane); Abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. Have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results.
* Subject must be a suitable candidate for oral antibiotic therapy.

Exclusion Criteria:

* Previous enrollment in this study.
* Enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens.
* Presence of tympanostorny tubes or otitis externa at Evaluation 1.
* Systemic treatment with any anti-infective agent within 14 days prior to Evaluation 1 or during the study.
* Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.
* Concomitant infection that requires additional antimicrobial therapy.
* Evidence of chronic, suppurative otitis media.
* Evidence of perforation of the tympanic membrane \> 24 hours.
* Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
* Immunocompromised subject (e.g., neutropenic subjects).
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Any expectation that treatment with probenecid will be expected during the study drug administration period.
* Known significant renal or hepatic impairment.

Primary outcomes:
measure: Clinical cure rate at Evaluation 2
timeFrame: 9 days
Secondary outcomes:
measure: Sustained clinical cure rate at Evaluation 4
timeFrame: 25 days
Other outcomes:
Locations:
city: Columbiana
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Ozark
country: United States
state: Alabama
city: Fresno
country: United States
state: California
city: Fresno
country: United States
state: California
city: Marietta
country: United States
state: Georgia
city: Stone Mountain
country: United States
state: Georgia
city: Dubuque
country: United States
state: Iowa
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Cadillac
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Portage
country: United States
state: Michigan
city: Richland
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Columbus
country: United States
state: Ohio
city: Huber Heights
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Lake Jackson
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Vienna
country: United States
state: Virginia
city: Monroe
country: United States
state: Wisconsin
Study officials:
References: