Clinical trial NCT00644943: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Official title: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate 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: 425
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 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 acute otitis media \<=1 week
* Clinical signs and symptoms include \>=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
* At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
* Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results

Exclusion Criteria:

* Previous enrollment in this study.
* Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
* Presence of tympanostomy tubes or otitis externa at Evaluation 1.
* Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) 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 a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Known, severe renal impairment (i.e., creatinine clearance \< 30 mUmid1.73 m2).
* History of Augmentin-associated cholestatic jaundicehepatic dysfunction.

Primary outcomes:
measure: Clinical Cure Rate
timeFrame: 9 days
Secondary outcomes:
measure: Sustained Clinical Cure Rate
timeFrame: 28 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Ozark
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Clovis
country: United States
state: California
city: Fresno
country: United States
state: California
city: Longmont
country: United States
state: Colorado
city: Fairfield
country: United States
state: Connecticut
city: Marietta
country: United States
state: Georgia
city: Stone Mountain
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Ruston
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Kalamazoo
country: United States
state: Michigan
city: Richland
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Columbus
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
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: Vienna
country: United States
state: Virginia
Study officials:
References: