Clinical trial NCT00645203: Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Otitis Media
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 447
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Bacteriological Response
timeFrame: 30 days
measure: Clinical response
timeFrame: 30 days
measure: Change in the otoscopic findings
timeFrame: 30 days
Secondary outcomes:
measure: Physical exam; Vital signs; Use of concomitant medications
timeFrame: 59 days
measure: Adverse events assessment
timeFrame: 45 days with follow-up to a satisfactory conclusion
measure: Laboratory evaluations
timeFrame: 30 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Clovis
country: United States
state: California
city: Dinuba
country: United States
state: California
city: Folsom
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Brooklyn
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Erie
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Providencia
country: Chile
state: Santiago
city: Puente Alto, Santiago
country: Chile
city: La Uruca
country: Costa Rica
state: San Jose
city: San Jose
country: Costa Rica
city: Santo Domingo
country: Dominican Republic
city: Guatemala City
country: Guatemala
city: Guatemala City
country: Guatemala
city: Beer Sheva
country: Israel
city: Panama
country: Panama
Study officials:
References: