Otitis Media Clinical Trial
Official title:
A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.
Status | Completed |
Enrollment | 1643 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 5 Years |
Eligibility |
Inclusion Criteria: - Males or females, aged > or equal to 6 months to < 5 years - Clinical signs and symptoms of otitis media including middle ear effusion and acute inflammation or acute purulent otorrhea - At risk for difficult to treat Acute Otitis Media (AOM) is defined as having one of the following: recurrent Otitis Media (OM) as defined by 3 or more episodes in last 6 months or 4 or more episodes in past year or persistent OM as defined by evidence of AOM on 3rd day after starting any antimicrobial regimen - Written consent/assent - Have not participated in an experimental drug or medical device trial within 30 days prior to start of study. Exclusion Criteria: - History of hypersensitivity or serious reaction to any quinolone - Tympanostomy tube in the affected ear - Requires use of systemic antibiotic other than study drug - Has a serious bacterial infection in addition to AOM that may interfere with assessment of their clinical response - Diagnosed with bacterial meningitis - Abnormal renal function defined as serum creatinine >0.5 mg/dL in infants 6 months or older and 0.8 mg/dL in children between 1 and 5 years of age - History or presence of arthropathy or periarticular disease or any other musculoskeletal signs or symptoms that may confound a future safety exam of MS events - Has a high probability of death during the study - Poorly controlled seizure disorder or at risk for seizures - HIV infection requiring pneumocystis carinii pneumonia prophylaxis - Chronic use of corticosteroids 2mg/kg or more or 20mg/day for 14 or more days - Amoxicillin/clavulanate (90 mg/kg/day) use within 3 days before the first dose of the study drug - Previous participation in this protocol or another levofloxacin clinical study - Employees of the investigator or study center with direct involvement in the study - Family members are also excluded |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose). | |||
Secondary | Clinical success (cured and improved versus failed) rate at Visit 3 (2 to 5 days after the last dose) and Visit 4 (10 to 17 days after the last dose); clinical cure rate at Visit 4 (10 to 17 days after the last dose); safety evaluations |
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