Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Levofloxacin; Ofloxacin

Criteria

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