Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media
Intervention: levofloxacin; amoxicillin/clavulanate (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose).
Secondary outcome: 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
This is a randomized, active-comparator, multicenter study consisting of 3 phases: a
Pretreatment (Screening) Phase, a Treatment Phase, and a Posttreatment Phase. Subject
eligibility will be determined at the screening visit based on signs and symptoms of acute
otitis media (e. g., middle ear effusion, acute inflammation, acute purulent otorrhea) and
criteria for recurrent and/or persistent acute otitis media. Eligible subjects will be
randomized and drug will be dispensed by a study coordinator who will instruct parents and
the subject about the importance of not revealing the assigned therapy to the subject's
evaluator. Each subject will have an evaluator who will remain blinded to the subject's
therapy throughout the study. Clinical assessments performed by a blinded evaluator at
several time points throughout the study will be used to evaluate efficacy. Safety will be
evaluated throughout the study by assessment of adverse events and changes in physical
examinations (including musculoskeletal examination with evaluation of joints), vital signs,
and clinical laboratory findings. Supplementary safety evaluations for musculoskeletal
adverse events will be performed throughout the study. All subjects who enroll in this study
and take at least 1 dose of levofloxacin or amoxicillin/clavulanate will be eligible to
rollover into a long-term surveillance study primarily focused on the musculoskeletal
system. 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. Either levofloxacin 10
mg/kg twice daily for 10 days (maximum daily dose of 500 mg) or amoxicillin/clavulanate
(14: 1) 45 mg amoxicillin/kg twice daily for 10 days (maximum daily dose of 3600 mg
amoxicillin). Both study drugs will be given orally as a liquid suspension formulation
Minimum age: 6 Months.
Maximum age: 5 Years.
- 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.
- 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
- 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
Locations and Contacts
Starting date: November 2002
Last updated: January 7, 2011