The purpose of the study is to assess the rate of eradication of bacteria from the middle ear fluid 4 to 6 days after the initiation of treatment with levofloxacin in infants and children who have acute otitis media and are at high risk for infections that are difficult to treat.

Condition	Treatment or Intervention	Phase
Otitis Media	Drug: Levofloxacin	Phase III

Further Study Details: 

Expected Total Enrollment:  190

Ages Eligible for Study:  6 Months   -   5 Years,  Genders Eligible for Study:  Both

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 AOM is defined as having one of the following: Recurrent 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.
• 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.

California
      Children's Hospital of Orange County, Orange County,  California,  92868,  United States
Colorado
      The Children's Hospital of Denver, Denver,  Colorado,  80218,  United States
Louisiana
      LSU Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States
New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44106,  United States
Utah
      American Fork Hospital, American Fork,  Utah,  84003,  United States
Argentina
      Hospital de Clinicas "Jose de San Martin", Buenos Aires,  Argentina
      Hospital Britanico de Buenos Aires, Buenos Aires,  Argentina
Costa Rica
      Neeman - Instituto Costarricense de Investigaciones Clinicas, San Jose,  Costa Rica
Israel
      Soroka Medical Center, Beer-Sheva,  Israel

Study ID Numbers:  LOFBO-OTMD-001
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  August 29, 2002
ClinicalTrials.gov Identifier:  NCT00044473
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08