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Home > "S" Clinical Trials Conditions > Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media  Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media
Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media
For Condition: Otitis Media
Status: Completed
Sponsor(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Months/5 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 190
Location and Contact Information:
Soroka Medical Center
Beer Sheva, ,
Israel
LSU Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
Neeman - Instituto Costarricense de Investigaciones Clinicas
San Jose, ,
Costa Rica
Hospital de Clinicas "Jose de San Martin"
Buenos Aires, ,
Argentina
University Hospitals of Cleveland
Cleveland, Ohio, 44106
United States
The Children's Hospital of Denver
Denver, Colorado, 80218
United States
American Fork Hospital
American Fork, Utah, 84003
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Children's Hospital of Orange County
Orange County, California, 92868
United States
Hospital Britanico de Buenos Aires
Buenos Aires, ,
Argentina
Additional Information:
Study ID Numbers: LOFBO-OTMD-001;
Study Start Date: June 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044473
Other Otitis Media Studies:
1. Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
2. Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
3. Acute Otitis Media: Adjuvant Therapy to Improve Outcome
4. Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media
Related Studies:
Other Otitis Media Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media
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