Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1029 participants
INTERVENTIONAL
1999-10-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Non-quinolone antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Non-quinolone antibiotic
Common used dose and route
Interventions
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Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Non-quinolone antibiotic
Common used dose and route
Eligibility Criteria
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Inclusion Criteria
* A parent/caregiver must sign an informed consent
* Patient must provide assent, as appropriate based on local institutional review board guidelines
Exclusion Criteria
* exacerbations of cystic fibrosis (CF)
* meningitis
* Brain abscess
* bacterial endocarditis,
* Bone and joint infections
* having any of the following conditions but lacking a personal history may be admitted to the trial:
* Arthritis
* Juvenile rheumatoid arthritis (JRA)
* Rheumatoid arthritis (RA)
* Systemic lupus erythematosis (SLE)
* History of rheumatic fever
* Psoriasis
* Inflammatory bowel disease
* Osteoarthritis (OA)
* Known underlying rheumatological disease, joint problems known to be associated with arthropathy.
* Patients with any pre-treatment baseline musculoskeletal exam abnormalities
* Known risk of experiencing seizures, a history of any convulsive disorders
* Requiring any concomitant therapeutic course of systemic antibacterial agent
* Participation in any industry-sponsored clinical drug development study within one month prior to this study
* Known significant liver impairment (ALAT/ASAT and/or baseline bilirubin \> 3 times upper limit of normal)
* Known significant renal insufficiency (calculated creatinine clearance of \< 30 ml/min/1.73 m²)
* Are pregnant or lactating, or are sexually active and using unreliable contraception.
2 Months
16 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare Pharmaceuticals Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Mobile, Alabama, United States
Fort Smith, Arkansas, United States
Corona, California, United States
Fountain Valley, California, United States
Long Beach, California, United States
Orange, California, United States
Pico Rivera, California, United States
San Bernardino, California, United States
San Luis Obispo, California, United States
Centennial, Colorado, United States
Denver, Colorado, United States
Fort Walton Beach, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Snellville, Georgia, United States
Honolulu, Hawaii, United States
Idaho Falls, Idaho, United States
Park Ridge, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Bardstown, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Red Wing, Minnesota, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Voorhees Township, New Jersey, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
Stony Brook, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Wilmington, North Carolina, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Youngstown, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Elverson, Pennsylvania, United States
Havertown, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Benbrook, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Temple, Texas, United States
Layton, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Morgantown, West Virginia, United States
Montreal, Quebec, Canada
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2014-004622-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
100201
Identifier Type: -
Identifier Source: org_study_id
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