Trial Condition(s):
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Bayer Identifier:
100201
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such musculoskeletal conditions is in the general pediatric population.
Inclusion Criteria
- Patient is >/= 2 months of age through 16 years of age - A parent/caregiver must sign an informed consent - Patient must provide assent, as appropriate based on local institutional review board guidelines
Exclusion Criteria
- Patients presenting with the following conditions: -- 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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Montreal Children's Hospital Montreal, Canada, H3H 1P3 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Integrated Research Group Corona, United States, 92879 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nebraska Clinical Research Center Omaha, United States, 68114 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akron Children's Hospital Akron, United States, 44308-1062 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kentucky Pediatric/Adult Research Center Bardstown, United States, 40004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allergy, Asthma & Clinical Research Center Oklahoma City, United States, 73120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of New Orleans New Orleans, United States, 70118-5799 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Creighton University Omaha, United States, 68131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hawaii Pacific Health Honolulu, United States, 96813 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fairview Red Wing Medical Center Red Wing, United States, 55066-0095 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southland Clinical Research Center Fountain Valley, United States, 92708 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Long Beach Memorial Medical Center Long Beach, United States, 90806 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LaSalle Medical Associates San Bernardino, United States, 92411 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Pediatric Research Norfolk, United States, 23510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pediatric Partners Jupiter, United States, 33458 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Medical Center at Heritage Elverson, United States, 19520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Professional Otolaryngology Associates Voorhees, United States, 08043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Community Care Idaho Falls, United States, 83404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Professional Quality Research Austin, United States, 78756 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miami Children's Hospital Miami, United States, 33155 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Oklahoma Oklahoma City, United States, 73104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cook Children's Medical Center Fort Worth, United States, 76104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Oklahoma - Tulsa Tulsa, United States, 74135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations First Allergy and Clinical Research Center Centennial, United States, 80112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital of Orange County Orange, United States, 92868-3974 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida - Jacksonville Jacksonville, United States, 32209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hackensack University Medical Center Hackensack, United States, 07601-1991 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New York-Presbyterian Hospital New York, United States, 10021-4885 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinics of North Texas Fort Smith, United States, 72903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ear, Nose and Throat of Georgia Snellville, United States, 30078 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Jude Children's Research Hospital Memphis, United States, 38105-2729 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Millenium Research Benbrook, United States, 76126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Pediatric Rehabilitation Pensacola, United States, 32504 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Children's Hospital Denver, United States, 80218 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Columbia University New York, United States, 10032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas Medical Branch at Galveston Galveston, United States, 77555-0371 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of South Florida Tampa, United States, 33606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southern Illinois University School of Medicine Springfield, United States, 62701 | Status Completed | Contact Us: E-mail: [email protected].com Phone: Not Available |
Locations Sandcastle Pediatrics Ft. Walton Beach, United States, 32548 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Advocate Lutheran General Hospital Park Ridge, United States, 60068-1174 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Amedica Research Institute Hialeah, United States, 33013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida-Gainesville Gainesville, United States, 32610-0254 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Urology Associates Las Vegas, United States, 89109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY University Hospital/Health Science Center Stony Brook, United States, 11794-8111 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wilmington Health Associates Wilmington, United States, 28401 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Discovery Alliance, Inc. Mobile, United States, 36608 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Riley Hospital For Children Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical University of South Carolina Medical Center Charleston, United States, 29425 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West Virginia University Hospitals Morgantown, United States, 26506 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Accelovance Houston, United States, 77024 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Florida West Coast Clinical Research Group Tampa, United States, 33607 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Children's Medical Center of Dayton Dayton, United States, 45404-1815 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tod Children's Hospital Youngstown, United States, 44501-0240 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MetroHealth Medical Center Cleveland, United States, 44109-1998 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Long Island Jewish Medical Center New Hyde Park, United States, 11040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Health Research Institute for the Sciences Pico Rivera, United States, 90660 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scott & White Hospital-Temple Temple, United States, 76508 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Weight Management Medical Center Overland Park, United States, 66215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pediatric Medical Associates Havertown, United States, 19083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas M.D. Anderson Cancer Center Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical College of Virginia Richmond, United States, 23298 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital Boston Boston, United States, 02115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacobi Medical Center Bronx, United States, 10461 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allergy & Asthma Research Center of El Paso El Paso, United States, 79925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology for Children, LLC Voorhees, United States, 08043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wee Care Pediatrics Layton, United States, 84041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coastal Medical Research Group, Inc. San Luis Obispo, United States, 93405 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A prospective, open-label, non-randomized, naturalistic, long-term safety surveillance, observational study of either ciprofloxacin (either as oral suspension, oral tablets or sequential IV followed by oral therapy or purely IV therapy) or a non-quinolone antibiotic (either as oral suspension, oral tablets or sequential IV followed by oral therapy or purely IV therapy) in the treatment of pediatric patients with infectious diagnoses
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Incidence of Arthropathy (Cumulative)Timeframe: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
- Incidence of Nervous System Events (Cumulative)Timeframe: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Additional Information
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