Trial Condition(s):

Infectious Diseases

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Bayer Identifier:

100201

ClinicalTrials.gov Identifier:

NCT00761462

EudraCT Number:

2014-004622-18

EU CT Number:

Not Available

Study Completed

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
1029
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Cipro (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteers
No

Where to Participate

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Montreal Children's Hospital

Montreal, Canada, H3H 1P3

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Integrated Research Group

Corona, United States, 92879

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Nebraska Clinical Research Center

Omaha, United States, 68114

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Akron Children's Hospital

Akron, United States, 44308-1062

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Kentucky Pediatric/Adult Research Center

Bardstown, United States, 40004

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Allergy, Asthma & Clinical Research Center

Oklahoma City, United States, 73120

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Children's Hospital of New Orleans

New Orleans, United States, 70118-5799

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Creighton University

Omaha, United States, 68131

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Hawaii Pacific Health

Honolulu, United States, 96813

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Fairview Red Wing Medical Center

Red Wing, United States, 55066-0095

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Southland Clinical Research Center

Fountain Valley, United States, 92708

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Long Beach Memorial Medical Center

Long Beach, United States, 90806

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LaSalle Medical Associates

San Bernardino, United States, 92411

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Center for Pediatric Research

Norfolk, United States, 23510

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Pediatric Partners

Jupiter, United States, 33458

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Family Medical Center at Heritage

Elverson, United States, 19520

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Professional Otolaryngology Associates

Voorhees, United States, 08043

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Community Care

Idaho Falls, United States, 83404

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Professional Quality Research

Austin, United States, 78756

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Miami Children's Hospital

Miami, United States, 33155

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Children's Hospital of Oklahoma

Oklahoma City, United States, 73104

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Cook Children's Medical Center

Fort Worth, United States, 76104

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University of Oklahoma - Tulsa

Tulsa, United States, 74135

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First Allergy and Clinical Research Center

Centennial, United States, 80112

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Children's Hospital of Orange County

Orange, United States, 92868-3974

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University of Florida - Jacksonville

Jacksonville, United States, 32209

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Hackensack University Medical Center

Hackensack, United States, 07601-1991

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New York-Presbyterian Hospital

New York, United States, 10021-4885

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Duke University Medical Center

Durham, United States, 27710

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Clinics of North Texas

Fort Smith, United States, 72903

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Ear, Nose and Throat of Georgia

Snellville, United States, 30078

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St. Jude Children's Research Hospital

Memphis, United States, 38105-2729

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Millenium Research

Benbrook, United States, 76126

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Center for Pediatric Rehabilitation

Pensacola, United States, 32504

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The Children's Hospital

Denver, United States, 80218

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Columbia University

New York, United States, 10032

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University of Texas Medical Branch at Galveston

Galveston, United States, 77555-0371

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University of South Florida

Tampa, United States, 33606

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Southern Illinois University School of Medicine

Springfield, United States, 62701

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Sandcastle Pediatrics

Ft. Walton Beach, United States, 32548

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Advocate Lutheran General Hospital

Park Ridge, United States, 60068-1174

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Amedica Research Institute

Hialeah, United States, 33013

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University of Florida-Gainesville

Gainesville, United States, 32610-0254

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Children's Urology Associates

Las Vegas, United States, 89109

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SUNY University Hospital/Health Science Center

Stony Brook, United States, 11794-8111

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Wilmington Health Associates

Wilmington, United States, 28401

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Discovery Alliance, Inc.

Mobile, United States, 36608

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Riley Hospital For Children

Indianapolis, United States, 46202

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Medical University of South Carolina Medical Center

Charleston, United States, 29425

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West Virginia University Hospitals

Morgantown, United States, 26506

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Accelovance

Houston, United States, 77024

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Florida West Coast Clinical Research Group

Tampa, United States, 33607

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The Children's Medical Center of Dayton

Dayton, United States, 45404-1815

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Tod Children's Hospital

Youngstown, United States, 44501-0240

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MetroHealth Medical Center

Cleveland, United States, 44109-1998

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Long Island Jewish Medical Center

New Hyde Park, United States, 11040

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Clinical Health Research Institute for the Sciences

Pico Rivera, United States, 90660

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Scott & White Hospital-Temple

Temple, United States, 76508

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Weight Management Medical Center

Overland Park, United States, 66215

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Pediatric Medical Associates

Havertown, United States, 19083

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University of Texas M.D. Anderson Cancer Center

Houston, United States, 77030

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Medical College of Virginia

Richmond, United States, 23298

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Children's Hospital Boston

Boston, United States, 02115

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Jacobi Medical Center

Bronx, United States, 10461

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Allergy & Asthma Research Center of El Paso

El Paso, United States, 79925

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Urology for Children, LLC

Voorhees, United States, 08043

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Wee Care Pediatrics

Layton, United States, 84041

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Coastal Medical Research Group, Inc.

San Luis Obispo, United States, 93405

Trial Design