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

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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Locations
Status
LocationsStatus
Locations

Montreal Children's Hospital

Montreal, Canada, H3H 1P3

Status
Completed
 
Locations

Integrated Research Group

Corona, United States, 92879

Status
Completed
 
Locations

Nebraska Clinical Research Center

Omaha, United States, 68114

Status
Completed
 
Locations

Akron Children's Hospital

Akron, United States, 44308-1062

Status
Completed
 
Locations

Kentucky Pediatric/Adult Research Center

Bardstown, United States, 40004

Status
Completed
 
Locations

Allergy, Asthma & Clinical Research Center

Oklahoma City, United States, 73120

Status
Completed
 
Locations

Children's Hospital of New Orleans

New Orleans, United States, 70118-5799

Status
Completed
 
Locations

Creighton University

Omaha, United States, 68131

Status
Completed
 
Locations

Hawaii Pacific Health

Honolulu, United States, 96813

Status
Completed
 
Locations

Fairview Red Wing Medical Center

Red Wing, United States, 55066-0095

Status
Completed
 
Locations

Southland Clinical Research Center

Fountain Valley, United States, 92708

Status
Completed
 
Locations

Long Beach Memorial Medical Center

Long Beach, United States, 90806

Status
Completed
 
Locations

LaSalle Medical Associates

San Bernardino, United States, 92411

Status
Completed
 
Locations

Center for Pediatric Research

Norfolk, United States, 23510

Status
Completed
 
Locations

Pediatric Partners

Jupiter, United States, 33458

Status
Completed
 
Locations

Family Medical Center at Heritage

Elverson, United States, 19520

Status
Completed
 
Locations

Professional Otolaryngology Associates

Voorhees, United States, 08043

Status
Completed
 
Locations

Community Care

Idaho Falls, United States, 83404

Status
Completed
 
Locations

Professional Quality Research

Austin, United States, 78756

Status
Completed
 
Locations

Miami Children's Hospital

Miami, United States, 33155

Status
Completed
 
Locations

Children's Hospital of Oklahoma

Oklahoma City, United States, 73104

Status
Completed
 
Locations

Cook Children's Medical Center

Fort Worth, United States, 76104

Status
Completed
 
Locations

University of Oklahoma - Tulsa

Tulsa, United States, 74135

Status
Completed
 
Locations

First Allergy and Clinical Research Center

Centennial, United States, 80112

Status
Completed
 
Locations

Children's Hospital of Orange County

Orange, United States, 92868-3974

Status
Completed
 
Locations

University of Florida - Jacksonville

Jacksonville, United States, 32209

Status
Completed
 
Locations

Hackensack University Medical Center

Hackensack, United States, 07601-1991

Status
Completed
 
Locations

New York-Presbyterian Hospital

New York, United States, 10021-4885

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

Clinics of North Texas

Fort Smith, United States, 72903

Status
Completed
 
Locations

Ear, Nose and Throat of Georgia

Snellville, United States, 30078

Status
Completed
 
Locations

St. Jude Children's Research Hospital

Memphis, United States, 38105-2729

Status
Completed
 
Locations

Millenium Research

Benbrook, United States, 76126

Status
Completed
 
Locations

Center for Pediatric Rehabilitation

Pensacola, United States, 32504

Status
Completed
 
Locations

The Children's Hospital

Denver, United States, 80218

Status
Completed
 
Locations

Columbia University

New York, United States, 10032

Status
Completed
 
Locations

University of Texas Medical Branch at Galveston

Galveston, United States, 77555-0371

Status
Completed
 
Locations

University of South Florida

Tampa, United States, 33606

Status
Completed
 
Locations

Southern Illinois University School of Medicine

Springfield, United States, 62701

Status
Completed
 
Locations

Sandcastle Pediatrics

Ft. Walton Beach, United States, 32548

Status
Completed
 
Locations

Advocate Lutheran General Hospital

Park Ridge, United States, 60068-1174

Status
Completed
 
Locations

Amedica Research Institute

Hialeah, United States, 33013

Status
Completed
 
Locations

University of Florida-Gainesville

Gainesville, United States, 32610-0254

Status
Completed
 
Locations

Children's Urology Associates

Las Vegas, United States, 89109

Status
Completed
 
Locations

SUNY University Hospital/Health Science Center

Stony Brook, United States, 11794-8111

Status
Completed
 
Locations

Wilmington Health Associates

Wilmington, United States, 28401

Status
Completed
 
Locations

Discovery Alliance, Inc.

Mobile, United States, 36608

Status
Completed
 
Locations

Riley Hospital For Children

Indianapolis, United States, 46202

Status
Completed
 
Locations

Medical University of South Carolina Medical Center

Charleston, United States, 29425

Status
Completed
 
Locations

West Virginia University Hospitals

Morgantown, United States, 26506

Status
Completed
 
Locations

Accelovance

Houston, United States, 77024

Status
Completed
 
Locations

Florida West Coast Clinical Research Group

Tampa, United States, 33607

Status
Completed
 
Locations

The Children's Medical Center of Dayton

Dayton, United States, 45404-1815

Status
Completed
 
Locations

Tod Children's Hospital

Youngstown, United States, 44501-0240

Status
Completed
 
Locations

MetroHealth Medical Center

Cleveland, United States, 44109-1998

Status
Completed
 
Locations

Long Island Jewish Medical Center

New Hyde Park, United States, 11040

Status
Completed
 
Locations

Clinical Health Research Institute for the Sciences

Pico Rivera, United States, 90660

Status
Completed
 
Locations

Scott & White Hospital-Temple

Temple, United States, 76508

Status
Completed
 
Locations

Weight Management Medical Center

Overland Park, United States, 66215

Status
Completed
 
Locations

Pediatric Medical Associates

Havertown, United States, 19083

Status
Completed
 
Locations

University of Texas M.D. Anderson Cancer Center

Houston, United States, 77030

Status
Completed
 
Locations

Medical College of Virginia

Richmond, United States, 23298

Status
Completed
 
Locations

Children's Hospital Boston

Boston, United States, 02115

Status
Completed
 
Locations

Jacobi Medical Center

Bronx, United States, 10461

Status
Completed
 
Locations

Allergy & Asthma Research Center of El Paso

El Paso, United States, 79925

Status
Completed
 
Locations

Urology for Children, LLC

Voorhees, United States, 08043

Status
Completed
 
Locations

Wee Care Pediatrics

Layton, United States, 84041

Status
Completed
 
Locations

Coastal Medical Research Group, Inc.

San Luis Obispo, United States, 93405

Status
Completed
 

Trial Design