BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Completed · Phase 3

Conditions studied: Infectious Diseases

In brief

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.

Key facts

Study ID

NCT00761462

Run by

Bayer

People needed

1029

Starts

1999-10-01

Expected to finish

2008-01-01

Last updated by the study team

2015-07-31

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Las Vegas, Nevada, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — New Hyde Park, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Akron, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Youngstown, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Elverson, Pennsylvania, United States
• Study site — Havertown, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Benbrook, Texas, United States
• Study site — El Paso, Texas, United States
• Study site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.