Status:
COMPLETED
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Lead Sponsor:
Bayer
Conditions:
Infectious Diseases
Eligibility:
All Genders
2-16 years
Phase:
PHASE3
Brief Summary
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 natura...
Detailed Description
This study is classified as "interventional" due to study-specific medical examinations and interventions. Regarding the study drug intake, routine administration is observed only, there is no interve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
1029 Patients enrolled
Trial Details
Trial ID
NCT00761462
Start Date
October 1 1999
End Date
January 1 2008
Last Update
July 31 2015
Active Locations (67)
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1
Mobile, Alabama, United States, 36608
2
Fort Smith, Arkansas, United States, 72903
3
Corona, California, United States, 92879
4
Fountain Valley, California, United States, 92708