Phase 3
Completed N=1,029
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Source: ClinicalTrials.gov NCT00761462 ↗Enrolled (actual)
1,029
Serious AEs
3.1%
Results posted
Apr 2009
Primary outcomePrimary: Incidence of Arthropathy (Cumulative) — 39; 9; 64; 16 participants
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 natural occurrence of such musculoskeletal conditions is in the general pediatric population.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Arthropathy (Cumulative) |
39; 9; 64; 16; 112; 20 | — |
| PRIMARY Incidence of Nervous System Events (Cumulative) |
38; 10; 49; 13; 56; 17 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00761462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.