BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Phase 3

Completed

• Conditions: Infectious Diseases
• Interventions: Drug: Non-quinolone antibiotic; Drug: Ciprofloxacin

• Registration Number: NCT00761462
• Lead Sponsor: Bayer

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 natural occurrence of such musculoskeletal conditions is in the general pediatric population.

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 intervention in study drug administration.

Study Timeline

• Study Start: 1999-10
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2009-03-11
• Results First Posted: 2009-04-14
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1029

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-quinolone antibiotic	Non-quinolone antibiotic	Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Ciprofloxacin	Ciprofloxacin	Subjects receiving Ciprofloxacin (group followed-up for 5 years)

Primary Outcome Measures

Name	Time	Method
Incidence of Arthropathy (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Arthropathy, as assessed by independent safety committee. The committee, after reviewing data related to musculoskeletal events, decided whether each patient had arthropathy or not. Each incidence includes number shown at previous time point, plus any new patients with the event. The 112/20 arthropathies are mentioned in the other Adverse Events section as well.
Incidence of Nervous System Events (Cumulative)	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Any event within the MedDRA system organ class 'Nervous System disorders'. Each incidence includes number shown at the previous time point, plus any new patients with the event.