BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Bayer

Status and phase: Completed; Phase 3

Conditions: Infectious Diseases

Treatments: Drug: Non-quinolone antibiotic; Drug: Ciprofloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00761462

2014-004622-18 (EudraCT Number)

100201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,029 patients

Sex: All

Ages: 2 months to 16 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,029 participants in 2 patient groups

Ciprofloxacin

Experimental group

Description:

Subjects receiving Ciprofloxacin (group followed-up for 5 years)

Treatment:

Drug: Ciprofloxacin

Non-quinolone antibiotic

Active Comparator group

Description:

Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Treatment:

Drug: Non-quinolone antibiotic