NCT00761462

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

A Prospective, Open-label, Non-randomized, Naturalistic, Long-term Safety Surveillance, Observational Study of Either Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) or a Non-quinolone Antibiotic (Either as Oral Suspension, Oral Tablets or Sequential IV Followed by Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With Infectious Diagnoses

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,029 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Months – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious Diseases

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
DRUG	Non-quinolone antibiotic	Common used dose and route

Timeline

• Start date: 1999-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2008-09-29
• Last updated: 2015-07-31
• Results posted: 2009-04-14

Locations

67 sites across 2 countries: United States, Canada