Clinical Trial: BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 b

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 Summary: 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.
Sponsor: Bayer

Current Primary Outcome:

  • Incidence of Arthropathy (Cumulative) [ Time Frame: 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) [ Time Frame: 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.


Original Primary Outcome:

  • Long-term postexposure, follow-up safety data to determine the potential long-term incidence of arthropathy [ Time Frame: within 48 hrs of prior to nset of therapy and then 4-6 weeks post therapy Phone calls were made at 3,6,9 and 12 months then quarterly therafter for 5 years ]
  • Short and long-term neurological system tolerability of courses of ciprofloxacin therapy [ Time Frame: within 48 hrs of prior to nset of therapy and then 4-6 weeks post therapy Phone calls were made at 3,6,9 and 12 months then quarterly therafter for 5 years ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bayer

Dates:
Date Received: September 26, 2008
Date Started: October 1999
Date Completion:
Last Updated: July 13, 2015
Last Verified: July 2015