BAY 0 9867 Cipro Pediatric Use Study (QUIP)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00761462
First received: September 26, 2008
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Infectious Diseases
Drug: Ciprofloxacin
Drug: Non-quinolone antibiotic
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of Arthropathy (Cumulative) [ Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1029
Study Start Date: October 1999
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Drug: Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Active Comparator: Non-quinolone antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Drug: Non-quinolone antibiotic
Common used dose and route

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.

  Eligibility

Ages Eligible for Study:   2 Months to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761462

  Show 67 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00761462     History of Changes
Other Study ID Numbers: 100201
Study First Received: September 26, 2008
Results First Received: December 19, 2008
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Pediatrics
Safety
Musculoskeletal System
Neurologic Manifestations
Joint Diseases
Joint Deformities, Acquired

Additional relevant MeSH terms:
Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ciprofloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014