BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Infectious Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761462
• Other study ID #: 100201
• Secondary ID: 2014-004622-18
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: July 13, 2015
• Start date: October 1999
• Est. completion date: January 2008

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 16 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

Drug:
• Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
• Non-quinolone antibiotic
Common used dose and route

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Arthropathy (Cumulative)	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.	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Yes
Primary	Incidence of Nervous System Events (Cumulative)	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.	4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment	Yes

External Links

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