BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infectious Diseases

Intervention / Treatment
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* Drug: Ciprofloxacin
* Drug: Non-quinolone antibiotic


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprofloxacin<br>Subjects receiving Ciprofloxacin (group followed-up for 5 years) | Drug: Ciprofloxacin<br>* Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label<br>|
| Active Comparator: Non-quinolone antibiotic<br>Subjects receiving non-quinolone antibiotic (group followed-up for 2 years) | Drug: Non-quinolone antibiotic<br>* Common used dose and route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Safety, Musculoskeletal System, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired