BAY 0 9867 Cipro Pediatric Use Study (QUIP)

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Joint Deformities, Acquired Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montreal, Quebec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin

Drug

Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label

Non-quinolone antibiotic

Drug

Common used dose and route

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start: 1999
Primary completion: 2008
Study completion: 2008
First posted: Sep 29, 2008
Registry last updated: Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed