Clinical trial NCT00761462: BAY 0 9867 Cipro Pediatric Use Study (QUIP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Diseases
Keywords: Pediatrics
Safety
Musculoskeletal System
Neurologic Manifestations
Joint Diseases
Joint Deformities, Acquired
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 1029
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

Primary outcomes:
measure: Incidence of Arthropathy (Cumulative)
timeFrame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
measure: Incidence of Nervous System Events (Cumulative)
timeFrame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Fort Smith
country: United States
state: Arkansas
city: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Ft. Walton Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Snellville
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Idaho Falls
country: United States
state: Idaho
city: Park Ridge
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Red Wing
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Elverson
country: United States
state: Pennsylvania
city: Havertown
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Benbrook
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: