check_circleStudy Completed

Infectious Diseases

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Trial 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.

Key Participants Requirements

Sex

Both

Age

2 - 16 Years
  • - 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
  • - 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.

Trial summary

Enrollment Goal
1029
Trial Dates
October 1999 - January 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Cipro (Ciprofloxacin, BAYQ3939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Montreal Children's HospitalMontreal, H3H 1P3, Canada
Completed
Integrated Research GroupCorona, 92879, United States
Completed
Nebraska Clinical Research CenterOmaha, 68114, United States
Completed
Akron Children's HospitalAkron, 44308-1062, United States
Completed
Kentucky Pediatric/Adult Research CenterBardstown, 40004, United States
Completed
Allergy, Asthma & Clinical Research CenterOklahoma City, 73120, United States
Completed
Children's Hospital of New OrleansNew Orleans, 70118-5799, United States
Completed
Creighton UniversityOmaha, 68131, United States
Completed
Hawaii Pacific HealthHonolulu, 96813, United States
Completed
Fairview Red Wing Medical CenterRed Wing, 55066-0095, United States
Completed
Southland Clinical Research CenterFountain Valley, 92708, United States
Completed
Long Beach Memorial Medical CenterLong Beach, 90806, United States
Completed
LaSalle Medical AssociatesSan Bernardino, 92411, United States
Completed
Center for Pediatric ResearchNorfolk, 23510, United States
Completed
Pediatric PartnersJupiter, 33458, United States
Completed
Family Medical Center at HeritageElverson, 19520, United States
Completed
Professional Otolaryngology AssociatesVoorhees, 08043, United States
Completed
Community CareIdaho Falls, 83404, United States
Completed
Professional Quality ResearchAustin, 78756, United States
Completed
Miami Children's HospitalMiami, 33155, United States
Completed
Children's Hospital of OklahomaOklahoma City, 73104, United States
Completed
Cook Children's Medical CenterFort Worth, 76104, United States
Completed
University of Oklahoma - TulsaTulsa, 74135, United States
Completed
First Allergy and Clinical Research CenterCentennial, 80112, United States
Completed
Children's Hospital of Orange CountyOrange, 92868-3974, United States
Completed
University of Florida - JacksonvilleJacksonville, 32209, United States
Completed
Hackensack University Medical CenterHackensack, 07601-1991, United States
Completed
New York-Presbyterian HospitalNew York, 10021-4885, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
Clinics of North TexasFort Smith, 72903, United States
Completed
Ear, Nose and Throat of GeorgiaSnellville, 30078, United States
Completed
St. Jude Children's Research HospitalMemphis, 38105-2729, United States
Completed
Millenium ResearchBenbrook, 76126, United States
Completed
Center for Pediatric RehabilitationPensacola, 32504, United States
Completed
The Children's HospitalDenver, 80218, United States
Completed
Columbia UniversityNew York, 10032, United States
Completed
University of Texas Medical Branch at GalvestonGalveston, 77555-0371, United States
Completed
University of South FloridaTampa, 33606, United States
Completed
Southern Illinois University School of MedicineSpringfield, 62701, United States
Completed
Sandcastle PediatricsFt. Walton Beach, 32548, United States
Completed
Advocate Lutheran General HospitalPark Ridge, 60068-1174, United States
Completed
Amedica Research InstituteHialeah, 33013, United States
Completed
University of Florida-GainesvilleGainesville, 32610-0254, United States
Completed
Children's Urology AssociatesLas Vegas, 89109, United States
Completed
SUNY University Hospital/Health Science CenterStony Brook, 11794-8111, United States
Completed
Wilmington Health AssociatesWilmington, 28401, United States
Completed
Discovery Alliance, Inc.Mobile, 36608, United States
Completed
Riley Hospital For ChildrenIndianapolis, 46202, United States
Completed
Medical University of South Carolina Medical CenterCharleston, 29425, United States
Completed
West Virginia University HospitalsMorgantown, 26506, United States
Completed
AccelovanceHouston, 77024, United States
Completed
Florida West Coast Clinical Research GroupTampa, 33607, United States
Completed
The Children's Medical Center of DaytonDayton, 45404-1815, United States
Completed
Tod Children's HospitalYoungstown, 44501-0240, United States
Completed
MetroHealth Medical CenterCleveland, 44109-1998, United States
Completed
Long Island Jewish Medical CenterNew Hyde Park, 11040, United States
Completed
Clinical Health Research Institute for the SciencesPico Rivera, 90660, United States
Completed
Scott & White Hospital-TempleTemple, 76508, United States
Completed
Weight Management Medical CenterOverland Park, 66215, United States
Completed
Pediatric Medical AssociatesHavertown, 19083, United States
Completed
University of Texas M.D. Anderson Cancer CenterHouston, 77030, United States
Completed
Medical College of VirginiaRichmond, 23298, United States
Completed
Children's Hospital BostonBoston, 02115, United States
Completed
Jacobi Medical CenterBronx, 10461, United States
Completed
Allergy & Asthma Research Center of El PasoEl Paso, 79925, United States
Completed
Urology for Children, LLCVoorhees, 08043, United States
Completed
Wee Care PediatricsLayton, 84041, United States
Completed
Coastal Medical Research Group, Inc.San Luis Obispo, 93405, United States

Primary Outcome

  • Incidence of Arthropathy (Cumulative)
    date_rangeTime Frame:
    4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of Nervous System Events (Cumulative)
    date_rangeTime Frame:
    4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2