BAY 0 9867 Cipro Pediatric Use Study (QUIP)



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 16
Updated:4/21/2016
Start Date:October 1999
End Date:January 2008

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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

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.

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.

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.
We found this trial at
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Akron, OH
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Charleston, South Carolina 29412
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Fountain Valley, California 92708
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Ft. Walton Beach, Florida 32548
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