BAY 0 9867 Cipro Pediatric Use Study (QUIP) - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00761462

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.

Condition	Intervention	Phase
Infectious Diseases	Drug: Ciprofloxacin Drug: any other antibiotics	Phase III

MedlinePlus related topics: Antibiotics Joint Disorders

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Parallel Assignment, Safety Study, Treatment
Official Title:	A Prospective, Open-Label, Non-Randomized, Naturalistic, Long-Term Safety Surveillance, Observational Study of Ciprofloxacin (Either as Oral Suspension, Oral Tablets or Sequential IV - Oral Therapy or Purely IV Therapy) in the Treatment of Pediatric Patients With a Variety of Infectious Diagnoses

Further study details as provided by Bayer:

Primary Outcome Measures:

Long-term postexposure, follow-up safety data to determine the potential long-term incidence of arthropathy [ Time Frame: within 48 hrs of prior to onset of therapy and then 4-6 weeks post therapy Phone calls were made at 3,6,9 and 12 months then quarterly therafter for 5 years ] [ Designated as safety issue: Yes ]
Short and long-term neurological system tolerability of courses of ciprofloxacin therapy [ Time Frame: within 48 hrs of prior to onset of therapy and then 4-6 weeks post therapy Phone calls were made at 3,6,9 and 12 months then quarterly therafter for 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	900
Study Start Date:	April 2000
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Ciprofloxacin Either as oral suspension, oral tablets or sequential IV - oral therapy or purely IV therapy according to label
Arm 2: Active Comparator	Drug: any other antibiotics Common used dose and route

Eligibility

Ages Eligible for Study:	2 Months to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761462

Show 66 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	100201
Study First Received:	September 26, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00761462 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Joint Deformities, Acquired
Joint Diseases
Musculoskeletal System

Neurologic Manifestations
Pediatrics
Safety

Study placed in the following topic categories:

Ciprofloxacin
Anti-Bacterial Agents
Joint Diseases
Neurologic Manifestations
Congenital Abnormalities

Additional relevant MeSH terms:

Anti-Infective Agents
Ciprofloxacin
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 13, 2009