BAY 0 9867 Cipro Pediatric Use Study (QUIP)

July 13, 2015 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1029

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
    • California
      • Corona, California, United States, 92879
      • Fountain Valley, California, United States, 92708
      • Long Beach, California, United States, 90806
      • Orange, California, United States, 92868-3974
      • Pico Rivera, California, United States, 90660
      • San Bernardino, California, United States, 92411
      • San Luis Obispo, California, United States, 93405
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Denver, Colorado, United States, 80218
    • Florida
      • Ft. Walton Beach, Florida, United States, 32548
      • Gainesville, Florida, United States, 32610-0254
      • Hialeah, Florida, United States, 33013
      • Jacksonville, Florida, United States, 32209
      • Jupiter, Florida, United States, 33458
      • Miami, Florida, United States, 33155
      • Pensacola, Florida, United States, 32504
      • Tampa, Florida, United States, 33606
      • Tampa, Florida, United States, 33607
    • Georgia
      • Snellville, Georgia, United States, 30078
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Park Ridge, Illinois, United States, 60068-1174
      • Springfield, Illinois, United States, 62701
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kansas
      • Overland Park, Kansas, United States, 66215
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
    • Louisiana
      • New Orleans, Louisiana, United States, 70118-5799
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Red Wing, Minnesota, United States, 55066-0095
    • Nebraska
      • Omaha, Nebraska, United States, 68114
      • Omaha, Nebraska, United States, 68131
    • Nevada
      • Las Vegas, Nevada, United States, 89109
    • New Jersey
      • Hackensack, New Jersey, United States, 07601-1991
      • Voorhees, New Jersey, United States, 08043
    • New York
      • Bronx, New York, United States, 10461
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10032
      • New York, New York, United States, 10021-4885
      • Stony Brook, New York, United States, 11794-8111
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Akron, Ohio, United States, 44308-1062
      • Cleveland, Ohio, United States, 44109-1998
      • Dayton, Ohio, United States, 45404-1815
      • Youngstown, Ohio, United States, 44501-0240
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma City, Oklahoma, United States, 73104
      • Tulsa, Oklahoma, United States, 74135
    • Pennsylvania
      • Elverson, Pennsylvania, United States, 19520
      • Havertown, Pennsylvania, United States, 19083
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Memphis, Tennessee, United States, 38105-2729
    • Texas
      • Austin, Texas, United States, 78756
      • Benbrook, Texas, United States, 76126
      • El Paso, Texas, United States, 79925
      • Fort Worth, Texas, United States, 76104
      • Galveston, Texas, United States, 77555-0371
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77024
      • Temple, Texas, United States, 76508
    • Utah
      • Layton, Utah, United States, 84041
    • Virginia
      • Norfolk, Virginia, United States, 23510
      • Richmond, Virginia, United States, 23298
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ciprofloxacin
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Drug: Ciprofloxacin
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Active Comparator: Non-quinolone antibiotic
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Drug: Non-quinolone antibiotic
Common used dose and route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
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.
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100201
  • 2014-004622-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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