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BAY 0 9867 Cipro Pediatric Use Study (QUIP)

Primary Purpose

Infectious Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciprofloxacin
Non-quinolone antibiotic
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Diseases focused on measuring Pediatrics, Safety, Musculoskeletal System, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired

Eligibility Criteria

2 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ciprofloxacin

Non-quinolone antibiotic

Arm Description

Subjects receiving Ciprofloxacin (group followed-up for 5 years)

Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Outcomes

Primary Outcome Measures

Incidence of Arthropathy (Cumulative)
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.
Incidence of Nervous System Events (Cumulative)
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
July 13, 2015
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00761462
Brief Title
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

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diseases
Keywords
Pediatrics, Safety, Musculoskeletal System, Neurologic Manifestations, Joint Diseases, Joint Deformities, Acquired

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1029 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ciprofloxacin
Arm Type
Experimental
Arm Description
Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Arm Title
Non-quinolone antibiotic
Arm Type
Active Comparator
Arm Description
Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label
Intervention Type
Drug
Intervention Name(s)
Non-quinolone antibiotic
Intervention Description
Common used dose and route
Primary Outcome Measure Information:
Title
Incidence of Arthropathy (Cumulative)
Description
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.
Time Frame
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment
Title
Incidence of Nervous System Events (Cumulative)
Description
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.
Time Frame
4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868-3974
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92411
Country
United States
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93405
Country
United States
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
Ft. Walton Beach
State/Province
Florida
ZIP/Postal Code
32548
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0254
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118-5799
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Red Wing
State/Province
Minnesota
ZIP/Postal Code
55066-0095
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1991
Country
United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021-4885
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8111
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109-1998
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501-0240
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Elverson
State/Province
Pennsylvania
ZIP/Postal Code
19520
Country
United States
City
Havertown
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105-2729
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
City
Benbrook
State/Province
Texas
ZIP/Postal Code
76126
Country
United States
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0371
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

BAY 0 9867 Cipro Pediatric Use Study (QUIP)

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