BAY 0 9867 Cipro Pediatric Use Study (QUIP)

NCT00761462 | Completed Phase 3 Results DMC

• 2 other identifiers: 1002012014-004622-18
• Study Type: interventional
• Target: 1,029
• Locations: 2 countries
• Sites: 67

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.

Conditions

Infectious Diseases

Keywords

Pediatrics; Safety; Musculoskeletal System; Neurologic Manifestations; Joint Diseases; Joint Deformities, Acquired

Outcome Measures

Primary Outcomes (2)

• 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.

  4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

• 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.

  4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment

Study Arms (2)

Ciprofloxacin

EXPERIMENTAL

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

Drug: Ciprofloxacin

Non-quinolone antibiotic

ACTIVE COMPARATOR

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

Drug: Non-quinolone antibiotic

Interventions

Ciprofloxacin DRUG

Either as oral suspension, oral tablets or sequential intravenous (IV) - oral therapy or purely IV therapy according to label

Ciprofloxacin

Non-quinolone antibiotic DRUG

Common used dose and route

Non-quinolone antibiotic

Eligibility Criteria

• Age: 2 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (67)

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Mobile, Alabama, 36608, United States

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Fort Smith, Arkansas, 72903, United States

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Corona, California, 92879, United States

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Fountain Valley, California, 92708, United States

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Long Beach, California, 90806, United States

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Orange, California, 92868-3974, United States

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Pico Rivera, California, 90660, United States

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San Bernardino, California, 92411, United States

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San Luis Obispo, California, 93405, United States

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Centennial, Colorado, 80112, United States

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Denver, Colorado, 80218, United States

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Fort Walton Beach, Florida, 32548, United States

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Gainesville, Florida, 32610-0254, United States

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Hialeah, Florida, 33013, United States

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Jacksonville, Florida, 32209, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33155, United States

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Pensacola, Florida, 32504, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33607, United States

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Snellville, Georgia, 30078, United States

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Honolulu, Hawaii, 96813, United States

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Idaho Falls, Idaho, 83404, United States

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Park Ridge, Illinois, 60068-1174, United States

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Springfield, Illinois, 62701, United States

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Indianapolis, Indiana, 46202, United States

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Overland Park, Kansas, 66215, United States

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Bardstown, Kentucky, 40004, United States

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New Orleans, Louisiana, 70118-5799, United States

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Boston, Massachusetts, 02115, United States

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Red Wing, Minnesota, 55066-0095, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89109, United States

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Hackensack, New Jersey, 07601-1991, United States

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Voorhees Township, New Jersey, 08043, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10021-4885, United States

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New York, New York, 10032, United States

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Stony Brook, New York, 11794-8111, United States

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The Bronx, New York, 10461, United States

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Durham, North Carolina, 27710, United States

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Wilmington, North Carolina, 28401, United States

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Akron, Ohio, 44308-1062, United States

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Cleveland, Ohio, 44109-1998, United States

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Dayton, Ohio, 45404-1815, United States

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Youngstown, Ohio, 44501-0240, United States

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Oklahoma City, Oklahoma, 73104, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74135, United States

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Elverson, Pennsylvania, 19520, United States

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Havertown, Pennsylvania, 19083, United States

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Charleston, South Carolina, 29425, United States

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Memphis, Tennessee, 38105-2729, United States

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Austin, Texas, 78756, United States

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Benbrook, Texas, 76126, United States

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El Paso, Texas, 79925, United States

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Fort Worth, Texas, 76104, United States

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Galveston, Texas, 77555-0371, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77030, United States

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Temple, Texas, 76508, United States

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Layton, Utah, 84041, United States

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Norfolk, Virginia, 23510, United States

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Richmond, Virginia, 23298, United States

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Morgantown, West Virginia, 26506, United States

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Montreal, Quebec, H3H 1P3, Canada

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Communicable Diseases; Neurologic Manifestations; Joint Diseases; Joint Deformities, Acquired

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Signs and Symptoms; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was not randomized or blinded; the demographic and baseline infection characteristics were not comparable for the treatment groups; the long term followup times were different for the two groups (5 year versus 2 years).

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 29, 2008
• Study Start: October 1, 1999
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 31, 2015
• Results First Posted: April 14, 2009

Record last verified: 2015-07

Locations

US (66); CA (1)