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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1029

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings