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BAY 0 9867 Cipro Pediatric Use Study (QUIP)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00761462
First received: September 26, 2008
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
Results First Received: December 19, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Infectious Diseases
Interventions: Drug: Ciprofloxacin
Drug: Non-quinolone antibiotic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Observational study in which patients were recruited between 1999 and 2002, and followed up for 5 years (ciprofloxacin patients) or 2 years (non-ciprofloxacin patients), monitoring the occurrence of musculoskeletal and central nervous system events.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The decision to treat with ciprofloxacin or a non-quinolone antibiotic was made prior to a patient's enrollment in the study and was based on the particular infection, type of patient, medical history, and the clinical evaluation by the prescribing physician. The study was not randomized.

Reporting Groups
  Description
Ciprofloxacin Subjects receiving Ciprofloxacin (group followed-up for 5 years)
Non-quinolone Antibiotic Subjects receiving non-quinolone antibiotic (group followed-up for 2 years)

Participant Flow for 2 periods

 Period 1:   Treatment
    Ciprofloxacin     Non-quinolone Antibiotic  
STARTED     510 [1]   519 [1]
COMPLETED     487 [2]   507 [2]
NOT COMPLETED     23     12  
Subjects never received study medication                 23                 12  
[1] Patients enrolled in study group
[2] Patients with confirmed intake of study drug

Period 2:   2 or 5 Years Long-term Safety Follow-up
    Ciprofloxacin     Non-quinolone Antibiotic  
STARTED     487 [1]   507 [1]
4-6 Weeks Post Treatment     487     507  
1 Year Follow-up     485     507  
COMPLETED     333 [2]   456 [3]
NOT COMPLETED     154     51  
Death                 4                 0  
Lost to Follow-up                 75                 30  
Withdrawal by Subject                 75                 21  
[1] Patients with confirmed intake of study drug entering long-term safety evaluation
[2] Patients under safety evaluation at end of 5 year safety Follow-up.
[3] Patients under safety evaluation at end of 2 year safety Follow-up.



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Incidence of Arthropathy (Cumulative)   [ Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment ]
  Show Outcome Measure 1

2.  Primary:   Incidence of Nervous System Events (Cumulative)   [ Time Frame: 4-6 weeks after treatment / 1 year after treatment / 2 or 5 years after treatment ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00761462     History of Changes
Other Study ID Numbers: 100201
Study First Received: September 26, 2008
Results First Received: December 19, 2008
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration