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Levofloxacin Pharmacokinetics (PK) in the Severely Obese

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by (Responsible Party):
Scott Morehead, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00176306
First received: September 12, 2005
Last updated: September 12, 2012
Last verified: September 2012
Results First Received: August 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obesity
Critical Illness
Intervention: Drug: Levofloxacin 750 mg IV

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levofloxacin Arm Patients receive commercially available levofloxacin 750mg solution for intravnous use

Participant Flow:   Overall Study
    Levofloxacin Arm  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levofloxacin Arm patients receiving levofloxacin

Baseline Measures
    Levofloxacin Arm  
Number of Participants  
[units: participants]
  15  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.4  ± 12.8  
Gender  
[units: participants]
 
Female     7  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures

1.  Primary:   Area Under the Curve   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 number of ambulatory volunteers was low The acutely ill cohort was a heterogeneous population We remain unable to predict the precise effect of all of these different physiologic processes on drug pharmacokinetics


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Aaron Cook
Organization: University of Kentucky
phone: 8593239258
e-mail: amcook0@email.uky.edu


No publications provided


Responsible Party: Scott Morehead, University of Kentucky
ClinicalTrials.gov Identifier: NCT00176306     History of Changes
Other Study ID Numbers: CAPSS-391, CAPSS-391
Study First Received: September 12, 2005
Results First Received: August 2, 2011
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board