The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amelia Sutton, MD, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01464840
First received: October 26, 2011
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: November 2, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Endometritis
Intervention: Drug: Azithromycin

  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
Patients were recruited from the prenatal clinic from May 2012 to May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A.

Reporting Groups
  Description
15 Minutes

500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour

30 Minutes

500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour

60 Minutes

500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour


Participant Flow:   Overall Study
    15 Minutes     30 Minutes     60 Minutes  
STARTED     10     10     10  
COMPLETED     10     10     10  
NOT COMPLETED     0     0     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
15 Minutes

500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour

30 Minutes

500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour

60 Minutes

500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.

Azithromycin : 500 mg intravenous infused over 1 hour

Total Total of all reporting groups

Baseline Measures
    15 Minutes     30 Minutes     60 Minutes     Total  
Number of Participants  
[units: participants]
  10     10     10     30  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     10     10     30  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  27  ± 4     27  ± 5     29  ± 6     28  ± 5  
Gender  
[units: participants]
       
Female     10     10     10     30  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     10     10     10     30  



  Outcome Measures

1.  Primary:   Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration   [ Time Frame: 48 hours after delivery ]


  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
No text entered.


  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: Amelia Sutton, M.D., Ph.D.
Organization: University of Alabama at Birmingham
phone: 205-934-5612
e-mail: alsutton@uab.edu


No publications provided


Responsible Party: Amelia Sutton, MD, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01464840     History of Changes
Other Study ID Numbers: F101111007
Study First Received: October 26, 2011
Results First Received: November 2, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration