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Trial record 15 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (PKAZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01464840
Recruitment Status : Completed
First Posted : November 4, 2011
Results First Posted : January 9, 2014
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Amelia Sutton, MD, PhD, University of Alabama at Birmingham

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Endometritis
Intervention Drug: Azithromycin
Enrollment 30
Recruitment Details Patients were recruited from the prenatal clinic from May 2012 to May 2013.
Pre-assignment Details  
Arm/Group Title 15 Minutes 30 Minutes 60 Minutes
Hide Arm/Group Description

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

Period Title: Overall Study
Started 10 10 10
Completed 10 10 10
Not Completed 0 0 0
Arm/Group Title 15 Minutes 30 Minutes 60 Minutes Total
Hide Arm/Group Description

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
27  (4) 27  (5) 29  (6) 28  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 30 participants
10 10 10 30
1.Primary Outcome
Title Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
Hide Description The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
No patients had azithromycin concentrations at least equivalent to the MIC 90.
Arm/Group Title 30 Minutes 15 Minutes 60 Minutes
Hide Arm/Group Description:

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

Overall Number of Participants Analyzed 10 10 10
Measure Type: Number
Unit of Measure: number of participants
0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 15 Minutes 30 Minutes 60 Minutes
Hide Arm/Group Description

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

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

Azithromycin : 500 mg intravenous infused over 1 hour

All-Cause Mortality
15 Minutes 30 Minutes 60 Minutes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
15 Minutes 30 Minutes 60 Minutes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
15 Minutes 30 Minutes 60 Minutes
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Amelia Sutton, M.D., Ph.D.
Organization: University of Alabama at Birmingham
Phone: 205-934-5612
EMail: alsutton@uab.edu
Layout table for additonal information
Responsible Party: Amelia Sutton, MD, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01464840     History of Changes
Other Study ID Numbers: F101111007
First Submitted: October 26, 2011
First Posted: November 4, 2011
Results First Submitted: November 2, 2013
Results First Posted: January 9, 2014
Last Update Posted: May 11, 2017