Trial Outcomes & Findings for The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery (NCT NCT01464840)
NCT ID: NCT01464840
Last Updated: 2017-05-11
Results Overview
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.
COMPLETED
30 participants
48 hours after delivery
2017-05-11
Participant Flow
Patients were recruited from the prenatal clinic from May 2012 to May 2013.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
Baseline characteristics by cohort
| Measure |
15 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
30 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
60 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
27 years
STANDARD_DEVIATION 4 • n=99 Participants
|
27 years
STANDARD_DEVIATION 5 • n=107 Participants
|
29 years
STANDARD_DEVIATION 6 • n=206 Participants
|
28 years
STANDARD_DEVIATION 5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 48 hours after deliveryPopulation: No patients had azithromycin concentrations at least equivalent to the MIC 90.
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.
Outcome measures
| Measure |
30 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
15 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
60 Minutes
n=10 Participants
500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour
|
|---|---|---|---|
|
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
|
0 number of participants
|
0 number of participants
|
0 number of participants
|
Adverse Events
15 Minutes
30 Minutes
60 Minutes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amelia Sutton, M.D., Ph.D.
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place