PKAZ: The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT01464840
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis.

Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.

Condition or Disease	Intervention/Treatment	Phase
Endometritis	Drug: Azithromycin

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
15 minutes 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.	Drug: Azithromycin; 500 mg intravenous infused over 1 hour; Other Names: Zmax
30 minutes 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.	Drug: Azithromycin; 500 mg intravenous infused over 1 hour; Other Names: Zmax
60 minutes 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.	Drug: Azithromycin; 500 mg intravenous infused over 1 hour; Other Names: Zmax

Outcome Measures

Primary Outcome Measures

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

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Women 19 years and older

• Term (37 weeks and greater)

• Singleton gestation

• Scheduled cesarean section

• Non-laboring

• Intact membranes

Exclusion Criteria:

• < 19 years of age

• Preterm (< 37 weeks)

• Multifetal gestation

• Laboring or ruptured membranes

• Known fetal anomaly

• Oligo- or polyhydramnios

• Macrolide allergy

• Macrolide exposure within 2 weeks

• Medical co-morbidities

• Hepatic or renal impairment

• Taking medications that prolong the QT interval

• Currently taking nelfinavir, efavirenz, or flucanozole

• Structural heart defects or arrythmia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Amelia L Sutton, M.D., Ph.D., University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amelia Sutton, MD, PhD, Fellow/Instructor, Maternal Fetal Medicine, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01464840
• Other Study ID Numbers: F101111007
• First Posted: Nov 4, 2011
• Last Update Posted: May 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Amelia Sutton, MD, PhD, Fellow/Instructor, Maternal Fetal Medicine, University of Alabama at Birmingham: Pregnancy; Cesarean section; Antibiotic
• Additional relevant MeSH terms: Endometritis; Azithromycin

Study Results

Participant Flow

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

Arm/Group Title	15 Minutes	30 Minutes	60 Minutes
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

Baseline Characteristics

Arm/Group Title	15 Minutes	30 Minutes	60 Minutes	Total
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 Participants	10	10	10	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	10 100%	30 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (4)	27 (5)	29 (6)	28 (5)
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	10 100%	30 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	10 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
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

Outcome Measure Data

Analysis Population Description

No patients had azithromycin concentrations at least equivalent to the MIC 90.

Arm/Group Title	30 Minutes	15 Minutes	60 Minutes
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
Measure Participants	10	10	10
Number [number of participants]	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	15 Minutes		30 Minutes		60 Minutes
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	15 Minutes		30 Minutes		60 Minutes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	15 Minutes		30 Minutes		60 Minutes
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.