Endometritis
Conditions
Keywords
Pregnancy, Cesarean section, Antibiotic
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.
Interventions
DRUGAzithromycin
500 mg intravenous infused over 1 hour
Sponsors
University of Alabama at Birmingham
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the prenatal clinic from May 2012 to May 2013.
Participants by arm
| Arm | Count |
|---|---|
| 15 Minutes 500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour | 10 |
| 30 Minutes 500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour | 10 |
| 60 Minutes 500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.
Azithromycin : 500 mg intravenous infused over 1 hour | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | 30 Minutes | 60 Minutes | 15 Minutes | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Age, Continuous | 27 years STANDARD_DEVIATION 5 | 29 years STANDARD_DEVIATION 6 | 27 years STANDARD_DEVIATION 4 | 28 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration
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
Population: No patients had azithromycin concentrations at least equivalent to the MIC 90.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 30 Minutes | Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration | 0 number of participants |
| 15 Minutes | Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration | 0 number of participants |
| 60 Minutes | Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration | 0 number of participants |