N/A
Completed N=30
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery
Source: ClinicalTrials.gov NCT01464840 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration — 0; 0; 0 number of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration |
0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01464840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.