Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464840
Other study ID # F101111007
Secondary ID
Status Completed
Phase N/A
First received October 26, 2011
Last updated November 18, 2013
Start date November 2011
Est. completion date August 2013

Study information

Verified date November 2013
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin
500 mg intravenous infused over 1 hour

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 48 hours after delivery No
See also
  Status Clinical Trial Phase
Recruiting NCT05049395 - HFNO Reducing the Incidence of Hypoxia for Hysteroscopy Sedated With Propofol N/A
Terminated NCT00386477 - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial N/A
Terminated NCT04163679 - Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections N/A
Recruiting NCT03960970 - Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries Phase 2
Completed NCT03459599 - Antibiotic Prophylaxis in Ragged Placental Membranes N/A
Completed NCT01762098 - Chronic Endometritis in Patients With Recurrent Miscarriages or Repeated Implantation Failures in In-vitro Fertilization N/A
Withdrawn NCT01721616 - Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis Phase 4
Completed NCT01235546 - Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection N/A
Recruiting NCT04307069 - Management of Prelabor Rupture of the Membranes at Term N/A
Terminated NCT01587495 - Pharmacokinetics and Safety of Ertapenem in the Postpartum Period Phase 1
Completed NCT03442218 - Use of Antiseptic Solution for Vaginal Wash Before Cesarean Section N/A
Not yet recruiting NCT01945450 - Prophylactic Antibiotics for Manual Removal of Retained Placenta in Vaginal Birth: a Randomized Controlled Trial N/A
Completed NCT00547170 - Doxycycline Prophylaxis at Vacuum Aspiration Trial Phase 4
Completed NCT00501033 - A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter N/A
Completed NCT00500019 - Uterine Flora During Elective and Urgent Cesarean Sections N/A
Completed NCT00330278 - Timing of Prophylactic Antibiotics for Cesarean Sections N/A
Completed NCT00603603 - Controlled Clinical Trial of Supplemental Oxygen for the Prevention of Post-Cesarean Infectious Morbidity N/A
Completed NCT00858832 - Reduction of Endometritis After Cesarean Section With the Routine Use of Methergine N/A
Recruiting NCT04197167 - Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis N/A
Completed NCT02402907 - STRIPES Study: Study To Reduce Infection Post cEsarean Section N/A