Azithromycin for Premature Birth
(ALEC Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken indomethacin or any antibiotics in the 7 days before joining the study.
What data supports the effectiveness of the drug azithromycin for preventing premature birth?
Is azithromycin generally safe for humans?
How is the drug azithromycin unique for preventing premature birth?
Azithromycin is unique because it is easier to administer, has a better side effect profile, and is less expensive compared to erythromycin, which is often used for similar conditions. Additionally, azithromycin has strong anti-inflammatory properties and is effective against certain infections, which may help improve outcomes in preterm infants.36111213
What is the purpose of this trial?
Azithromycin is an antibiotic that is effective against bacteria that been associated with preterm birth (PTB). The purpose of this study is to evaluate if the addition of azithromycin prior to exam indicated cerclage prolongs gestation. A cerclage is a suture placed in the cervix to prolong gestation.
Research Team
Rupsa C Boelig, MD
Principal Investigator
Thomas Jefferson University
Jenani S Jayakumaran, MD
Principal Investigator
Thomas Jefferson University
Eligibility Criteria
This trial is for pregnant women over 18 years old with a single pregnancy, less than 24 weeks along, who need a cerclage (a stitch to keep the cervix closed). Participants must understand and agree to the study's procedures. Those with HIV, certain heart conditions, major fetal anomalies, fever, previous cerclage in current pregnancy or recent use of indomethacin/antibiotics cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive azithromycin, cefazolin, and indomethacin perioperatively with cerclage placement
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cervicovaginal cytokine analysis and neonatal outcomes
Treatment Details
Interventions
- Azithromycin
Azithromycin is already approved in European Union, United States, Canada for the following indications:
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor