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Macrolide Antibiotic

Azithromycin for Premature Birth (ALEC Trial)

Phase 4

Recruiting

Led By Rupsa Boelig, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet criteria for an exam indicated cerclage

≥18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 28 days of delivery

Awards & highlights

ALEC Trial Summary

This trial is testing whether the antibiotic azithromycin, given before a cerclage is placed, can prolong gestation.

Who is the study for?

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.Check my eligibility

What is being tested?

The study tests if adding azithromycin (an antibiotic) before placing a cervical stitch can extend pregnancy duration and prevent premature birth. It compares outcomes between standard treatment with cefazolin and indomethacin versus the addition of azithromycin.See study design

What are the potential side effects?

Azithromycin may cause stomach upset, diarrhea, allergic reactions or changes in taste. Cefazolin could lead to rash, pain at injection site or rarely serious allergic reactions. Indomethacin might result in nausea, heartburn or headache.

ALEC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for a stitch to prevent premature birth.

Select...

I am 18 years old or older.

ALEC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 28 days of delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 28 days of delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 28 days of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gestational Latency Achieved Between Cerclage Placement and Time of Delivery

Secondary outcome measures

Admission to neonatal intensive care unit

Cervicovaginal cytokine analysis

Mean gestational age at delivery

+4 more

ALEC Trial Design

2Treatment groups

Experimental Treatment

Group I: Cefazolin and IndomethacinExperimental Treatment1 Intervention

Control arm- perioperative cefazolin and indomethacin

Group II: Azithromycin + controlExperimental Treatment2 Interventions

perioperative azithromycin, cefazolin and indomethacin

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,439 Total Patients Enrolled

Rupsa Boelig, MDPrincipal InvestigatorThomas Jefferson University

Jenani S Jayakumaran, MDPrincipal InvestigatorThomas Jefferson University

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05132829 — Phase 4

Uterine Cervical Insufficiency Research Study Groups: Azithromycin + control, Cefazolin and Indomethacin

Uterine Cervical Insufficiency Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT05132829 — Phase 4

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132829 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research open to participants aged sixty and above?

"The minimum age for participation in this trial is 18 and the upper limit of enrolment is set at 80."

Answered by AI

Have Cefazolin and indomethacin been granted regulatory approval by the FDA?

"Our assessment of Cefazolin and indomethacin's safety is a 3 on the 1-3 scale, as this medication has already been approved by Phase 4 trials."

Answered by AI

To what pathologies are Cefazolin and Indomethacin typically prescribed?

"Cefazolin and indomethacin are both recommended as therapeutic options for patients undergoing surgical prophylaxis, those with an inadequate response to conventional treatments, or individuals suffering from chlamydia infections."

Answered by AI

Are there any other published studies that have explored the interaction between Cefazolin and indomethacin?

"Cefazolin and indomethacin were first investigated at Vanderbilt University's Autonomic Dysfunction Centre in 1997. Now, there are 351 completed studies associated with this trial drug combination, including 84 live trials conducted mainly from Chicago, Illinois."

Answered by AI

To whom is enrollment in this experiment open?

"To be considered for this clinical experiment, candidates must demonstrate evidence of substance abuse and fall within the 18-80 year old age bracket. Altogether 50 volunteers are required to participate in this research endeavour."

Answered by AI

Is enrollment available for this experiment at present?

"Data hosted on clinicaltrials.gov states that this medical experiment is seeking volunteers. The study was first made public on December 20th 2021 and had its most recent modification take place on February 28th 2022."

Answered by AI

What is the current enrollment count for this medical study?

"Affirmative. Clinicaltrials.gov provides evidence that this research project, which was originally posted on December 20th 2021, is still actively seeking participants. 50 individuals must be selected from 2 distinct medical facilities for the purposes of this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial

2021. "Azithromycin to Improve Latency in Exam Indicated Cerclage Control Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132829.

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