50 Participants Needed

Azithromycin for Premature Birth

(ALEC Trial)

Recruiting at 1 trial location
JS
RB
Overseen ByRupsa Boelig, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Thomas Jefferson University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that azithromycin can improve birth weight and gestational age at birth, reduce neonatal infections, and delay preterm delivery in certain settings. It is also effective against infections like Ureaplasma, which are linked to preterm birth.12345

Is azithromycin generally safe for humans?

Azithromycin is generally considered safe for humans, with common side effects like diarrhea and abdominal pain being mild or moderate. Serious side effects are rare, occurring in less than one percent of patients, and it is well tolerated across various ages and conditions.678910

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 | Jefferson Health

Rupsa C Boelig, MD

Principal Investigator

Thomas Jefferson University

JS

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

Pregnant women with singleton pregnancies
I am eligible for a stitch to prevent premature birth.
I understand the study's purpose and agree to follow its protocol.
See 1 more

Exclusion Criteria

I have a diagnosed heart condition that affects my heart's electrical activity.
I have not taken indomethacin or antibiotics in the last 7 days.
Allergy to both penicillin and clindamycin
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive azithromycin, cefazolin, and indomethacin perioperatively with cerclage placement

26 weeks
Regular visits for medication administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cervicovaginal cytokine analysis and neonatal outcomes

4 weeks
1-2 visits (in-person)

Treatment Details

Interventions

  • Azithromycin
Trial Overview 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.
Participant Groups
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

Azithromycin is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Azithromycin for:
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Sexually transmitted diseases
  • Toxoplasmosis
  • Malaria
  • Preterm prelabor rupture of membranes
🇺🇸
Approved in United States as Azithromycin for:
  • Respiratory tract infections
  • Skin and soft tissue infections
  • Sexually transmitted diseases
  • Toxoplasmosis
  • Malaria
  • Preterm prelabor rupture of membranes
🇨🇦
Approved in Canada as Azithromycin for:
  • 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

Trials
475
Recruited
189,000+

Findings from Research

The SANTE trial, involving 49,600 pregnant women and their infants in rural Mali, aims to evaluate the effectiveness of azithromycin in preventing stillbirths and infant mortality over 6-12 months, using a randomized, placebo-controlled design.
The study will also assess the impact of administering azithromycin alongside routine vaccinations (Penta-1 and Penta-3) on infant survival, potentially influencing future healthcare guidelines for antenatal and infant care.
Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2×2 factorial randomised controlled trial in Mali.Driscoll, AJ., Haidara, FC., Tapia, MD., et al.[2023]
Azithromycin has been shown to be more effective than placebo in eradicating Ureaplasma in preterm neonates, based on a review of 9 studies involving 388 neonates.
Despite its efficacy in Ureaplasma eradication, azithromycin did not significantly reduce the incidence of bronchopulmonary dysplasia (BPD) compared to placebo, and no serious adverse effects were reported.
Azithromycin for Eradication of Ureaplasma and Prevention of Bronchopulmonary Dysplasia in Preterm Neonates in the Neonatal Intensive Care Unit.Chang, E., Ballard, KE., Johnson, PN., et al.[2023]
The AZTEC trial is a large-scale study involving 796 infants born before 30 weeks' gestation, aiming to determine if a 10-day course of intravenous azithromycin can reduce the rates of chronic lung disease of prematurity (CLD) compared to a placebo.
Azithromycin is expected to improve respiratory outcomes by targeting both Ureaplasma infections and inflammation, with secondary outcomes including monitoring for potential adverse effects and other complications like necrotizing enterocolitis and retinopathy of prematurity.
Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) - a randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants.Lowe, J., Gillespie, D., Hubbard, M., et al.[2021]

References

Antenatal, intrapartum and infant azithromycin to prevent stillbirths and infant deaths: study protocol for SANTE, a 2×2 factorial randomised controlled trial in Mali. [2023]
Azithromycin for Eradication of Ureaplasma and Prevention of Bronchopulmonary Dysplasia in Preterm Neonates in the Neonatal Intensive Care Unit. [2023]
Study protocol: azithromycin therapy for chronic lung disease of prematurity (AZTEC) - a randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants. [2021]
The APPLe study: a randomized, community-based, placebo-controlled trial of azithromycin for the prevention of preterm birth, with meta-analysis. [2022]
Maternal azithromycin therapy for Ureaplasma intraamniotic infection delays preterm delivery and reduces fetal lung injury in a primate model. [2021]
Use and safety of azithromycin in neonates: a systematic review. [2022]
Clinical toleration and safety of azithromycin. [2022]
Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis. [2022]
Azithromycin induced hepatocellular toxicity and hepatic encephalopathy in asymptomatic dilated cardiomyopathy. [2021]
Pregnancy outcome following gestational exposure to azithromycin. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Azithromycin vs erythromycin for the management of preterm premature rupture of membranes. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Azithromycin for preventing bronchopulmonary dysplasia in preterm infants: A systematic review and meta-analysis. [2021]
[Pharmacological and pharmacokinetic properties of azithromycin (Zithromac), a novel 15-membered ring macrolide antibacterial agent]. [2019]
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