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Macrolide Antibiotic

Azithromycin for Reducing Infections After C-Section (PRECEDE Trial)

Phase 3

Recruiting

Led By Rebecca G Clifton, PhD

Research Sponsored by The George Washington University Biostatistics Center

Eligibility Criteria Checklist

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

Must have

≥ 23 weeks' gestation (ACOG dating criteria)

Must not have

Azithromycin treatment within 7 days

Premature rupture of membranes (PROM) or labor (i.e., contractions with ongoing cervical change)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivery to hospital discharge (up to 120 days)

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether giving azithromycin along with standard antibiotics to 8,000 women having a cesarean delivery can help reduce infections after childbirth. The study will compare the rates of

Who is the study for?

This trial is for individuals scheduled for a cesarean delivery (C-section) without labor. Participants must be willing to take additional medication or placebo alongside standard preoperative antibiotics and can't have conditions that exclude them from the study.

What is being tested?

The trial tests if adding azithromycin to usual pre-surgery antibiotics reduces postpartum infections in those having C-sections. It's a large study where participants are randomly given either azithromycin or a placebo, without knowing which one they receive.

What are the potential side effects?

Azithromycin may cause side effects like diarrhea, nausea, abdominal pain, and allergic reactions. However, specific side effects related to this trial setting will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

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

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I am at least 23 weeks pregnant according to ACOG guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken azithromycin in the last 7 days.

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My water has broken or I am in labor.

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I have experienced a fetal loss or my baby has a significant birth defect.

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I am not allergic to azithromycin or similar antibiotics, and have never had liver issues with them.

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I am on antibiotics for a bacterial infection after giving birth.

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I will be taking antibiotics after delivery for prevention.

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I do not have heart disease or a weak heart (ejection fraction is 40% or higher).

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I have a heart rhythm problem or take medication that affects my heart's rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delivery to hospital discharge (up to 120 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delivery to hospital discharge (up to 120 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and delivery to hospital discharge (up to 120 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maternal infection composite

Secondary study objectives

Maternal Hospital Length of Stay

Maternal Resource Composite

Neonatal Resource Composite

+8 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Azithromycin prophylaxis and standard of care preoperative antibioticsExperimental Treatment2 Interventions

500mg of intravenous azithromycin administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour per FDA infusion recommendations for azithromycin. Additionally patients will received standard of care preoperative antibiotics (excluding azithromycin) prior to incision.

Group II: Placebo and standard of care preoperative antibioticsPlacebo Group2 Interventions

Normal saline administered up to 1 hour prior to cesarean incision (or as soon as feasible after incision) and infused over one hour in addition to standard of care preoperative antibiotics (excluding azithromycin) prior to incision.

0 / 9Eligibility criteria met