Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

NCT06273891 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: INOVA-2023-5823-08-WC-0198
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

Conditions

Premature Rupture of Membrane

Keywords

pprom; latency antibiotics; prom

Outcome Measures

Primary Outcomes (1)

• Latency period

  Time from PPROM to delivery between the two treatments

  Number of days from PPROM to delivery, assessed up to 105 days

Study Arms (2)

Erythromycin

ACTIVE COMPARATOR

Erythromycin 250 mg IV every 6 hours for 48 hours, followed by 250 mg PO or 333 mg PO every 8 hours for 5 days

Drug: Erythromycin

Azithromycin

ACTIVE COMPARATOR

Azithromycin 1 gm PO once or 500 mg PO followed by 250 mg PO daily for a total of 5 days

Drug: Azithromycin

Interventions

Erythromycin DRUG

Erythromycin 250 mg IV every 6 hours for 48 hours, followed by 250 mg PO or 333 mg PO every 8 hours for 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days

Erythromycin

Azithromycin DRUG

Azithromycin 1 gm PO once or 500 mg PO followed by 250 mg PO daily for a total of 5 days in addition to Ampicillin 2 gm IV every 6 hours for 2 days followed by Amoxicillin 250 mg PO every 8 hours for 5 days

Azithromycin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation.
• Rupture of membranes confirmed by biochemical testing.
• Membrane rupture within the past 36 hours.
• Cervical dilation 3 cm or less and 4 or fewer contractions within 60-minutes at the time of admission.
• Age ≥18 and \<50 years.

You may not qualify if:

• Non-reassuring fetal heart tracing, vaginal bleeding, chorioamnionitis or any indication for delivery at admission.
• Allergy to penicillin, erythromycin, or azithromycin.
• Multiple gestations.

Sponsors & Collaborators

• Inova Health Care Services: lead
• Eastern Virginia Medical School: collaborator

Study Sites (2)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

Eastern Viriginia Medical School

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (3)

• Navathe R, Schoen CN, Heidari P, Bachilova S, Ward A, Tepper J, Visintainer P, Hoffman MK, Smith S, Berghella V, Roman A. Azithromycin vs erythromycin for the management of preterm premature rupture of membranes. Am J Obstet Gynecol. 2019 Aug;221(2):144.e1-144.e8. doi: 10.1016/j.ajog.2019.03.009. Epub 2019 Mar 20.

  PMID: 30904320 BACKGROUND

• Drassinower D, Friedman AM, Obican SG, Levin H, Gyamfi-Bannerman C. Prolonged latency of preterm prelabour rupture of membranes and neurodevelopmental outcomes: a secondary analysis. BJOG. 2016 Sep;123(10):1629-35. doi: 10.1111/1471-0528.14133. Epub 2016 May 31.

  PMID: 27245741 BACKGROUND

• Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.

  PMID: 32080050 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Preterm Premature Rupture of the Membranes

Interventions

Erythromycin; Azithromycin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Antonio Saad, MD, MBA

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Saad, MD, MBA

CONTACT

7037766040; antonio.saad@inova.org

Ellen M Murrin, DO

CONTACT

7037766040; ellen.murrin@inova.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 23, 2024
• Study Start: March 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)