Extended Azithromycin Treatment in Prelabor Rupture of Membranes

NCT07669207 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY25110085
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age. Researchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin. Participants will:

• Be randomly assigned to one of two groups:
• The standard antibiotic treatment
• The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.
• Participants will be asked to complete a survey regarding their experience and side effects.

Conditions

Preterm Prelabor Rupture of Membranes; PPROM

Keywords

azithromycin; peri-viability

Outcome Measures

Primary Outcomes (11)

• Recruitment Capability

  Number of participants recruited per week/month

  From recruitment to enrollment, up to 3 days.

• Participant Eligibility

  Percentage of eligible participants who agree to participate, reasons for refusal or ineligibility

  From recruitment until enrollment, up to 3 days.

• Retention and Dropout Rates

  Percentage of patients who complete study and reasons for withdrawal from study.

  From recruitment to completion of the study, up to 4 months.

• Intervention Delivery

  Percentage of interventions delivered as intended

  From recruitment to completion of intervention, up to 15 days.

• Participant Acceptability

  Likert-scale survey evaluating the participant's perceived affective attitude, burden, ethicality, intervention coherence, confidence, opportunity costs, general acceptability, and side effects related to the study.

  At completion of study (either after Day 14 of study or after delivery if does not complete study) prior to hospital discharge.

• Data Collection Procedures

  Data completeness measured as number of participants with complete data entry.

  From recruitment to completion of postpartum period, up to 6 months.

• Resource Use and Cost

  Total cost versus planned budget, time and staffing required.

  From recruitment to postpartum period, up to 6 months.

• Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

  Adverse events associated with antibiotic usage, maternal and neonatal outcomes, bacterial resistance profiles. Assessed using previously validated Medication Side Effect survey.

  Ongoing during treatment from Day 2 through Day 14. Formally assessed with surveys as above on Day 8 and Day 14 (or earlier if delivers prior to completion of study period).

• Protocol Deviations

  Incidence of protocol deviation, indications for protocol deviation.

  From recruitment to completion of intervention, up to 15 days.

• Time for Delivery

  Amount of study team time needed for delivery.

  From recruitment to completion of postpartum period, up to 6 months.

• Financial Resources

  Amount of monetary resources needed for study delivery.

  From recruitment to postpartum period, up to 6 months.

Secondary Outcomes (24)

• Pregnancy Latency

  From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.

• Pregnancy Outcome

  From time of PPROM diagnosis (D0) until day of delivery, up to 3 months.

• NICU Admission

  From day of delivery through neonatal discharge, up to 4 months.

• Neonatal Ventilatory Support

  From day of delivery through neonatal discharge, up to 4 months.

• Neonatal Sepsis

  From day of delivery through neonatal discharge, up to 4 months.

Study Arms (2)

Standard Antibiotic Regimen

ACTIVE COMPARATOR

A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.

Drug: Standard Azithromycin Dosing

Extended Azithromycin Regimen

EXPERIMENTAL

The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.

Drug: Azithromycin (Azithro); Drug: Standard Azithromycin Dosing

Interventions

Azithromycin (Azithro) DRUG

Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.

Extended Azithromycin Regimen

Standard Azithromycin Dosing DRUG

Oral Azithromycin 1g once.

Extended Azithromycin Regimen; Standard Antibiotic Regimen

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation
• Gestational age at time of PPROM between 22w0d and 28w0d
• Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)
• Remain pregnant 48 hours after presentation.
• Patients who receive betamethasone, magnesium therapy, and/or a limited course of tocolysis (through the betamethasone window) will be included.
• Pregnant patients below the age of 18 are eligible.

You may not qualify if:

• Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)
• Lethal congenital defects
• Multiple gestation
• Ongoing alternative antibiotic treatment
• Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic
• History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin
• Known prolongation of QT interval
• History of torsades de pointes
• Congenital long QT syndrome
• Bradyarrhythmia
• Decompensated heart failure
• Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents
• Impaired hepatic function
• GFR\<10 mL/min
• Diagnosis of myasthenia gravis

Sponsors & Collaborators

• Alexa Henderson: lead

Study Sites (1)

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15217, United States

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Christina Megli, MD/PhD

  University of Pittsburgh Magee-Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Henderson, MD

CONTACT

9136019107; hendersona8@upmc.edu

Christina Megli, MD, PhD

CONTACT

meglicj@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication without end.
• Access Criteria: Collaborating principal investigators will have access to IPD. The information will be shared upon request via secure email or to advance further research efforts in the case of a multi-site trial.

Locations

US (1)