Recruiting

Antibiotic Treatment vs. Azithromycin

Sponsor:

Alexa Henderson

Code:

NCT07669207

Conditions

Preterm Prelabor Rupture of Membranes

PPROM

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Azithromycin (Azithro)

Standard Azithromycin Dosing

Study Details

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

Study ID

NCT07669207

Start date

Aug 19, 2026

Status verified date

Sep, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Antibiotic Regimen

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.

experimental: Extended Azithromycin Regimen

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

Interventions

Azithromycin (Azithro)

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

Standard Azithromycin Dosing

Oral Azithromycin 1g once.

Primary outcome measure

  • Recruitment Capability [ Time Frame: From recruitment to enrollment, up to 3 days. ]
  • Participant Eligibility [ Time Frame: From recruitment until enrollment, up to 3 days. ]
  • Retention and Dropout Rates [ Time Frame: From recruitment to completion of the study, up to 4 months. ]
  • Intervention Delivery [ Time Frame: From recruitment to completion of intervention, up to 15 days. ]
  • Participant Acceptability [ Time Frame: 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 [ Time Frame: From recruitment to completion of postpartum period, up to 6 months. ]
  • Resource Use and Cost [ Time Frame: From recruitment to postpartum period, up to 6 months. ]
  • Incidence of Treatment-Related Adverse Events [Safety and Tolerability] [ Time Frame: 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 [ Time Frame: From recruitment to completion of intervention, up to 15 days. ]
  • Time for Delivery [ Time Frame: From recruitment to completion of postpartum period, up to 6 months. ]
  • Financial Resources [ Time Frame: From recruitment to postpartum period, up to 6 months. ]

Central Contacts and Locations

Central contacts

Alexa Henderson, MD

9136019107hendersona8@upmc.edu

Christina Megli, MD, PhD

meglicj@upmc.edu

Locations

University of Pittsburgh Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15217

Contacts

Alexa Henderson, MD

9136019107hendersona8@upmc.edu

Christina Megli, MD, PhD

meglicj@upmc.edu

Principal Investigator:

Christina Megli, MD, PhD

More Information

Sponsor

Alexa Henderson

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • azithromycin
  • peri-viability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexa Henderson on 2026-09-04.