Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

NCT06396078 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024H0122
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.

Conditions

Preterm Premature Rupture of Membrane; Pregnancy, High Risk; Preterm Birth

Keywords

Pregnancy; Preterm premature rupture of membranes; Latency; Chorioamnionitis; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Latency

  Latency will be measured in hours, and also reported as days for clinical interpretability.

  From randomization to delivery

Secondary Outcomes (8)

• Neonatal outcome composite checklist

  From birth to up to 6 weeks postpartum

• Endometritis

  From birth to up to 6 weeks postpartum

• Surgical site infection

  From birth to up to 6 weeks postpartum

• Individual clinical infections

  From birth to up to 6 weeks postpartum

• Puerperal fever

  From birth to up to 6 weeks postpartum

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants randomized to the intervention group will receive the following regimen: * Ceftriaxone 1 g IV q 24 hours x 7 days * Clarithromycin 500 mg PO BID x 7 days * Metronidazole 500 mg PO q 12 hours x 7 days

Drug: Ceftriaxone 1000 MG; Drug: Clarithromycin 500mg; Drug: Metronidazole 500 mg

Standard of care

OTHER

Participants randomized to the standard care group will receive the following regimen: * Ampicillin 2 g IV q 6 hours x 48 hours followed by amoxicillin 250 mg q 8 hours for an additional 5 days * Azithromycin 1 g PO x 1 dose OR erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days

Drug: Ampicillin 2 GM Injection; Drug: Amoxicillin 250 MG; Drug: Azithromycin; Drug: Erythromycin

Interventions

Ceftriaxone 1000 MG DRUG

Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)

Intervention group

Clarithromycin 500mg DRUG

Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)

Intervention group

Metronidazole 500 mg DRUG

Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)

Intervention group

Ampicillin 2 GM Injection DRUG

Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)

Standard of care

Amoxicillin 250 MG DRUG

Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)

Standard of care

Azithromycin DRUG

Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)

Standard of care

Erythromycin DRUG

Erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days (in addition to ampicillin and amoxicillin)

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study is restricted to pregnant individuals.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the inpatient unit for expectant management of PPROM until delivery
• Age ≥ 18 years with the ability to provide informed consent
• Gestational age between 23 0/7 and 32 6/7 weeks

You may not qualify if:

• Having received more than one dose of any prophylactic antibiotic
• Suspected or confirmed infection requiring treatment with antibiotics
• Allergy or contraindication to an antibiotic in either arm
• Maternal immunosuppression

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (2)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 775555, United States

RECRUITING

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Premature Birth; Chorioamnionitis

Interventions

Ceftriaxone; Clarithromycin; Metronidazole; Amoxicillin; Azithromycin; Erythromycin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Fetal Membranes, Premature Rupture; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Ampicillin; Penicillin G; Penicillins

Study Officials

• Marissa Berry, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Kartik K Venkatesh, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marissa Berry, MD

CONTACT

614-293-4780; Marissa.Berry@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: July 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)