Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)

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

Interventions

DRUG

Ceftriaxone 1000 MG

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

DRUG

Clarithromycin 500mg

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

DRUG

Metronidazole 500 mg

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

DRUG

Ampicillin 2 GM Injection

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

DRUG

Amoxicillin 250 MG

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

DRUG

Azithromycin

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

DRUG

Erythromycin

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)

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Marissa Berry, MD · Ohio State University

• Kartik K Venkatesh, MD, PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-18

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations