Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes

Preterm Premature Rupture of Membrane Clinical Trial

Official title: Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

Aim 1. To examine the latency period according to antibiotic regimens (erythromycin iv for two days followed by orally for 5 days vs. azithromycin iv for 2 days followed by 5 days orally).

Aim 2. To examine the latency period according to races stratified by antibiotic regimens.

Aim 3: To examine if there is a difference in neonatal morbidity and mortality stratified by antibiotic regimen.

Clinical Trial Description

Significant differences exist in the pharmacokinetics and pharmacodynamics pathways of macrolide antibiotics between different races and ethnicities. Erythromycin compared to azithromycin interacts with more proteins and is likely affected by genetic variation. Therefore, the investigators hypothesize that the optimal latency antibiotic regimens for PPROM could potentially differ between races.

Due to the paucity of data regarding the use of an azithromycin regimen for latency antibiotics, the Eastern Virginia Medical School MFM team uses an erythromycin regimen even though azithromycin requires less frequent dosing, has lower rates of side effects, and is more cost effective. The Center for Maternal and Child Health Equity at Eastern Virginia Medical School was developed to address health disparities for mothers and their children, and the investigator team is committed to working with the center to address this research gap regarding latency antibiotic use in PPROM.

The aim is to determine the optimal antibiotic regimen for women with PPROM. The hypothesis to be tested are 1) The antibiotic regimen with azithromycin (iv for 2 days followed by 5 days orally) is associated with a longer latency period compared to the antibiotic regimen with erythromycin, and 2) The antibiotic regimen with azithromycin reduces disparity in latency period compared to the antibiotic regimen with erythromycin. ;

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

• NCT number: NCT05328817
• Study type: Interventional
• Source: Eastern Virginia Medical School
• Contact: Tetsuya Kawakita, MD
• Phone: 757-446-7900
• Email: kawakit@evms.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2022
• Completion date: July 1, 2025