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Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes

Sponsor
Eastern Virginia Medical School (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05328817
Collaborator
(none)
240
Enrollment
2
Arms
38
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
In order to maintain balanced groups, block randomization will be used. Pregnant women will be randomized in blocks of 6 with a total number of blocks to be 40. This will be conducted using STATA16 software, which will generate random permutations of sequential IDs of eligible study participants and their assignment to the treatment arms. This will be transferred to the REDCap in which a database will be created to facilitate random assignment during recruitment while maintaining concealment of randomization.In order to maintain balanced groups, block randomization will be used. Pregnant women will be randomized in blocks of 6 with a total number of blocks to be 40. This will be conducted using STATA16 software, which will generate random permutations of sequential IDs of eligible study participants and their assignment to the treatment arms. This will be transferred to the REDCap in which a database will be created to facilitate random assignment during recruitment while maintaining concealment of randomization.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes: A Randomized Controlled Trial
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Erythromycin

Receive 1) erythromycin 250 mg iv every 6 hours for 48 hours followed by 333 mg orally (pills) every 8 hours for 5 days

Drug: Antibiotics
In the absence of labor, broad-spectrum antibiotics (often called latency antibiotics) are recommended for women with PPROM less than 34 weeks to reduce chorioamnionitis, prolong latency, and decrease neonatal sepsis (12,13).
Other Names:
  • Latency antibiotics
  • Broad-spectrum antibiotics

    		•
    Experimental: Azithromycin

    Receive azithromycin 500 mg iv daily for 48 hours followed by 500 mg orally (pills) for 5 days.

    Drug: Antibiotics
    In the absence of labor, broad-spectrum antibiotics (often called latency antibiotics) are recommended for women with PPROM less than 34 weeks to reduce chorioamnionitis, prolong latency, and decrease neonatal sepsis (12,13).
    Other Names:
  • Latency antibiotics
  • Broad-spectrum antibiotics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Latency Period [At delivery]

      The time interval between the first antibiotic dose to time of delivery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Singleton pregnancy

    • PPROM from 22 weeks 0 days to 31 weeks 6 days at Sentara Norfolk General Hospital

    • Membrane rupture within 36 hours of randomization, cervical dilation 3 cm or less, and 4 or fewer contractions in the 60-minutes monitoring before randomization

    Exclusion Criteria:

    • Non-reassuring fetal heart tracing

    • Vaginal bleeding

    • Indications for delivery

    • Received any antibiotic therapy within 7 days other than initiation of Ampicillin treatment as part of latency antibiotics prior to transfer to Sentara Norfolk General Hospital

    • Allergy to penicillin, erythromycin, or azithromycin

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Eastern Virginia Medical School

    Investigators

    • Principal Investigator: Tetsuya Kawakita, MD, Eastern Virginia Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eastern Virginia Medical School
    ClinicalTrials.gov Identifier:
    NCT05328817
    Other Study ID Numbers:
    • 22-01-FB-0001
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Premature Birth
    Fetal Membranes, Premature Rupture
    Rupture
    Anti-Bacterial Agents
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Apr 14, 2022