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Penicillin Antibiotic
Azithromycin vs. Erythromycin for Premature Rupture of Membranes (TREAT Trial)
Phase 3
Recruiting
Led By Nkechinyere Emezienna, MD
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age ≥ 18 years and <50 years
Pregnant women between the gestational age 23 6/7 and 32 6/7 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
TREAT Trial Summary
This trial is testing whether azithromycin is as effective as erythromycin in treating preterm premature rupture of membranes (PPROM), a pregnancy complication that can lead to preterm births.
Who is the study for?
This trial is for pregnant women aged 18-50, between 23+6/7 and 32+6/7 weeks of gestation with a single baby and PPROM. They must have less than 5cm cervical dilation, plan to deliver at JSH, and not have heart failure, placental anomalies, fetal demise, cerclage in place or allergies to the antibiotics used.Check my eligibility
What is being tested?
The study compares two antibiotic regimens for treating PPROM: azithromycin versus erythromycin combined with ampicillin. The goal is to see which treatment is more effective at prolonging pregnancy without causing significant side effects.See study design
What are the potential side effects?
Erythromycin may cause gastrointestinal upset leading some patients to struggle with the full course. Azithromycin tends to be easier on the stomach and has fewer issues related to digestive discomfort.
TREAT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 18 to 49.
Select...
I am pregnant and between 24 to 33 weeks along.
TREAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of women still pregnant by day 7
Secondary outcome measures
Latency defined as interval from PPROM to delivery.
TREAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AzithromycinExperimental Treatment3 Interventions
Ampicillin 2 gm IV every 6 hours followed by amoxicillin 500 mg PO every 8 hours with Azithromycin 1 gm PO once at randomization.
Group II: ErythromycinActive Control3 Interventions
Ampicillin 2 gm IV every 6 hours followed by amoxicillin 250 mg PO every 8 hours for 5 days with erythromycin 250 mg IV every 6 hours for 48 hours followed by 500 mg PO every 8 hours for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ampicillin
2015
Completed Phase 1
~830
Amoxicillin
2017
Completed Phase 4
~7780
Azithromycin
2018
Completed Phase 4
~274950
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
243 Previous Clinical Trials
56,347 Total Patients Enrolled
Nkechinyere Emezienna, MDPrincipal InvestigatorUniversity of Texas
Antonio F Saad, MDPrincipal InvestigatorAssistant Professor Maternal Fetal Medicine
5 Previous Clinical Trials
975 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am immunosuppressed, either due to medication, having HIV with CD4<200, or another reason.You have a baby with a birth defect.I am a woman aged 18 to 49.I have severe liver disease or my liver tests are three times higher than normal.I do not have an active bacterial infection like chorioamnionitis.You have a condition that makes it unsafe to wait and see (expectant management) during pregnancy.I have a cervical stitch in place.I have heart failure with reduced ejection fraction.You have a condition called placenta previa or other problems with your placenta.My kidney function is impaired, with creatinine over 2.0 mg/dl or I am on dialysis.I am pregnant and between 24 to 33 weeks along.
Research Study Groups:
This trial has the following groups:- Group 1: Azithromycin
- Group 2: Erythromycin
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what infections is Azithromycin commonly prescribed?
"Azithromycin is not only an effective way to treat bacterial conjunctivitis, but also other infections such as lower respiratory tract infection (lrti), genus chlamydia, and adult patients."
Answered by AI
What is the precedent for using Azithromycin in medical research?
"Azithromycin was first studied in 2011 at the Department of Pediatrics in Daping Hospital. 572 clinical trials have completed, with 116 more currently underway. Many of these ongoing studies are based in Galveston, Texas."
Answered by AI
Azithromycin: Is it possible for this drug to cause harm?
"Azithromycin is considered safe based on the clinical data available, and it received a score of 3."
Answered by AI
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