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Macrolide Antibiotic

Azithromycin for Premature Rupture of Membranes (PRACET Trial)

Q: Is it possible for me to participate in this research study?

To qualify for participation in this research study, individuals must have experienced premature rupture of membranes and be between 18 and 50 years old. This trial aims to enroll approximately 140 eligible candidates.

Q: Are there any available openings for patients to participate in this medical study?

According to the details on clinicaltrials.gov, this investigation is currently not seeking new participants. It was initially listed on 3/1/2024 and last revised on 2/20/2024. Despite this trial being inactive for recruitment presently, there are numerous other studies actively looking for suitable candidates at present numbering up to 89 trials.

Q: Are individuals older than 25 years eligible for participation in this research study?

Patients aged between 18 and 50 are sought for participation in this clinical study. There are separate trials available specifically for participants under 18 years old (20 trials) and those over the age of 65 (42 trials).

Phase 3

Recruiting

Led By Ellen M Murrin, DO

Research Sponsored by Inova Fairfax Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 and <50 years

Pregnancy at 22 weeks 0 days to 32 weeks 6 days of gestation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up number of days from pprom to delivery, assessed up to 105 days

Awards & highlights

PRACET Trial Summary

This trial aims to find the most effective antibiotic treatment for pregnant individuals whose water breaks early (PPROM). Antibiotics can help prolong the pregnancy to reduce risks to the baby, but it's unclear which

Who is the study for?

This trial is for pregnant individuals whose water has broken prematurely (PPROM) before reaching 34 weeks of gestation. They should not have any known allergies to the antibiotics being tested and must be in a condition where prolonging pregnancy is considered safe.Check my eligibility

What is being tested?

The study aims to determine which antibiotic, azithromycin or erythromycin, when combined with ampicillin and amoxicillin, is more effective at extending pregnancy after early water breakage. Participants will receive one of these antibiotics randomly along with standard care.See study design

What are the potential side effects?

Possible side effects from the antibiotics may include gastrointestinal issues like diarrhea or nausea, allergic reactions, liver problems, and changes in taste sensation. Side effects can vary based on individual tolerance.

PRACET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 49 years old.

Select...

I am between 22 and 32 weeks pregnant.

PRACET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ number of days from pprom to delivery, assessed up to 105 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~number of days from pprom to delivery, assessed up to 105 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and number of days from pprom to delivery, assessed up to 105 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Latency period

PRACET Trial Design

2Treatment groups

Active Control

Group I: AzithromycinActive Control1 Intervention

Azithromycin 1 gm PO once or 500 mg PO followed by 250 mg PO daily for a total of 5 days

Group II: ErythromycinActive Control1 Intervention

Erythromycin 250 mg IV every 6 hours for 48 hours, followed by 250 mg PO or 333 mg PO every 8 hours for 5 days

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Inova Fairfax HospitalLead Sponsor

10 Previous Clinical Trials

7,539 Total Patients Enrolled

Ellen M Murrin, DOPrincipal InvestigatorInova Health Systems

Antonio Saad, MD, MBAPrincipal InvestigatorInova Health Systems

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research study?

"To qualify for participation in this research study, individuals must have experienced premature rupture of membranes and be between 18 and 50 years old. This trial aims to enroll approximately 140 eligible candidates."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"According to the details on clinicaltrials.gov, this investigation is currently not seeking new participants. It was initially listed on 3/1/2024 and last revised on 2/20/2024. Despite this trial being inactive for recruitment presently, there are numerous other studies actively looking for suitable candidates at present numbering up to 89 trials."

Answered by AI

Are individuals older than 25 years eligible for participation in this research study?

"Patients aged between 18 and 50 are sought for participation in this clinical study. There are separate trials available specifically for participants under 18 years old (20 trials) and those over the age of 65 (42 trials)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Antonio Saad 2024. "Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06273891.

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