Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

NCT01556334 | Withdrawn Phase 3 DMC

• 1 other identifier: PEACE Trial-1011004323
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.

Conditions

Preterm Premature Ruptured Membranes

Keywords

premature ruptured membranes; azithromycin; erythromycin; latency; antibiotics

Outcome Measures

Primary Outcomes (1)

• Time to delivery

  To compare the mean time to delivery, using azithromycin versus erythromycin to prolong latency in PPROM patients. The working hypothesis for this aim is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.

  2 years

Study Arms (2)

Azithromycin

EXPERIMENTAL

Azithromycin 1g po

Drug: Azithromycin

Erythromycin

ACTIVE COMPARATOR

Erythromycin IV followed by po for a total of 5 days.

Drug: Erythromycin

Interventions

Azithromycin DRUG

Azithromycin 1g po

Also known as: amp/azithro

Azithromycin

Erythromycin DRUG

Erythromycin IV then PO

Also known as: amp/erythro

Erythromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women at least 18 years old
• Gestational age of 24 0/7 to 32 0/7 weeks
• Singleton gestation
• Randomization within 36 hours of rupture of membranes.
• Cervical dilation less than or equal to 4 cm.

You may not qualify if:

• Known lethal fetal anomaly
• Vaginal bleeding not associated with labor
• Maternal or fetal indication for delivery
• Diagnosis of chorioamnionitis on admission
• Cervical cerclage in place
• Placenta previa or other known placental anomalies
• Use of antibiotic therapy within 5 days.
• Allergy or other contraindications to erythromycin/azithromycin or steroid use.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Azithromycin; Erythromycin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• David M Haas, MD, MS

  IU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2012
• First Posted: March 16, 2012
• Study Start: April 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 15, 2024

Record last verified: 2014-03

Locations

US (1)