Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

NCT04294069 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 20G.119
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized controlled trial to assess the pharmacokinetics and pharmacodynamics of azithromycin in pregnant singletons admitted with preterm premature rupture of membranes (PPROM) at 24 0/7- 33 0/7. Participants will be randomized 1:1 to either 1000mg azithromycin orally once or 500mg azithromycin orally daily for seven days in addition to standard care.

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• Azithromycin trough in amniotic fluid

  Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test

  8 days

Secondary Outcomes (8)

• IL-6 in amniotic fluid

  8 days

• IL-8 in cord blood

  3 months (delivery)

• Respiratory ureaplasma colonization in neonate

  3 months

• Latency to delivery

  3 months

• Intra-amniotic infection

  3 months (delivery)

Study Arms (2)

Azithromycin 500mg

ACTIVE COMPARATOR

500mg azithromycin PO daily for seven days

Drug: Azithromycin 500 mg

Azithromycin 1000mg

ACTIVE COMPARATOR

1000mg azithromycin PO once at admission

Drug: Azithromycin Oral Product

Interventions

Azithromycin 500 mg DRUG

500mg azithromycin PO for seven days starting on admission

Azithromycin 500mg

Azithromycin Oral Product DRUG

1000mg azithromycin PO once at admission

Azithromycin 1000mg

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation 24 0/7 -33 0/7 weeks'
• Diagnosed with preterm premature rupture of membranes:
• History consistent with ruptured membranes (ie leaking, gush of fluid)
• Sterile speculum exam with pooling
• Fluid positive for ferning and/or nitrazine
• With or without confirmatory test such as Amnisure

You may not qualify if:

• Contraindication to azithromycin
• Active labor, abruption, chorioamnionitis at enrollment
• Other contraindication to expectant management of PPROM at enrollment

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Christiana Care Health Services: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Rupsa C Boelig, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 3, 2020
• Study Start: September 14, 2020
• Primary Completion: December 27, 2020
• Study Completion: April 1, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year after publication of results
• Access Criteria: IPD available on request pending completion of data sharing agreement and approval of information requested

Locations

US (1)