Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

Preterm Premature Rupture of Membrane Clinical Trial

— ADAPT  

Official title:

Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294069
• Other study ID #: 20G.119
• Status: Completed
• Phase: Phase 4
• Start date: September 14, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: July 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. During the course of eight days participants will have serial collection of amniotic fluid, maternal serum; and at delivery, of placenta, membrane, and cord blood. After delivery, neonatal respiratory samples will be collected as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 1, 2021
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Drug:
• Azithromycin 500 mg
500mg azithromycin PO for seven days starting on admission
• Azithromycin Oral Product
1000mg azithromycin PO once at admission

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	IL-6 in amniotic fluid	Mean difference in IL-6 at delivery or 8 days (which ever is first)	8 days
Secondary	IL-8 in cord blood	Mean difference in IL-8 in cord blood	3 months (delivery)
Secondary	Respiratory ureaplasma colonization in neonate	Culture of nasopharyngeal swab within 48 hours of delivery in neonates	3 months
Secondary	Latency to delivery	Number days from admission to delivey	3 months
Secondary	Intra-amniotic infection	Incidence of maternal intra-amniotic infection at delivery	3 months (delivery)
Secondary	Trend in amniotic fluid cytokines	TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission	8 days
Secondary	ureaplasma colonization of membranes	Culture swab taken of membranes after delivery	3 months
Secondary	Histologic chorioamnionitis	incidence of histologic chorioamnionitis in placental pathology	3 months (delivery)