Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial (ADAPT)

Thomas Jefferson University

Status and phase: Completed; Phase 4

Conditions: Preterm Premature Rupture of Membrane

Treatments: Drug: Azithromycin Oral Product; Drug: Azithromycin 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04294069

20G.119

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Azithromycin 500mg

Active Comparator group

Description:

500mg azithromycin PO daily for seven days

Treatment:

Drug: Azithromycin 500 mg

Azithromycin 1000mg

Active Comparator group

Description:

1000mg azithromycin PO once at admission

Treatment:

Drug: Azithromycin Oral Product