Clinical trial NCT04294069: Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Official title: Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Premature Rupture of Membrane
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Christiana Care Health Services
First posted: 2020-03-03
Enrollment: 6
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Azithromycin trough in amniotic fluid
timeFrame: 8 days
Secondary outcomes:
measure: IL-6 in amniotic fluid
timeFrame: 8 days
measure: IL-8 in cord blood
timeFrame: 3 months (delivery)
measure: Respiratory ureaplasma colonization in neonate
timeFrame: 3 months
measure: Latency to delivery
timeFrame: 3 months
measure: Intra-amniotic infection
timeFrame: 3 months (delivery)
measure: Trend in amniotic fluid cytokines
timeFrame: 8 days
measure: ureaplasma colonization of membranes
timeFrame: 3 months
measure: Histologic chorioamnionitis
timeFrame: 3 months (delivery)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Rupsa C Boelig, MD
role: PRINCIPAL_INVESTIGATOR
References: