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NCT Number: NCT04294069

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

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.

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Key information

Conditions

Preterm Premature Rupture of Membrane Preterm Premature Rupture of the Membranes

Age range

14 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin 500 mg

Drug

500mg azithromycin PO for seven days starting on admission

Azithromycin Oral Product

Drug

1000mg azithromycin PO once at admission

Primary outcomes

  1. Azithromycin trough in amniotic fluid

    Time frame: 8 days

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

Secondary outcomes

  1. IL-6 in amniotic fluid

    Time frame: 8 days

    Mean difference in IL-6 at delivery or 8 days (which ever is first)

  2. IL-8 in cord blood

    Time frame: 3 months (delivery)

    Mean difference in IL-8 in cord blood

  3. Respiratory ureaplasma colonization in neonate

    Time frame: 3 months

    Culture of nasopharyngeal swab within 48 hours of delivery in neonates

  4. Latency to delivery

    Time frame: 3 months

    Number days from admission to delivey

  5. Intra-amniotic infection

    Time frame: 3 months (delivery)

    Incidence of maternal intra-amniotic infection at delivery

  6. Trend in amniotic fluid cytokines

    Time frame: 8 days

    TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission

  7. ureaplasma colonization of membranes

    Time frame: 3 months

    Culture swab taken of membranes after delivery

  8. Histologic chorioamnionitis

    Time frame: 3 months (delivery)

    incidence of histologic chorioamnionitis in placental pathology

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Christiana Care Health Services

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 3, 2020
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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