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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04294069
Collaborator
Christiana Care Health Services (Other)
20
2
2
24.5
10
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Azithromycin 500 mg
  • Drug: Azithromycin Oral Product
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
Actual Study Start Date :
Sep 14, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Azithromycin 500mg

500mg azithromycin PO daily for seven days

Drug: Azithromycin 500 mg
500mg azithromycin PO for seven days starting on admission

Active Comparator: Azithromycin 1000mg

1000mg azithromycin PO once at admission

Drug: Azithromycin Oral Product
1000mg azithromycin PO once at admission

Outcome Measures

Primary Outcome Measures

  1. Azithromycin trough in amniotic fluid [8 days]

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

Secondary Outcome Measures

  1. IL-6 in amniotic fluid [8 days]

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

  2. IL-8 in cord blood [3 months (delivery)]

    Mean difference in IL-8 in cord blood

  3. Respiratory ureaplasma colonization in neonate [3 months]

    Culture of nasopharyngeal swab within 48 hours of delivery in neonates

  4. Latency to delivery [3 months]

    Number days from admission to delivey

  5. Intra-amniotic infection [3 months (delivery)]

    Incidence of maternal intra-amniotic infection at delivery

  6. Trend in amniotic fluid cytokines [8 days]

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

  7. ureaplasma colonization of membranes [3 months]

    Culture swab taken of membranes after delivery

  8. Histologic chorioamnionitis [3 months (delivery)]

    incidence of histologic chorioamnionitis in placental pathology

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christiana Care Health Services Newark Delaware United States 19718
2 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University
  • Christiana Care Health Services

Investigators

  • Principal Investigator: Rupsa C Boelig, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04294069
Other Study ID Numbers:
  • 20G.119
First Posted:
Mar 3, 2020
Last Update Posted:
Feb 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022