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

Primary Purpose

Preterm Premature Rupture of Membrane

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azithromycin 500 mg
Azithromycin Oral Product
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Premature Rupture of Membrane

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Azithromycin 500mg

Azithromycin 1000mg

Arm Description

500mg azithromycin PO daily for seven days

1000mg azithromycin PO once at admission

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2020
Last Updated
July 24, 2023
Sponsor
Thomas Jefferson University
Collaborators
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT04294069
Brief Title
Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Acronym
ADAPT
Official Title
Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
December 27, 2020 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
Christiana Care Health Services

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin 500mg
Arm Type
Active Comparator
Arm Description
500mg azithromycin PO daily for seven days
Arm Title
Azithromycin 1000mg
Arm Type
Active Comparator
Arm Description
1000mg azithromycin PO once at admission
Intervention Type
Drug
Intervention Name(s)
Azithromycin 500 mg
Intervention Description
500mg azithromycin PO for seven days starting on admission
Intervention Type
Drug
Intervention Name(s)
Azithromycin Oral Product
Intervention Description
1000mg azithromycin PO once at admission
Primary Outcome Measure Information:
Title
Azithromycin trough in amniotic fluid
Description
Primary outcome is the mean difference in azithromycin trough (Cmin) in amniotic fluid between the two dosing regimens using nonparametric test
Time Frame
8 days
Secondary Outcome Measure Information:
Title
IL-6 in amniotic fluid
Description
Mean difference in IL-6 at delivery or 8 days (which ever is first)
Time Frame
8 days
Title
IL-8 in cord blood
Description
Mean difference in IL-8 in cord blood
Time Frame
3 months (delivery)
Title
Respiratory ureaplasma colonization in neonate
Description
Culture of nasopharyngeal swab within 48 hours of delivery in neonates
Time Frame
3 months
Title
Latency to delivery
Description
Number days from admission to delivey
Time Frame
3 months
Title
Intra-amniotic infection
Description
Incidence of maternal intra-amniotic infection at delivery
Time Frame
3 months (delivery)
Title
Trend in amniotic fluid cytokines
Description
TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission
Time Frame
8 days
Title
ureaplasma colonization of membranes
Description
Culture swab taken of membranes after delivery
Time Frame
3 months
Title
Histologic chorioamnionitis
Description
incidence of histologic chorioamnionitis in placental pathology
Time Frame
3 months (delivery)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupsa C Boelig, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD available on request pending completion of data sharing agreement and approval of information requested
IPD Sharing Time Frame
1 year after publication of results
IPD Sharing Access Criteria
IPD available on request pending completion of data sharing agreement and approval of information requested

Learn more about this trial

Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial

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