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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294069
Recruitment Status : Not yet recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

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
Preterm Premature Rupture of Membrane 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294069


Contacts
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Contact: Rupsa Boelig, MD 215-955-9196 rupsa.boelig@jefferson.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Rupsa C Boelig, MD Thomas Jefferson University
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04294069    
Other Study ID Numbers: 20G.119
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD available on request pending completion of data sharing agreement and approval of information requested
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 1 year after publication of results
Access Criteria: IPD available on request pending completion of data sharing agreement and approval of information requested

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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:
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Premature Birth
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents