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

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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

Tracking Information
First Submitted Date  ICMJE February 18, 2020
First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 3, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • IL-6 in amniotic fluid [ Time Frame: 8 days ]
    Mean difference in IL-6 at delivery or 8 days (which ever is first)
  • IL-8 in cord blood [ Time Frame: 3 months (delivery) ]
    Mean difference in IL-8 in cord blood
  • Respiratory ureaplasma colonization in neonate [ Time Frame: 3 months ]
    Culture of nasopharyngeal swab within 48 hours of delivery in neonates
  • Latency to delivery [ Time Frame: 3 months ]
    Number days from admission to delivey
  • Intra-amniotic infection [ Time Frame: 3 months (delivery) ]
    Incidence of maternal intra-amniotic infection at delivery
  • Trend in amniotic fluid cytokines [ Time Frame: 8 days ]
    TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission
  • ureaplasma colonization of membranes [ Time Frame: 3 months ]
    Culture swab taken of membranes after delivery
  • Histologic chorioamnionitis [ Time Frame: 3 months (delivery) ]
    incidence of histologic chorioamnionitis in placental pathology
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
Official Title  ICMJE Azithromycin Pharmacokinetics and Pharmacodynamics in Pregnancy and Preterm Birth Prevention: Optimizing Dosing to Improve Maternal and Neonatal Outcomes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Preterm Premature Rupture of Membrane
Intervention  ICMJE
  • Drug: Azithromycin 500 mg
    500mg azithromycin PO for seven days starting on admission
  • Drug: Azithromycin Oral Product
    1000mg azithromycin PO once at admission
Study Arms  ICMJE
  • Active Comparator: Azithromycin 500mg
    500mg azithromycin PO daily for seven days
    Intervention: Drug: Azithromycin 500 mg
  • Active Comparator: Azithromycin 1000mg
    1000mg azithromycin PO once at admission
    Intervention: Drug: Azithromycin Oral Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rupsa Boelig, MD 215-955-9196 rupsa.boelig@jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04294069
Other Study ID Numbers  ICMJE 20G.119
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rupsa C Boelig, MD Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP