Azithromycin Dose and PPROM Treatment: a Pilot Randomized... | NCT04294069

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

NCT04294069

Sponsor

Thomas Jefferson University

Status

Completed

Last Update Posted

Jul 27, 2023Actual

Enrollment

6Actual

Phase

Phase 4

Conditions

Preterm Premature Rupture of Membrane

Interventions

Azithromycin 500 mg
Azithromycin Oral Product

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2020Actual

Primary Completion Date

Dec 27, 2020Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Mar 2, 2020

First Posted Date

Mar 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 27, 2023Actual

Name	Class
Christiana Care Health Services	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azithromycin 500mg	Active Comparator	500mg azithromycin PO daily for seven days	Drug: Azithromycin 500 mg
Azithromycin 1000mg	Active Comparator	1000mg azithromycin PO once at admission	Drug: Azithromycin Oral Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin 500 mg	Drug	500mg azithromycin PO for seven days starting on admission	Azithromycin 500mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	8 days

Secondary Outcomes

Measure	Description	Time Frame
IL-6 in amniotic fluid	Mean difference in IL-6 at delivery or 8 days (which ever is first)	8 days
IL-8 in cord blood	Mean difference in IL-8 in cord blood

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupsa C Boelig, MD	Thomas Jefferson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University Hospital		Philadelphia	Pennsylvania	19107	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD available on request pending completion of data sharing agreement and approval of information requested

Types

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

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C563032	Preterm Premature Rupture of the Membranes

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017963	Azithromycin

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930

Browse Leaves

Not provided

Browse Branches

Not provided