ADAPT: Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial
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 |
---|---|---|
|
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
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
- 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
- IL-6 in amniotic fluid [8 days]
Mean difference in IL-6 at delivery or 8 days (which ever is first)
- IL-8 in cord blood [3 months (delivery)]
Mean difference in IL-8 in cord blood
- Respiratory ureaplasma colonization in neonate [3 months]
Culture of nasopharyngeal swab within 48 hours of delivery in neonates
- Latency to delivery [3 months]
Number days from admission to delivey
- Intra-amniotic infection [3 months (delivery)]
Incidence of maternal intra-amniotic infection at delivery
- Trend in amniotic fluid cytokines [8 days]
TNF alpha, IL-1B, IL-6, IL-8 over 8 day period from admission
- ureaplasma colonization of membranes [3 months]
Culture swab taken of membranes after delivery
- Histologic chorioamnionitis [3 months (delivery)]
incidence of histologic chorioamnionitis in placental pathology
Eligibility Criteria
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
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Fluid positive for ferning and/or nitrazine
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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.- 20G.119