Azithromycin Dose and PPROM Treatment: a Pilot Randomized Controlled Trial (ADAPT)
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ClinicalTrials.gov Identifier: NCT04294069 |
Recruitment Status :
Recruiting
First Posted : March 3, 2020
Last Update Posted : February 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preterm Premature Rupture of Membrane | Drug: Azithromycin 500 mg Drug: Azithromycin Oral Product | Phase 4 |
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 |
Actual Study Start Date : | September 14, 2020 |
Estimated Primary Completion Date : | October 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Azithromycin 500mg
500mg azithromycin PO daily for seven days
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Drug: Azithromycin 500 mg
500mg azithromycin PO for seven days starting on admission |
Active Comparator: Azithromycin 1000mg
1000mg azithromycin PO once at admission
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Drug: Azithromycin Oral Product
1000mg azithromycin PO once at admission |
- 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
- 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

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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 |
Inclusion Criteria:
- Singleton gestation 24 0/7 -33 0/7 weeks'
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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:
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• Contraindication to azithromycin
- Active labor, abruption, chorioamnionitis at enrollment
- Other contraindication to expectant management of PPROM at enrollment

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
Contact: Rupsa Boelig, MD | 215-955-9196 | rupsa.boelig@jefferson.edu |
United States, Delaware | |
Christiana Care Health Services | Not yet recruiting |
Newark, Delaware, United States, 19718 | |
Contact: Matthew Hoffman, MD | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: Rupsa C Boelig, MD rupsa.boelig@jefferson.edu |
Principal Investigator: | Rupsa C Boelig, MD | Thomas Jefferson University |
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: | February 11, 2022 |
Last Verified: | January 2022 |
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 |
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 |
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 |