drugset / Trial / NCT05345457
Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
Phase 4
Terminated
1 enrolled
University Hospitals Cleveland Medical Center
MetroHealth Medical Center · collabThe Cleveland Clinic · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
Timeline
- Start
- 2023-01-13
- Primary completion
- 2024-02-26
- Completion
- 2024-02-26
Publications
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- Background Martinez MA, Vuppalanchi R, Fontana RJ, Stolz A, Kleiner DE, Hayashi PH, Gu J, Hoofnagle JH, Chalasani N. Clinical and histologic features of azithromycin-induced liver injury. Clin Gastroenterol Hepatol. 2015 Feb;13(2):369-376.e3. doi: 10.1016/j.cgh.2014.07.054. Epub 2014 Aug 9.
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- Background Andes D, Craig WA. In vivo activities of amoxicillin and amoxicillin-clavulanate against Streptococcus pneumoniae: application to breakpoint determinations. Antimicrob Agents Chemother. 1998 Sep;42(9):2375-9. doi: 10.1128/AAC.42.9.2375.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Subject | Azithromycin | Small molecule | 250 mg | Oral |