drugset / Trial / NCT06396078
Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)
RandomizedParallel-groupOpen-labelTreatment
Summary
To conduct an unblinded pragmatic randomized controlled trial (pRCT) "Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin/amoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \<34 weeks.
Timeline
- Start
- 2024-07-18
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 250 mg | — |
| Subject | Ampicillin | Unknown | 2 g | Intravenous |
| Subject | Azithromycin | Small molecule | 1 g | Oral |
| Subject | Ceftriaxone | Other / unclassified | 1 g | Intravenous |
| Subject | Clarithromycin | Small molecule | 500 mg | Oral |
| Subject | Erythromycin | Small molecule | 333 mg | Intravenous |
| Subject | Metronidazole | Small molecule | 500 mg | Oral |