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This antibiotic prophylaxis regimen is a specific combination therapy protocol employed in the TAILORED-PROM Phase 3 clinical trial, led by The Central and Eastern European Gynecologic Oncology Group (CEEGOG). The regimen is indicated for patients presenting with preterm premature rupture of membranes (pPROM) to prevent maternal and neonatal infections, such as Group B Streptococcus (GBS) sepsis, and to prolong the latency period before delivery. It consists of intravenous benzylpenicillin (Penicillin G) for GBS prophylaxis and oral clarithromycin, a macrolide antibiotic. The trial investigates whether a tailored approach, adjusting this prophylaxis and corticosteroid administration based on amniotic fluid interleukin-6 (IL-6) levels, can improve pregnancy prolongation and neonatal outcomes compared to standard fixed-regimen management. In cases of suspected intra-amniotic infection or high IL-6 levels, the regimen may be escalated to broad-spectrum antibiotics such as ampicillin/sulbactam and gentamicin.
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