(76) Multi-Country Trial of Intrapartum Oral Azithromycin: Cultures of Neonatal Infections

Objective: An intrapartum oral dose of azithromycin (AZI) reduced maternal but not neonatal/fetal death or sepsis. Herein, we compare the frequency of neonatal cultures, organisms and antimicrobial resistance from neonatal infections by AZI vs. placebo groups.

Study Design: Ancillary study of the NICHD A-PLUS trial in which women in labor, ≥28 weeks’ and planning vaginal birth were randomized to 2g AZI vs. placebo at 8 sites in 7 low- and middle-income countries (LMICs). Culture specimens from suspected newborn infections including sepsis (blood), meningitis (cerebrospinal fluid, CSF), umbilical stump, eye or skin infections (free pus) were evaluated using standard of care clinical microbiological procedures with the addition of AZI susceptibility testing.

Results: Of 29,278 women (29,354 fetuses) randomized, 14,628 had AZI vs. 14,726 placebo. The AZI group was not associated with frequency of neonatal cultures (any source), culture positivity or AZI resistance among those randomized nor with actual neonatal cultures (Table 1A). The most prevalent neonatal pathogens (Table 1B) were gram positive-cocci (GPCs - S. aureus and MRSA) followed by gram-negative rods (GNRs - E. coli, K. pneumonia and Acinetobacter species). The findings were similar when specimens were limited to blood and CSF only.

Conclusion: A single intrapartum oral dose of AZI was not associated with the frequency of cultures, culture-positivity or baseline AZI resistance in LMICs. The organisms identified were predominantly expected gram-positive cocci and gram-negative rods with overall AZI resistance of ranging from 60-90%.