Infectious diseases account for an estimated 36% of neonatal deaths globally. The purpose of this study was to determine safe, effective, simplified dosing regimens of gentamicin for treatment of neonatal sepsis in developing countries.
Neonates with suspected sepsis in the neonatal intensive care unit (NICU) at Christian Medical College and Hospital (CMC), Vellore, India (n = 49), and Dhaka Shishu Hospital (DSH), Bangladesh (n = 59), were administered gentamicin intravenously according to the following regimens: (1) 10 mg every 48 hours for neonates <2000 g; (2) 10 mg every 24 hours for neonates 2000–2249 g; and (3) 13.5 mg every 24 hours for neonates ≥2500 g. Serum gentamicin concentration (SGC) at steady state and pharmacokinetic indices were determined. Renal function was followed while under treatment and hearing was examined 6 weeks to 3 months after discharge.
All neonates, except 1 weighing 2000–2249 g at DSH, had a peak SGC >4 μg/mL. Overall, 5 (10%) and 17 (29%) infants had a peak SGC level ≥12 μg/mL from CMC and DSH, respectively, and 10 (20%) and 4 (7%) cases from CMC and DSH, respectively, had a trough SGC level ≥2 μg/mL. However, no infant <2000 g had a trough SGC level ≥2 μg/mL. We found no evidence of gentamicin nephrotoxicity or ototoxicity.
Safe, therapeutic gentamicin dosing regimens were identified for treatment of neonatal sepsis in developing country settings. Administration of these doses could be simplified through use of Uniject, a prefilled, single injection device designed to make injections safe and easy to deliver in developing country settings.
From the *Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Departments of †Neonatology and §Microbiology, Institute of Child Health, Dhaka Shishu Hospital, Dhaka, Bangladesh; Department of ‡Neonatology, Christian Medical College and Hospital, Vellore, India; ∥Department of Pharmacology, Duke University, Durham, NC; ¶Department of Pharmacy Practice, Wayne State University; #NIH/NICHD Pediatric Pharmacology Research Unit Network, Children's Hospital of Michigan, Wayne State University, Detroit, MI; and **PATH, Seattle, WA.
Accepted for publication March 9, 2007.
Address for correspondence: Gary L. Darmstadt, MD, MS, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. E-mail: firstname.lastname@example.org.