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Determination of Extended-Interval Gentamicin Dosing for Neonatal Patients in Developing Countries

Darmstadt, Gary L. MD, MS*; Hossain, M Monir MBBS, FCPS, MD†; Jana, Atanu Kumar MD, DCH‡; Saha, Samir K. PhD§; Choi, Yoonjoung DrPH*; Sridhar, S Dip NB, DCH‡; Thomas, Niranjan MD, DCH, Dip NB‡; Miller-Bell, Mary PharmD∥; Edwards, David PharmD¶#; Aranda, Jacob MD, PhD#; Willis, Jeffrey PhD*; Coffey, Patricia PhD, MPH**

Pediatric Infectious Disease Journal: June 2007 - Volume 26 - Issue 6 - pp 501-507
doi: 10.1097/INF.0b013e318059c25b
Original Studies

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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: gdarmsta@jhsph.edu.

© 2007 Lippincott Williams & Wilkins, Inc.