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 > or =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 microg/mL. Overall, 5 (10%) and 17 (29%) infants had a peak SGC level > or =12 microg/mL from CMC and DSH, respectively, and 10 (20%) and 4 (7%) cases from CMC and DSH, respectively, had a trough SGC level > or =2 microg/mL. However, no infant <2000 g had a trough SGC level > or =2 microg/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.
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 > or =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 microg/mL. Overall, 5 (10%) and 17 (29%) infants had a peak SGC level > or =12 microg/mL from CMC and DSH, respectively, and 10 (20%) and 4 (7%) cases from CMC and DSH, respectively, had a trough SGC level > or =2 microg/mL. However, no infant <2000 g had a trough SGC level > or =2 microg/mL. We found no evidence of gentamicinnephrotoxicity 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.
Authors: Abdullah H Baqui; Shams E Arifeen; Emma K Williams; Saifuddin Ahmed; Ishtiaq Mannan; Syed M Rahman; Nazma Begum; Habibur R Seraji; Peter J Winch; Mathuram Santosham; Robert E Black; Gary L Darmstadt Journal: Pediatr Infect Dis J Date: 2009-04 Impact factor: 2.129
Authors: Jessica K Roberts; Chris Stockmann; Jonathan E Constance; Justin Stiers; Michael G Spigarelli; Robert M Ward; Catherine M T Sherwin Journal: Clin Pharmacokinet Date: 2014-07 Impact factor: 6.447
Authors: Abdullah H Baqui; Saifuddin Ahmed; Shams El Arifeen; Gary L Darmstadt; Amanda M Rosecrans; Ishtiaq Mannan; Syed M Rahman; Nazma Begum; Arif B A Mahmud; Habibur R Seraji; Emma K Williams; Peter J Winch; Mathuram Santosham; Robert E Black Journal: BMJ Date: 2009-08-14
Authors: M Monir Hossain; Nazma A Chowdhury; Mahfuza Shirin; Samir K Saha; Mary Miller-Bell; David Edwards; Jacob Aranda; Patricia Coffey; Gary L Darmstadt Journal: J Health Popul Nutr Date: 2009-10 Impact factor: 2.000