272
Participants
Start Date
September 30, 2012
Primary Completion Date
December 31, 2014
Study Completion Date
December 31, 2014
Meropenem
20 mg/kg every 8 hours (every 12 hours in the youngest age group: \< 32 weeks GA and \< 2 weeks postnatal age). The dose will be given as an infusion over 30 minutes. Treatment duration is 11 ± 3 days.
Ampicillin + gentamicin or cefotaxime + gentamicin
"Ampicillin:~Neonates below 7 days: 50mg/kg every 12 hours Neonates 7-21 days: 50mg/kg every 8 hours Neonates and Infants from day 22 on: 50mg/kg every 6 hours~Gentamicin:~Neonates less than 32 weeks of corrected age: 5mg/kg every 36 hours Neonates 32 weeks and over of corrected age: 5mg/kg every 24 hours (pre-dose ('trough') concentrations should be less than 2mg/l) Infants over 28 days of postnatal age: once daily dose: initially 5-7mg/kg, then adjust according to serum-gentamicin concentration (pre-dose ('trough') concentrations should be less than 1mg/l)~Cefotaxime:~Neonates below 7 days of PNA: 50mg/kg every 12 hours Neonates and infants from day 7 of PNA: 50mg/kg every 8 hours Treatment duration is 11 ± 3 days."
Ursula TRAFOJER, Padua
Chiesi Farmaceutici S.p.A.
INDUSTRY
PENTA Foundation
NETWORK