Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis

PHASE3CompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Sepsis
Interventions
DRUG

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.

DRUG

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."

Trial Locations (1)

35128

Ursula TRAFOJER, Padua

All Listed Sponsors
collaborator

Chiesi Farmaceutici S.p.A.

INDUSTRY

lead

PENTA Foundation

NETWORK

NCT01551394 - Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis | Biotech Hunter | Biotech Hunter