Meropenem for the treatment of serious bacterial infections in neonates and infants below 90 days of age inclusive

• Conditions: late onset sepsis in the neonate and infant up to 90 days of age; MedDRA version: 17.0Level: PTClassification code 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-001515-31-EE
• Lead Sponsor: FONDAZIONE PENTA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-09
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• Informed consent form signed by the parents/carers • Chronological age below 90 days inclusive • Chronological age greater or equal to 72 hours of life at beginning of LOS • Clinical or confirmed sepsis*
Are the trial subjects under 18? yes
Number of subjects for this age range: 550
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Administration of any systemic antibiotics for more than 24 hours prior to the randomisation, unless the change is driven by the lack of efficacy of the former regimen; • Severe congenital malformations if the infant is not expected to survive for more than 3 months; • Other situations where the treating physician considers a different antibiotic regimen necessary; • Known intolerance or contraindication to study medication; • Participation in any other clinical study of investigational drugs; • Renal failure (as defined by Akcan-Arikan et al., 2007) and requirement of haemofiltration or peritoneal dialysis; • Confirmed sepsis with microorganisms known to be resistant to study therapies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified