Meropenem fot the treatment of serious bacterial infections in neonates and young infants

• Conditions: suspected or proven late onset neonatal sepsis; MedDRA version: 14.1Level: PTClassification code 10040049Term: Sepsis neonatalSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-001515-31-LT
• Lead Sponsor: PENTA Foundation Onlus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-14
• 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 antibiotic regimen for more than 24 hours
prior to the administration of the study drug, 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
for 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