Meropenem for the treatment of serious bacterial infections in neonatesand young infants

• Conditions: suspected or proven late onset neonatal sepsis; MedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-07
• Last Update Posted: 4 August 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