MEROPENEM FOR 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 10053840Term: Bacterial sepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

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

Inclusion Criteria

- Inform consent form signed by 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 regimn 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 in the infant is not expected to survive for more than 3 months;
- Other situations where the treating pysician 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 micororganisms known to be resistant to study therapies

Study & Design

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