late onset sepsis in the neonate and infant up to 90 days of age MedDRA version: 17.0 Level: PT Classification code 10053840 Term: Bacterial sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
FONDAZIONE PENTA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2 days after completion of therapy;Main Objective: To compare the efficacy at TOC visit of meropenem to the standard of care in the treatment of clinical or confirmed LOS in infants = 90 days of postnatal age.;Secondary Objective: • To compare the safety profile of meropenem to SOC. • To compare the efficacy at TOC visit of meropenem to SOC in confirmed sepsis. • To compare the response to meropenem and SOC on day 3 of antibacterial therapy. • To compare the efficacy at TOC visit of meropenem to SOC ignoring the change of antibiotics for safety reasons. • To compare the efficacy at TOC visit of meropenem to SOC by SOC regimen. • To compare survival at Day 28 in the meropenem arm and SOC arm. • To evaluate new infections and relapses that occur between TOC and FU visits in participants with a favourable outcome at TOC visit. • To define the organisms causing LOS. • To study antibacterial susceptibility of LOS-causing organisms and to describe clinical and microbiological responses according to this. • To compare gut colonization by resistant organisms after treatment with meropenem or SOC.;Primary end point(s): The primary endpoint is the outcome at the TOC visit performed 2 days after completion of an 11 ± 3 days full course of antibiotic treatment. A favourable outcome or a success is met when an infant fulfils all the following criteria: • Is alive • Has resolution or significant improvement (as defined in appendix B) of all abnormalities that defined LOS at entry and has no new clinical or laboratory abnormalities requiring a new course of antibiotic therapy • Has microbiological eradication either confirmed (absence of original baseline pathogen from appropriately obtained follow up specimen: CSF or blood or other sterile body fluids) or presumed (no source specimen but patient is assessed as clinically cured), and no new pathogens identified In the case of CoNS, two positive blood cultures collected | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Within day 28 from enrolment.;Secondary end point(s): • The description of all adverse events experienced by infants receiving meropenem or comparator agents - Clinical and biological adverse events will be recorded until FU visit and graded according to the need for a specific medical intervention (see page 40) - Auditory function parameters by brain-stem auditory evoked potentials will be assessed in all participants dosed with the trial drugs between EOAT and FU visit inclusive - Neurological evaluation by cerebral ultrasound (and if persistently abnormal, by magnetic resonance imaging (MRI) or computed tomography (CT) will be undertaken at any time between EOAT and the FU visit • Clinical, biological and microbiological response at Day 3, EOT, EOAT and COT • Survival at Day 28 • Time to NICU discharge • The organisms causing LOS in infants = 90 days of age • The presence of antibiotic resistant bacteria at enrolment, EOT, and prior to NICU discharge (FU or before) following meropenem or SOC therapies • PK of meropenem (for details see § 8.3.7.1 on Pharmacokinetics) • Genetic parameters that can affect response to therapy | — |
Countries
Estonia, Greece, Lithuania, Spain
Contacts
Public ContactFondazione PENTA Onlus
Fondazione PENTA Onlus
Outcome results
None listed