Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 9:54 PM
Study NCT ID:
NCT01551394
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis
Sponsor:
PENTA Foundation
Organization:
Study Overview
Official Title:
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age (Inclusive) With Clinical or Confirmed Late-onset Sepsis : a European Multicenter Randomised Phase III Trial
Status:
COMPLETED
Status Verified Date:
2015-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoMero-1
Brief Summary:
This phase III multicentric international randomized trial is designed to compare the efficacy of Meropenem to the standard of care in infants below 90 days of age with clinical or confirmed late-onset sepsis (LOS).
The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well known and documented in this population.
The aim is to assess efficacy , pharmacokinetics and safety of Meropenem which are not well known and documented in this population.
Detailed Description:
The principal objective is to compare the efficacy at test of cure (TOC) visit of meropenem to the standard of care (SOC) in the treatment of clinical or confirmed LOS in infants ≤ 90 days of postnatal age.
The secondary objectives are:
* 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 antibiotic(s) for safety reasons
* To compare the efficacy at TOC visit of meropenem to SOC by SOC regimen
* To compare survival at follow up (FU) visit (28 day visit) in the meropenem arm and SOC arm
* To compare new infections and relapses that occur between TOC and FU visits in participants with a favourable outcome at TOC visit by treatment arm
* 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 antibiotic resistant organisms after treatment with meropenem or SOC
* To compare bacterial eradication by treatment arm
* To compare time to NICU discharge across the 2 arms
* To describe PK of meropenem in infants ≤ 90 days of postnatal age with LOS
* To evaluate genetic parameters that may affect response to therapy
The secondary objectives are:
* 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 antibiotic(s) for safety reasons
* To compare the efficacy at TOC visit of meropenem to SOC by SOC regimen
* To compare survival at follow up (FU) visit (28 day visit) in the meropenem arm and SOC arm
* To compare new infections and relapses that occur between TOC and FU visits in participants with a favourable outcome at TOC visit by treatment arm
* 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 antibiotic resistant organisms after treatment with meropenem or SOC
* To compare bacterial eradication by treatment arm
* To compare time to NICU discharge across the 2 arms
* To describe PK of meropenem in infants ≤ 90 days of postnatal age with LOS
* To evaluate genetic parameters that may affect response to therapy
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: