Meropenem in meningitis in children up to 90 days of age

Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase II trial - Neomero2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001521-25-EE

Enrollment

Registered

2011-09-19

Start date

2011-12-15

Completion date

Unknown

Last updated

2015-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial meningitis in children up to 90 days of age MedDRA version: 17.0 Level: LLT Classification code 10004049 Term: Bacterial meningitis System Organ Class: 100000004862

Interventions

Product Name: MEROPENEM Product Code: NA Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: MEROPENEM CAS Number: 96036-03-2 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Informed consent form signed by the parents/carers • Chronological age below 90 days inclusive • The presence of: clinical signs consistent with bacterial meningitis (clinical signs of meningitis are: fever or hypothermia or temperature instability PLUS 1 or more neurological findings e.g. coma, seizures, neck stiffness, apnoea, bulging fontanelle) OR CSF pleocytosis (= 20 cells / mm3 OR a positive Gram stain of CSF). Are the trial subjects under 18? yes Number of subjects for this age range: 60 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: • Presence of a CSF device • Proven viral or fungal meningitis • Severe congenital malformations if the infant is not to expect to survive for more than 3 months • Other situations where the treating physician considers a different empiric antibiotic regimen necessary • Known intolerance or contraindication to the study medication • Participation in any other clinical study of an investigational medicinal product • Renal failure and requirement of haemofiltration or peritoneal dialysis • Meningitis with an organism known to be resistant to meropenem

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants = 90 days of postnatal age with probable or confirmed bacterial meningitis and to characterize the safety profile of meropenem in the treatment of infants = 90 days of postnatal age with probable or confirmed bacterial meningitis.;Primary end point(s): • The PK of meropenem (plasma and CSF) in infants = 90 days of age diagnosed with probable and confirmed BM • Adverse events experienced by infants receiving meropenem. Clinical and biological adverse events will be recorded until FU visit.;Timepoint(s) of evaluation of this end point: Within day 45 of enrolment;Secondary Objective: • To describe the efficacy of meropenem on day 3, at end of allocated treatment (EOAT), at test of cure (TOC) and at follow up (FU). • To evaluate survival at FU • To evaluate further episodes of meningitis (relapse or new infection) occurring between TOC and FU visits • To define the organisms causing neonatal meningitis • To describe the antibacterial susceptibility of meningitis-causing organisms and to describe the clinical and microbiological response according to this • To evaluate mucosal colonization by resistant organisms before and after treatment with meropenem • To evaluate bacterial eradication	—

Measure

Time frame

Main Objective: To study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants = 90 days of postnatal age with probable or confirmed bacterial meningitis and to characterize the safety profile of meropenem in the treatment of infants = 90 days of postnatal age with probable or confirmed bacterial meningitis.;Primary end point(s): • The PK of meropenem (plasma and CSF) in infants = 90 days of age diagnosed with probable and confirmed BM • Adverse events experienced by infants receiving meropenem. Clinical and biological adverse events will be recorded until FU visit.;Timepoint(s) of evaluation of this end point: Within day 45 of enrolment;Secondary Objective: • To describe the efficacy of meropenem on day 3, at end of allocated treatment (EOAT), at test of cure (TOC) and at follow up (FU). • To evaluate survival at FU • To evaluate further episodes of meningitis (relapse or new infection) occurring between TOC and FU visits • To define the organisms causing neonatal meningitis • To describe the antibacterial susceptibility of meningitis-causing organisms and to describe the clinical and microbiological response according to this • To evaluate mucosal colonization by resistant organisms before and after treatment with meropenem • To evaluate bacterial eradication

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Within day 45 of enrolment;Secondary end point(s): • A favourable outcome defined at Test of Cure visit (TOC), 2 days after EOAT as an infant fulfilling the following criteria: Alive with clinical and bacteriological resolution (see appendix B) of the abnormalities that defined BM at entry and no occurrence of any new clinical or laboratory abnormalities requiring a new course of antibiotic therapy and no modification of the initial meropenem therapy (for more than 24 hours). • Clinical, biological and microbiological response at day 3, at EOAT, at TOC and at FU; • Survival at FU visit; • Auditory function as assessed by brain-stem auditory evoked potentials between COT and FU visits; • Neurological evaluation as assessed by cerebral ultrasound (and if persistently abnormal, by MRI or CT) at any time up until the FU visit; • The organisms causing neonatal meningitis; • The antibiotic susceptibility of bacteria causing BM; • Mucosal colonisation with antibiotic resistant bacteria or fungi at enrolment, EOAT and FU / discharge (whichever is earlier)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Within day 45 of enrolment;Secondary end point(s): • A favourable outcome defined at Test of Cure visit (TOC), 2 days after EOAT as an infant fulfilling the following criteria: Alive with clinical and bacteriological resolution (see appendix B) of the abnormalities that defined BM at entry and no occurrence of any new clinical or laboratory abnormalities requiring a new course of antibiotic therapy and no modification of the initial meropenem therapy (for more than 24 hours). • Clinical, biological and microbiological response at day 3, at EOAT, at TOC and at FU; • Survival at FU visit; • Auditory function as assessed by brain-stem auditory evoked potentials between COT and FU visits; • Neurological evaluation as assessed by cerebral ultrasound (and if persistently abnormal, by MRI or CT) at any time up until the FU visit; • The organisms causing neonatal meningitis; • The antibiotic susceptibility of bacteria causing BM; • Mucosal colonisation with antibiotic resistant bacteria or fungi at enrolment, EOAT and FU / discharge (whichever is earlier)

—

Countries

Estonia, Greece, Lithuania, Netherlands, Spain, United Kingdom

Contacts

Public ContactFondazione PENTA Onlus

Fondazione PENTA Onlus

management@neomero.org+390498213585

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026