MeningitisPhase 1/2NeoMero-2NCT01554124
Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis
A Phase 1/2 study testing Meropenem in people with Meningitis, run by PENTA Foundation at 1 site in United Kingdom.
Trial summary
This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Meningitis
- What is being tested?
- Meropenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent form signed by the parents/carers
- Chronological age below 90 days inclusive
- The presence of:
- clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle),
- OR CSF pleocytosis (≥ 20 cells/mm3)
- OR a positive Gram stain of CSF.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age (Inclusive) With Probable and Confirmed Meningitis: A European Multicenter Phase I-II Trial
This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.
Read the detailed description
The primary objective will be 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.
The secondary objectives are :
- 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
- To evaluate functional genetic parameters that may affect response to therapy
- Conditions
- Meningitis
- Being tested
- Meropenem
- Keywords
- Meningitis, Neonates, Meropenem
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeropenemDrug
Also called Meropenem trihydrate
40 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age).
Treatment duration = 21 ± 7 days
| Study group | Role | What they receive |
|---|---|---|
| Meropenem | Experimental | Infants will received Meropenem 40 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age).
Treatment duration = 21 ± 7 days Receives: Drug: Meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis.
Pharmacokinetic analyses (AUC) will be carried out on the infants who received at least one dose of meropenem after inclusion in NeoMero-2.
The final model will be used for dosing simulations to give final dose recommendations.
Measured: 3-4 days
Nature, frequency and numbers of all adverse events under meropenem.
Adverse events will also be summarised according to the need of a specific medical intervention or not. Analyses by time period will also be shown (from D0 to TOC visit and from TOC visit to follow-up).
Measured: Up to 48 days
Secondary outcomes (1)
Percentage of patients with a favourable outcome defined at Test of Cure visit (TOC).
Patients with a favourable outcome defined at Test of Cure visit (TOC) 2 days after EOAT is met as an infant fulfilling the following criteria: Alive with clinical and bacteriological resolution 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).
Measured: An expected average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Sponsor
- Investigators
- Paul HEATH, Principal investigator, Paediatric Infectious Diseases St Georges, University of LondonJean-Pierre ABOULKER, Study chair, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554124
- Sponsor's protocol ID
- 2011-001521-25
- Acronym
- NeoMero-2
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2012
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age (Inclusive) With Probable and Confirmed Meningitis: A European Multicenter Phase I-II Trial
- ClinicalTrials.gov ID
- NCT01554124
- Acronym / sponsor ID
- NeoMero-2 / 2011-001521-25
- Conditions
- Meningitis
- Keywords
- Meningitis, Neonates, Meropenem
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Feb 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or confirmed bacterial meningitis.
Detailed description
The primary objective will be 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.
The secondary objectives are :
- 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
- To evaluate functional genetic parameters that may affect response to therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meropenem | Experimental | Drug: MeropenemInfants will received Meropenem 40 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age). Treatment duration = 21 ± 7 days |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Informed consent form signed by the parents/carers
- Chronological age below 90 days inclusive
- The presence of:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeropenemAlso: Meropenem trihydrate40 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age). Treatment duration = 21 ± 7 days | Drug | Meropenem |
Primary outcome
Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis.
Time frame: 3-4 days
Pharmacokinetic analyses (AUC) will be carried out on the infants who received at least one dose of meropenem after inclusion in NeoMero-2. The final model will be used for dosing simulations to give final dose recommendations.
Nature, frequency and numbers of all adverse events under meropenem.
Time frame: Up to 48 days
Adverse events will also be summarised according to the need of a specific medical intervention or not. Analyses by time period will also be shown (from D0 to TOC visit and from TOC visit to follow-up).
1 secondary outcome
Percentage of patients with a favourable outcome defined at Test of Cure visit (TOC).
Time frame: An expected average of 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Site dedicated to the NeoMero studiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul HEATH principal investigator
Paediatric Infectious Diseases St Georges, University of London
Jean-Pierre ABOULKER study chair
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Meropenem in people with Meningitis, run by PENTA Foundation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Meropenem (plasma and CSF) in infants ≤ 90 days of age diagnosed with probable and confirmed bacterial meningitis. (time frame: 3-4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.