Pneumococcal MeningitisPhase 2AddaMAPNCT03480191
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis
A Phase 2 study testing Daptomycin in people with Pneumococcal Meningitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a serious infection which is currently treated with a combination of corticosteroids (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated with meningitis are relatively frequent and severe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Meningitis
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2018to 21 Aug 2024
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons aged over 18 years
- With Suspected pneumococcal meningitis :
- clinical presentation evocative of pneumococcal meningitis : acute onset of ,meningeal signs, history of cranial trauma or fistula, knowledge of alteration of humoral immunity,, asplenia, alcoholism with/or
- clearly purulent CSF with/ or,
- presence of diplococcus on the Gram stain of CSF or positive pneumococcal antigen in the CSF, or polymorphonuclear cells in CSF > 100
- Written consent or inclusion in an emergency
- Affiliation to a social security system
Who cannot join
- Contraindication to cephalosporin
- Immediate and severe hypersensitivity to β-lactam antimicrobial
- Contraindication to dexamethasone
- Contraindication to daptomycin
- Previous exposition to daptomycin (within one year)
- Women who are able to procreate without effective contraception and pregnant or breastfeeding women
- Patients under ward of court
- Refusal at any time after acceptation of the study from the patient or her/his legal representative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a serious infection which is currently treated with a combination of corticosteroids (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated with meningitis are relatively frequent and severe. Recent animal studies have shown that another antibiotic, daptomycin, can reduce the mortality and long-term effects of pneumococcal meningitis. Daptomycin is widely used worldwide in humans for other diseases, with few side effects.
This study aims to evaluate the effect of daptomycin on the proliferation of the bacterial infection, and therefore on inflammation. Daptomycin will be added to the currently recommended treatment with the same dosage used for other diseases.
Read more
Roughly 130 patients with suspected pneumococcal meningitis admitted to the emergency departments of hospitals throughout France will be asked to participate in this study.
The participation period will last approximately 3 months.
- Conditions
- Pneumococcal Meningitis
- Being tested
- Daptomycin
- Medical subject headings
- Meningitis, Pneumococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Daptomycin will be given by intravenous infusion and administered over a 30 minutes infusion, daily, for 8 days and at the dosis of 10mg/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Measured: At Day 30
Secondary outcomes (12)
Overall mortality
Measured: At Day 30 and Day 90
Disability level assessed with the mRS in surviving patients
Measured: At Day 30 and Day 90
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Measured: At Day 30 and Day 90
Disability level assessed with mini-mental score in surviving patients
Measured: At Day 30 and Day 90
Hearing loss assessed with the Hearing Handicap Inventory test
Measured: At Day 30 and Day 90
Hearing loss assessed with audiometry
Measured: At Day 30
Hearing loss assessed with the Hearing-it test
Measured: At Day 30
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Measured: At Day 30 and Day 90
Quality of life assessed with WHO QOL BREF
Measured: At Day 30 and Day 90
Number of days without hospitalisation (including ICU)
Measured: At Day 30 and Day 90
Number of days without antimicrobial therapy
Measured: At Day 30
Frequency and type of side effects related to daptomycine
Measured: Within 30 days after daptomycin start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start7 Jun 2018
- Primary completion11 May 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal MeningitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480191
- Sponsor's protocol ID
- CHAVANET-PHRC-2016
- Acronym
- AddaMAP
- Status last verified
- Sep 2024
- First submitted
- 21 Mar 2018
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study team is available to collaborate with other research teams on reasonable request to access study data
Publications
Chavanet P, Fournel I, Bourredjem A, Piroth L, Blot M, Sixt T, Binquet C. Addition of daptomycin for the treatment of pneumococcal meningitis: protocol for the AddaMAP study. BMJ Open. 2023 Jul 25;13(7):e073032. doi: 10.1136/bmjopen-2023-073032.
PubMed 37491088Wall EC, Chan JM, Gil E, Heyderman RS. Acute bacterial meningitis. Curr Opin Neurol. 2021 Jun 1;34(3):386-395. doi: 10.1097/WCO.0000000000000934.
PubMed 33767093
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
- ClinicalTrials.gov ID
- NCT03480191
- Acronym / sponsor ID
- AddaMAP / CHAVANET-PHRC-2016
- Conditions
- Pneumococcal Meningitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
Pneumococcal meningitis is an infection of the membrane that covers the brain. It is a serious infection which is currently treated with a combination of corticosteroids (dexamethasone) and 3rd generation cephalosporins. Nevertheless, complications associated with meningitis are relatively frequent and severe. Recent animal studies have shown that another antibiotic, daptomycin, can reduce the mortality and long-term effects of pneumococcal meningitis. Daptomycin is widely used worldwide in humans for other diseases, with few side effects.
This study aims to evaluate the effect of daptomycin on the proliferation of the bacterial infection, and therefore on inflammation. Daptomycin will be added to the currently recommended treatment with the same dosage used for other diseases.
Roughly 130 patients with suspected pneumococcal meningitis admitted to the emergency departments of hospitals throughout France will be asked to participate in this study.
The participation period will last approximately 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Drug: Daptomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Persons aged over 18 years
- With Suspected pneumococcal meningitis :
- Written consent or inclusion in an emergency
- Affiliation to a social security system
Key exclusion criteria (8 listed)
- Contraindication to cephalosporin
- Immediate and severe hypersensitivity to β-lactam antimicrobial
- Contraindication to dexamethasone
- Contraindication to daptomycin
- Previous exposition to daptomycin (within one year)
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 |
|---|---|---|
| DaptomycinDaptomycin will be given by intravenous infusion and administered over a 30 minutes infusion, daily, for 8 days and at the dosis of 10mg/kg/day. | Drug | Patients |
Primary outcome
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Time frame: At Day 30
12 secondary outcomes
Overall mortality
Time frame: At Day 30 and Day 90
Disability level assessed with the mRS in surviving patients
Time frame: At Day 30 and Day 90
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Time frame: At Day 30 and Day 90
Disability level assessed with mini-mental score in surviving patients
Time frame: At Day 30 and Day 90
Hearing loss assessed with the Hearing Handicap Inventory test
Time frame: At Day 30 and Day 90
Hearing loss assessed with audiometry
Time frame: At Day 30
Hearing loss assessed with the Hearing-it test
Time frame: At Day 30
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Time frame: At Day 30 and Day 90
Quality of life assessed with WHO QOL BREF
Time frame: At Day 30 and Day 90
Number of days without hospitalisation (including ICU)
Time frame: At Day 30 and Day 90
Number of days without antimicrobial therapy
Time frame: At Day 30
Frequency and type of side effects related to daptomycine
Time frame: Within 30 days after daptomycin start
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 1 Oct 2024.
- Derived from this study: PubMed 37491088Chavanet P, Fournel I, Bourredjem A, Piroth L, Blot M, Sixt T, Binquet C. Addition of daptomycin for the treatment of pneumococcal meningitis: protocol for the AddaMAP study. BMJ Open. 2023 Jul 25;13(7):e073032. doi: 10.1136/bmjopen-2023-073032.
- Derived from this study: PubMed 33767093Wall EC, Chan JM, Gil E, Heyderman RS. Acute bacterial meningitis. Curr Opin Neurol. 2021 Jun 1;34(3):386-395. doi: 10.1097/WCO.0000000000000934.
- Individual participant dataSharing planned: Yes. the study team is available to collaborate with other research teams on reasonable request to access study data
Related trials for Pneumococcal Meningitis
RecruitingObservational study
National Bacterial Meningitis Study in Children and Newborns
Meningitis, Children, Only
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
RecruitingObservational study
Lebanese Interhospital Pneumococcal Surveillance Program
Pneumonia, Meningitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin in people with Pneumococcal Meningitis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 7 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 1 Oct 2024. 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 France. 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 phase mean?
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?
Disability-free survival, assessed with the modified Rankin Scale (mRS) (time frame: At Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480191, which also lists 2 linked publications.
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 1 Oct 2024.