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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disability-free survival, assessed with the modified Rankin Scale (mRS) | At Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | At Day 30 and Day 90 | |
| Disability level assessed with the mRS in surviving patients | At Day 30 and Day 90 | |
| Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population |
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Inclusion Criteria:
Persons aged over 18 years
With Suspected pneumococcal meningitis :
Written consent or inclusion in an emergency
Affiliation to a social security system
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Dijon | 21000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37491088 | Derived | 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. | |
| 33767093 | Derived | Wall 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. |
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the study team is available to collaborate with other research teams on reasonable request to access study data
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| ID | Term |
|---|---|
| D008586 | Meningitis, Pneumococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
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| At Day 30 and Day 90 |
| Disability level assessed with mini-mental score in surviving patients | At Day 30 and Day 90 |
| Hearing loss assessed with the Hearing Handicap Inventory test | At Day 30 and Day 90 |
| Hearing loss assessed with audiometry | At Day 30 |
| Hearing loss assessed with the Hearing-it test | 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 | At Day 30 and Day 90 |
| Quality of life assessed with WHO QOL BREF | At Day 30 and Day 90 |
| Number of days without hospitalisation (including ICU) | At Day 30 and Day 90 |
| Number of days without antimicrobial therapy | At Day 30 |
| Frequency and type of side effects related to daptomycine | Within 30 days after daptomycin start |
| D007239 | Infections |
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D008055 |
| Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |