Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis (AddaMAP)
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|ClinicalTrials.gov Identifier: NCT03480191|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : July 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Meningitis||Drug: Daptomycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study|
|Actual Study Start Date :||June 7, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||September 2021|
- Drug: Daptomycin
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.
- Disability-free survival, assessed with the modified Rankin Scale (mRS) [ Time Frame: At Day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480191
|Contact: Pascal CHAVANET, MD||03 80 29 33 firstname.lastname@example.org|
|CHU Dijon Bourgogne||Recruiting|
|Dijon, France, 21000|
|Contact: Pascal CHAVANET, MD 03 80 29 33 05 email@example.com|