Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study

CHAVANET-PHRC-2016

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.

2018-06-07

2024-06-01

2024-09-01

Recruiting

Early phase I

128

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 128, 'type': 'ESTIMATED'}}

2023-10-23