Adjunction of daptomycin for the treatment of pneumococcal meningitis AddaMAP study

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 128

Inclusion Criteria

-Persons aged over 18 years
-With Suspected pneumococcal meningitis :
oclinical 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

oclearly purulent CSF with/ or,
opresence 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

All patients full-filling inclusion criteria and who will receive at least one injection of daptomycin will represent the safety population. The efficacy population will be composed of patients with proven pneumococcal meningitis (positive culture or PCR of the CSF or positive blood culture).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

MAIN NON-INCLUSION CRITERIA
1)Contraindication to cephalosporin
2)Immediate and severe hypersensitivity to ß-lactam antimicrobial
3)Contraindication to dexamethasone
4)Contraindication to daptomycin
5)Previous exposition to daptomycin (within one year)
6)Pregnant or breastfeeding women

EXCLUSION CRITERIA
-Patients under ward of court
-Refusal at any time after acceptation of the study from the patient or her/his legal representative.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact of the adjunction of daptomycin (10 mg/kg/d for 8 days) to the recommended treatment (corticotherapy + third generation cephalosporin) on disability-free survival (DFS) 30 days after treatment initiation (D30) in adult patients with pneumococcal meningitis.;<br> Secondary Objective: EFFICACY: To evaluate the impact of the adjunction of daptomycin to the recommended treatment on mortality, disability, hearing loss measured, quality of life, length of hospital stay at D30 and D90, and the number of days without antibiotics at D30.<br><br> SAFETY: To assess the safety of the daptomycin add-on therapy<br> ;Primary end point(s): Disability-free survival (survival with a modified Rankin scale = 2) ;Timepoint(s) of evaluation of this end point: at D30

Secondary Outcome Measures

Name	Time	Method

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