MedDRA version: 20.0 Level: PT Classification code 10027253 Term: Meningitis pneumococcal System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: CUBICIN
Product Name: Daptomycine
Pharmaceutical Form: Powder for solution for injection/infusion
Sponsors
CHU Dijon Bourgogne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Persons aged over 18 years - With Suspected pneumococcal meningitis : o 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 o clearly purulent CSF with/ or, o 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. SAFETY: To assess the safety of the daptomycin add-on therapy ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): EFFICACY 1) Overall mortality at D30 and D90 2) Disability level assessed with i) the mRS at D30 and at D90 in surviving patients, ii) the Glasgow Coma Scale and the Glasgow Outcome Scale at D30 and D90 in the overall efficacy population and iii) mini-mental score at D30 and D90 in surviving patients. 3) Hearing loss assessed with the Hearing Handicap Inventory test at D30 and D90 and with routine audiometric tests and the Hein test at D30 4) Quality of life assessed with SF12 and WHO QOL BREF at D30 and at D90 5) Number of days without hospitalisation (including ICU) at D30 and D90) Number of days without antimicrobial therapy at D30 SAFETY Frequency and type of side effects related to daptomycin within 90 days after inclusion;Timepoint(s) of evaluation of this end point: EFFICACY: 1) at D30 and D90 2) at D30 and D90 3) at D30 and D90 for the Hearing Handicap Inventory / at D30 for routine audiometric tests and the Hein test 4) at D30 and D90 5) at D30 and D90 for number of days without hospitalisation / at D30 for number of days without antimicrobial therapy | — |
Countries
France
Contacts
Public ContactChef de projets recherche
CHU Dijon Bourgogne
Outcome results
None listed