Adjunction of daptomycin for the treatment of pneumococcal meningitis AddaMAP study

CHU Dijon Bourgogne0 个研究点目标入组 128 人开始时间: 2017年7月21日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•-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

•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.

发起方

CHU Dijon Bourgogne