Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis (AddaMAP)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 2

Conditions

Pneumococcal Meningitis

Treatments

Drug: Daptomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03480191

CHAVANET-PHRC-2016

Details and patient eligibility

About

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.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.