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

  • STATUS
    Recruiting
  • End date
    Sep 7, 2024
  • participants needed
    128
  • sponsor
    Centre Hospitalier Universitaire Dijon
Updated on 1 March 2022
antibiotics
meningitis

Summary

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.

Details
Condition Pneumococcal Meningitis
Treatment Daptomycin
Clinical Study IdentifierNCT03480191
SponsorCentre Hospitalier Universitaire Dijon
Last Modified on1 March 2022

Eligibility

Yes No Not Sure

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 -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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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