A Phase 2 interventional study of Daptomycin in Pneumococcal Meningitis, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Centre Hospitalier Universitaire Dijon · Phase 2, Interventional, and Treatment
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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.
Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
With Suspected pneumococcal meningitis :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Daptomycin
Daptomycin will be given by intravenous infusion and administered over a 30 minutes infusion, daily, for 8 days and at the dosis of 10mg/kg/day.
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Time frame: At Day 30
Overall mortality
Time frame: At Day 30 and Day 90
Disability level assessed with the mRS in surviving patients
Time frame: At Day 30 and Day 90
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Time frame: At Day 30 and Day 90
Disability level assessed with mini-mental score in surviving patients
Time frame: At Day 30 and Day 90
Hearing loss assessed with the Hearing Handicap Inventory test
Time frame: At Day 30 and Day 90
Hearing loss assessed with audiometry
Time frame: At Day 30
Hearing loss assessed with the Hearing-it test
Time frame: At Day 30
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame: At Day 30 and Day 90
Quality of life assessed with WHO QOL BREF
Time frame: At Day 30 and Day 90
Number of days without hospitalisation (including ICU)
Time frame: At Day 30 and Day 90
Number of days without antimicrobial therapy
Time frame: At Day 30
Frequency and type of side effects related to daptomycine
Time frame: Within 30 days after daptomycin start
Plan to share: Yes — the study team is available to collaborate with other research teams on reasonable request to access study data
Ran from Jun 2018 to primary completion in May 2024, 71 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Daptomycin
Meningitis, Pneumococcal
Centre Hospitalier Universitaire Dijon →