- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480191
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis (AddaMAP)
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Pascal CHAVANET, MD
- Phone Number: 03 80 29 33 05
- Email: pascal.chavanet@chu-dijon.fr
Study Contact Backup
- Name: Mathieu BLOT
- Phone Number: 0380293305
- Email: mathieu.blot@chu-dijon.fr
Study Locations
-
-
-
Dijon, France, 21000
- Recruiting
- CHU dijon Bourgogne
-
Contact:
- Pascal CHAVANET, MD
- Phone Number: 03 80 29 33 05
- Email: pascal.chavanet@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Time Frame: At Day 30
|
At Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall mortality
Time Frame: At Day 30 and Day 90
|
At Day 30 and Day 90
|
|
Disability level assessed with the mRS in surviving patients
Time Frame: At Day 30 and Day 90
|
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
|
At Day 30 and Day 90
|
|
Disability level assessed with mini-mental score in surviving patients
Time Frame: At Day 30 and Day 90
|
At Day 30 and Day 90
|
|
Hearing loss assessed with the Hearing Handicap Inventory test
Time Frame: At Day 30 and Day 90
|
At Day 30 and Day 90
|
|
Hearing loss assessed with audiometry
Time Frame: At Day 30
|
At Day 30
|
|
Hearing loss assessed with the Hearing-it test
Time Frame: At Day 30
|
At Day 30
|
|
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Time Frame: At Day 30 and Day 90
|
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
|
At Day 30 and Day 90
|
Quality of life assessed with WHO QOL BREF
Time Frame: At Day 30 and Day 90
|
At Day 30 and Day 90
|
|
Number of days without hospitalisation (including ICU)
Time Frame: At Day 30 and Day 90
|
At Day 30 and Day 90
|
|
Number of days without antimicrobial therapy
Time Frame: At Day 30
|
At Day 30
|
|
Frequency and type of side effects related to daptomycine
Time Frame: Within 30 days after daptomycin start
|
Within 30 days after daptomycin start
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Infections
- Central Nervous System Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Meningitis, Bacterial
- Central Nervous System Bacterial Infections
- Pneumococcal Infections
- Neuroinflammatory Diseases
- Meningitis
- Meningitis, Pneumococcal
- Anti-Infective Agents
- Anti-Bacterial Agents
- Daptomycin
Other Study ID Numbers
- CHAVANET-PHRC-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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