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

Primary Purpose

Pneumococcal Meningitis

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumococcal Meningitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

Disability-free survival, assessed with the modified Rankin Scale (mRS)

Secondary Outcome Measures

Overall mortality
Disability level assessed with the mRS in surviving patients
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Disability level assessed with mini-mental score in surviving patients
Hearing loss assessed with the Hearing Handicap Inventory test
Hearing loss assessed with audiometry
Hearing loss assessed with the Hearing-it test
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
Quality of life assessed with WHO QOL BREF
Number of days without hospitalisation (including ICU)
Number of days without antimicrobial therapy
Frequency and type of side effects related to daptomycine

Full Information

First Posted
March 21, 2018
Last Updated
October 19, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT03480191
Brief Title
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis
Acronym
AddaMAP
Official Title
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Meningitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Time Frame
At Day 30
Secondary Outcome Measure Information:
Title
Overall mortality
Time Frame
At Day 30 and Day 90
Title
Disability level assessed with the mRS in surviving patients
Time Frame
At Day 30 and Day 90
Title
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
Title
Disability level assessed with mini-mental score in surviving patients
Time Frame
At Day 30 and Day 90
Title
Hearing loss assessed with the Hearing Handicap Inventory test
Time Frame
At Day 30 and Day 90
Title
Hearing loss assessed with audiometry
Time Frame
At Day 30
Title
Hearing loss assessed with the Hearing-it test
Time Frame
At Day 30
Title
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Description
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time Frame
At Day 30 and Day 90
Title
Quality of life assessed with WHO QOL BREF
Time Frame
At Day 30 and Day 90
Title
Number of days without hospitalisation (including ICU)
Time Frame
At Day 30 and Day 90
Title
Number of days without antimicrobial therapy
Time Frame
At Day 30
Title
Frequency and type of side effects related to daptomycine
Time Frame
Within 30 days after daptomycin start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal CHAVANET, MD
Phone
03 80 29 33 05
Email
pascal.chavanet@chu-dijon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu BLOT
Phone
0380293305
Email
mathieu.blot@chu-dijon.fr
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal CHAVANET, MD
Phone
03 80 29 33 05
Email
pascal.chavanet@chu-dijon.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
the study team is available to collaborate with other research teams on reasonable request to access study data
Citations:
PubMed Identifier
33767093
Citation
Wall EC, Chan JM, Gil E, Heyderman RS. Acute bacterial meningitis. Curr Opin Neurol. 2021 Jun 1;34(3):386-395. doi: 10.1097/WCO.0000000000000934.
Results Reference
derived

Learn more about this trial

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

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