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

October 19, 2023 updated by: Centre Hospitalier Universitaire Dijon

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

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHAVANET-PHRC-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the study team is available to collaborate with other research teams on reasonable request to access study data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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