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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03480191




Registration number
NCT03480191
Ethics application status
Date submitted
21/03/2018
Date registered
29/03/2018

Titles & IDs
Public title
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis
Scientific title
Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
Secondary ID [1] 0 0
CHAVANET-PHRC-2016
Universal Trial Number (UTN)
Trial acronym
AddaMAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Meningitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Daptomycin

Experimental: Patients -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disability-free survival, assessed with the modified Rankin Scale (mRS)
Timepoint [1] 0 0
At Day 30
Secondary outcome [1] 0 0
Overall mortality
Timepoint [1] 0 0
At Day 30 and Day 90
Secondary outcome [2] 0 0
Disability level assessed with the mRS in surviving patients
Timepoint [2] 0 0
At Day 30 and Day 90
Secondary outcome [3] 0 0
Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population
Timepoint [3] 0 0
At Day 30 and Day 90
Secondary outcome [4] 0 0
Disability level assessed with mini-mental score in surviving patients
Timepoint [4] 0 0
At Day 30 and Day 90
Secondary outcome [5] 0 0
Hearing loss assessed with the Hearing Handicap Inventory test
Timepoint [5] 0 0
At Day 30 and Day 90
Secondary outcome [6] 0 0
Hearing loss assessed with audiometry
Timepoint [6] 0 0
At Day 30
Secondary outcome [7] 0 0
Hearing loss assessed with the Hearing-it test
Timepoint [7] 0 0
At Day 30
Secondary outcome [8] 0 0
Quality of life assessed with the 12-Item Short Form Health Survey (SF-12)
Timepoint [8] 0 0
At Day 30 and Day 90
Secondary outcome [9] 0 0
Quality of life assessed with WHO QOL BREF
Timepoint [9] 0 0
At Day 30 and Day 90
Secondary outcome [10] 0 0
Number of days without hospitalisation (including ICU)
Timepoint [10] 0 0
At Day 30 and Day 90
Secondary outcome [11] 0 0
Number of days without antimicrobial therapy
Timepoint [11] 0 0
At Day 30
Secondary outcome [12] 0 0
Frequency and type of side effects related to daptomycine
Timepoint [12] 0 0
Within 30 days after daptomycin start

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindication to cephalosporin
* Immediate and severe hypersensitivity to ß-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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/08/2024
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Dijon

Funding & Sponsors
Primary sponsor type
Other
Name
Centre Hospitalier Universitaire Dijon
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
the study team is available to collaborate with other research teams on reasonable request to access study data
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03480191