Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

Pneumococcal Meningitis Clinical Trial

— AddaMAP  

Official title:

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480191
• Other study ID #: CHAVANET-PHRC-2016
• Status: Recruiting
• Phase: Phase 2
• Start date: June 7, 2018
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Pascal CHAVANET, MD
• Phone: 03 80 29 33 05
• Email: pascal.chavanet[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Meningitis
• Pneumococcal Meningitis

Intervention

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.

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability-free survival, assessed with the modified Rankin Scale (mRS)		At Day 30
Secondary	Overall mortality		At Day 30 and Day 90
Secondary	Disability level assessed with the mRS in surviving patients		At Day 30 and Day 90
Secondary	Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population		At Day 30 and Day 90
Secondary	Disability level assessed with mini-mental score in surviving patients		At Day 30 and Day 90
Secondary	Hearing loss assessed with the Hearing Handicap Inventory test		At Day 30 and Day 90
Secondary	Hearing loss assessed with audiometry		At Day 30
Secondary	Hearing loss assessed with the Hearing-it test		At Day 30
Secondary	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	At Day 30 and Day 90
Secondary	Quality of life assessed with WHO QOL BREF		At Day 30 and Day 90
Secondary	Number of days without hospitalisation (including ICU)		At Day 30 and Day 90
Secondary	Number of days without antimicrobial therapy		At Day 30
Secondary	Frequency and type of side effects related to daptomycine		Within 30 days after daptomycin start