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NCT Number: NCT03480191

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

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.

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Key information

Conditions

Pneumococcal Meningitis Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Positive Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Pneumococcal Nervous System Diseases Neuroinflammatory Diseases Pneumococcal Infections Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

daptomycin

Drug

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 outcomes

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

    Time frame: At Day 30

Secondary outcomes

  1. Overall mortality

    Time frame: At Day 30 and Day 90

  2. Disability level assessed with the mRS in surviving patients

    Time frame: At Day 30 and Day 90

  3. 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

  4. Disability level assessed with mini-mental score in surviving patients

    Time frame: At Day 30 and Day 90

  5. Hearing loss assessed with the Hearing Handicap Inventory test

    Time frame: At Day 30 and Day 90

  6. Hearing loss assessed with audiometry

    Time frame: At Day 30

  7. Hearing loss assessed with the Hearing-it test

    Time frame: At Day 30

  8. 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

  9. Quality of life assessed with WHO QOL BREF

    Time frame: At Day 30 and Day 90

  10. Number of days without hospitalisation (including ICU)

    Time frame: At Day 30 and Day 90

  11. Number of days without antimicrobial therapy

    Time frame: At Day 30

  12. Frequency and type of side effects related to daptomycine

    Time frame: Within 30 days after daptomycin start

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: AddaMAP

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2018
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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