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Trial record 8 of 23 for:    "Bacterial Meningitis" | "Anti-Bacterial Agents"

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

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ClinicalTrials.gov Identifier: NCT03480191
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment Phase
Pneumococcal Meningitis Drug: Daptomycin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis: AddaMAP Study
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis
Drug Information available for: Daptomycin


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Disability-free survival, assessed with the modified Rankin Scale (mRS) [ Time Frame: At Day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480191


Contacts
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Contact: Pascal CHAVANET, MD 03 80 29 33 05 pascal.chavanet@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Pascal CHAVANET, MD    03 80 29 33 05    pascal.chavanet@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03480191     History of Changes
Other Study ID Numbers: CHAVANET-PHRC-2016
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningitis, Bacterial
Anti-Bacterial Agents
Meningitis, Pneumococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Central Nervous System Infections
Daptomycin
Anti-Infective Agents