Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

NCT03480191 | Completed Phase 2

• 1 other identifier: CHAVANET-PHRC-2016
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumococcal Meningitis

Outcome Measures

Primary Outcomes (1)

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

  At Day 30

Secondary Outcomes (12)

• Overall mortality

  At Day 30 and Day 90

• Disability level assessed with the mRS in surviving patients

  At Day 30 and Day 90

• Disability level assessed with the Glascow Coma Scale and the Glasgow Outcome Scale in the overall efficacy population

  At Day 30 and Day 90

• Disability level assessed with mini-mental score in surviving patients

  At Day 30 and Day 90

• Hearing loss assessed with the Hearing Handicap Inventory test

  At Day 30 and Day 90

Study Arms (1)

Patients

EXPERIMENTAL

Drug: Daptomycin

Interventions

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Affiliation to a social security system

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (2)

• Chavanet P, Fournel I, Bourredjem A, Piroth L, Blot M, Sixt T, Binquet C. Addition of daptomycin for the treatment of pneumococcal meningitis: protocol for the AddaMAP study. BMJ Open. 2023 Jul 25;13(7):e073032. doi: 10.1136/bmjopen-2023-073032.

  PMID: 37491088 DERIVED

• Wall EC, Chan JM, Gil E, Heyderman RS. Acute bacterial meningitis. Curr Opin Neurol. 2021 Jun 1;34(3):386-395. doi: 10.1097/WCO.0000000000000934.

  PMID: 33767093 DERIVED

MeSH Terms

Conditions

Meningitis, Pneumococcal

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: June 7, 2018
• Primary Completion: May 11, 2024
• Study Completion: August 21, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)