NCT02868593

Brief Summary

The primary purpose of this study is to assess the contribution of a non-invasive sampling (pharyngeal swab) in the diagnosis of community based meningitis or meningo-encephalitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

3 years

First QC Date

August 11, 2016

Last Update Submit

August 11, 2016

Conditions

Community-based MeningitisMeningo-encephalitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with established etiological diagnosis of community based meningitis or meningo-encephalitis

    1 day

Study Arms (1)

Patient with clinical meningitis or meningo-encephalitis

EXPERIMENTAL
Other: Pharyngeal swab

Interventions

Pharyngeal swabOTHER
Patient with clinical meningitis or meningo-encephalitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is aged more than 18 years old.
  • Patient with clinical meningitis or meningo-encephalitis with community transmission.
  • Patient with a prescription of microbiological diagnosis of meningitis or meningo-encephalitis.
  • Patient who do not declined to have his medical records reviewed for research
  • Patient with health insurance

You may not qualify if:

  • Minor Patient (age \<18 years)
  • Pregnant woman, parturient or breastfeeding
  • Adult Patient under guardianship
  • Patient deprived of liberty under court order
  • Patient vital in emergency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

RECRUITING

Study Officials

  • Catherine GEINDRE

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Michel DRANCOURT

CONTACT

04 91 38 55 19michel.drancourt@ap-hm.fr

Alexandra GIULIANI

CONTACT

04 91 38 28 70alexandra.giuliani@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

FR(1)