Status:
COMPLETED
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Collaborating Sponsors:
Radboud University Medical Center
Conditions:
Infection
Hospitalization
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
One small recent trial in elderly volunteers showed that BCG vaccination can protect against infectious complications, while several studies have demonstrated an increased capacity of innate immune re...
Detailed Description
In an era of antimicrobial resistance, where the already existing antimicrobials are not sufficient, the development of new strategies for the prevention and treatment of infections is of great intere...
Eligibility Criteria
Inclusion
- Male or female
- Age more than or equal to 65 years based on the precise date of birth
- Discharge from hospital after hospitalization for a medical cause. All medical causes make patients eligible for enrolment with the only exception of medical causes mentioned in the exclusion criteria
Exclusion
- Failure to obtain written informed consent
- Solid organ malignancy or lymphoma diagnosed the last five years
- Treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Severely immunocompromised patients. This exclusion category comprises: a) patients with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic patients with less than 500 neutrophils/mm3; c) patients with solid organ transplantation; d) patients with bone marrow transplantation; e) patients under chemotherapy; f) patients with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies
- Positive Interferon-gamma Release Assay (IGRA)
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03296423
Start Date
September 21 2017
End Date
November 30 2020
Last Update
January 11 2021
Active Locations (1)
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1
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Attica, Greece, 12462