Status:
NOT_YET_RECRUITING
Efficacy of the Vacucis Candida® Autovaccine
Lead Sponsor:
University of Santiago de Compostela
Conditions:
Oral Candidiasis
Oral Candidiasis Recurrent
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It const...
Detailed Description
The design of a randomized, randomized (test and placebo) triple-blind (patient, investigator and evaluator) clinical trial is proposed. The clinical trial will be carried out in accordance with the c...
Eligibility Criteria
Inclusion
- Patients with a history of RT in the head and neck region that directly or indirectly involves any of the jaws.
- Adult patients
- Hemodynamically stable patients without contraindications to receive an autovaccine (see exclusion)
- Patients with a stable oncological situation without active tumor
- Patients who present candidiasis demonstrated by clinical examination (signs and symptoms of candidiasis) and microbiological (culture).
Exclusion
- Minor patients
- Pregnant patients
- Patients with an unstable medical situation, both from a hemodynamic and oncological point of view (advanced tumors with metastases, recurrences or inoperable tumors)
- Patients undergoing treatment with CT that involves an affectation of the immune system
- Patient under treatment with antifungals for mycoses of any origin
- Allergy to the active substance or to any of the other components of Vacucis.
- Serious disorders of the immune system.
- Diseases that severely affect immunity.
- Presence of fever.
- People with allergies to yeasts
- People with allergy to chloramphenicol
- Patients treated with MAOIs (monoamine oxidase inhibitors)
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05289375
Start Date
April 30 2025
End Date
December 31 2027
Last Update
October 17 2024
Active Locations (1)
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1
Universidad de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15785