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Efficacy of the Vacucis Candida® Autovaccine

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2024 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Apr 30, 2025 to Apr 30, 2026
    • Start date: Apr 30, 2024 to Apr 30, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v5
  2. Notable Primary completion date: Sep 1, 2024 to Apr 30, 2025
    • Start date: Sep 30, 2023 to Apr 30, 2024
    • Study completion date: Dec 31, 2024 to Dec 31, 2025
    v4
  3. Notable Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Start date: Sep 29, 2022 to Sep 30, 2023
    • Study completion date: Dec 31, 2023 to Dec 31, 2024
    v3
  4. Notable Primary completion date: May 1, 2022 to Sep 1, 2023
    • Start date: Mar 29, 2022 to Sep 29, 2022
    • Study completion date: Jul 1, 2022 to Dec 31, 2023
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works. Objective: To evaluate the reduction/suppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo. Material and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy. A descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p \< 0.05 will be considered significant.
Trial Details
NCT Number NCT05289375
Lead Sponsor University of Santiago de Compostela
Conditions
(from sponsor)
Oral Candidiasis, Oral Candidiasis Recurrent, Radiotherapy; Complications, Candida Albicans Infection, Microbial Colonization, Xerostomia
Related terms Candidiasis, Oral, Communicable Diseases, Xerostomia
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov