Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB) (NCT04919239) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)
India140 participantsStarted 2021-09-22
Plain-language summary
Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts upon completion of 1 week of standard DS-TB treatment (cohort A), and another cohort of patients will be vaccinated upon completion of 1 month of standard MDR-TB treatment (cohort B). All the patients will be followed up to the end of the treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Diagnosed with pulmonary DS- or MDR-TB, and managed with standard-care TB drugs accordingly;
✓. Attending a TB unit / hospital routinely diagnosed with pulmonary DS- or MDR-TB with clinical status ≥ 6 with Bandim TB score combined with chest radiography; and microbiological criteria (MGIT sputum culture), by using rapid genetic testing, gene Xpert;
✓. Patients who have not received any anti-tubercular treatment in last 6 months
✓. Females and males aged ≥ 18;
✓. The patient must provide written informed consent;
✓. The patient must be willing and able to attend all study visits and comply with all study procedures.
Exclusion criteria
✕. Inability to provide written informed consent;
✕. Women reported, or detected, or willing to be pregnant during the trial period;
✕. Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
✕. Patients with extra-pulmonary tuberculosis
✕. Major co-morbid conditions precluding full evaluation, i.e., HIV positive, chronic renal failure, chronic liver failure, Malignancy, patients taking any immunosuppressant drug, active lung cancer, acute coronary syndrome, heart failure exceeding NYHA class 2;
What they're measuring
1
Percentage of patients with Sputum Culture Negative
Timeframe: Up to Week 2 for Cohort A and Month 1.5 for Cohort B