Pulmonary Tuberculosis MedDRA version: 20.0 Level: PT Classification code 10044755 Term: Tuberculosis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: RUTI
Product Code: RUTI
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: RUTI
Current Sponsor code: RUTI
Other descriptive name: PURIFIED, PASTEURISED AND FREE
Sponsors
Archivel Farma S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: 1.Adults (females and males) aged = 18; 2.Written informed consent in a language they understand. This includes informed consent to be in the trial and informed consent to collect specimens 3.Laboratory confirmed pulmonary TB (with or without extrapulmonary involvement) defined as a hard copy of a sputum laboratory result that reports Mtb detection by sputum-microscopy smear-positive at least 1+, rapid molecular assay or mycobacterial culture. 4.Patients who have not received any anti-tubercular treatment in the last 24 hours 5.Females of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation); 6.Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control (i.e. diaphragm plus spermicide or male condom plus spermicide, oral contraceptive in combination with a second method, contraceptive implant, injectable contraceptive, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in the study; 7.Males must agree to use a double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide) at least 1 month after RUTI/placebo vaccination; or the male patient or his female partner must be surgically sterile (e.g. vasectomy, tubal ligation) or the female partner must be post-menopausal; 8.The patient must be willing and able to attend all study visits and comply with all study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential patient who meets any of the following criteria will be excluded from participation in this study: 1. Unable to provide written informed consent; 2. Women reported, or detected, or willing to be pregnant during the trial period; 3. Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4 4. Bodyweight 3 x upper limit of normal (ULN) • Total bilirubin > 2 x ULN • Neutrophil count = 500 neutrophils / mm3 • Platelet count < 50,000 platelets / mm3 10. Alcohol use: potential participant either self-reports or in the investigator’s opinion that the patient drinks more than an average of four units/day over a usual week or is a binge drinker (men: 5 or more drinks; women: consume 4 or more drinks, in about 2 hours) 11. Documented allergy to TB vaccines or any of the study treatment excipients, notably, to the RUTI® vaccine 12. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy as reduction of bacillary load through the study of early bactericidal activity (EBA);Secondary Objective: To evaluate the safety of the vaccine RUTI® (25 µg FCMtb) in patients with TB, when given concomitant with the SoC treatment initiation.;Primary end point(s): Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 0 and day 14 after treatment initiation and RUTI®/placebo vaccination.;Timepoint(s) of evaluation of this end point: Daily between day 0 and day 14 after treatment initiation and RUTI®/placebo vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 2 and day 14 after treatment. initiation and RUTI®/placebo vaccination. Difference between each intervention arm and control group. 2. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined daily between day 7 and day 14 after treatment initiation and RUTI®/placebo vaccination. 3. Early Bactericidal Activity (EBA) Measured as the reduction of bacillary load of M. Tuberculosis based upon Time to detection (TTD) signal in MGIT, determined at week 4, 8, 16 and 24 after treatment initiation and RUTI®/placebo vaccination. 4. Hazard ratio for stable culture conversion (SCC), [Time Frame: 24 weeks of TB treatment]. Difference between each intervention arm and control group. 5. Rate of Change in Time to Sputum Culture Positivity (TTP) in Liquid Culture Media (Days 0-14) [Time Frame: 14 days]. Difference between each intervention arm and control group. 6. Rate of Change in Time to Sputum Culture Positivity (TTP) in Liquid Culture Media (week 4, 8, 16 and 24 ) [Time Frame: up to week 24]. Difference between each intervention arm and control group. 7. The proportion of patients with AEs between each intervention arm and the control group [Time Frame: Up to week 24]. Difference between each intervention arm and control group. 8. The proportion of patients with SAEs between each intervention arm and the control group [Time Frame: Up to week 24]. Difference between each intervention arm and control group. 9. Proportion of patients with CLINICAL, X-ray or LABORATORY worsening [Time Frame: Entire study period]. Difference between each intervention arm and control group. 10. Proportion of patients with improvement of clinical signs and symptoms, Bandim Tb score [Time Frame: At we | — |
Countries
Spain
Contacts
Public ContactUnitat de Tuberculosi
Fundació Institut d'Investigació Germans trias i Pujo (IGTP)
Outcome results
None listed