Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

Launched by ARCHIVEL FARMA S.L. · Jul 8, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a new vaccine called RUTI for patients with pulmonary tuberculosis (TB). The goal is to see if this vaccine can help the body fight off active TB bacteria as well as those that are in a dormant state, which are harder to treat with antibiotics. By boosting the immune system, the RUTI vaccine may help patients recover faster without causing antibiotic resistance, a problem where bacteria become resistant to treatment.

To participate in this study, individuals need to be at least 18 years old and have a confirmed diagnosis of pulmonary TB. Women must not be pregnant and should use effective contraception during the trial. Participants will need to attend several study visits and follow specific guidelines. It's important to note that those with certain health conditions, such as severe respiratory issues or HIV, may not be eligible. If you or a loved one is interested in this trial, it can be a chance to contribute to research that could improve TB treatment for everyone.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18 or older
• • Written informed consent
• • Laboratory confirmed pulmonary TB
• • Clinical symptoms compatible with pulmonary TB and/or X-ray evidence of pulmonary TB
• • Women of non-childbearing potential: at least 2 years post-menopausal or surgically sterile (e.g. tubal ligation)
• • Women of childbearing potential (including women less than 2 years past menopause) must have a negative pregnancy test at enrollment and must agree to use dual-barrier methods of contraception, intrauterine device (IUD), bilateral tubal occlusion, sexual abstinence, or vasectomized partner.
• • Males must agree to use a double barrier method of contraception at least 1 month after RUTI/placebo vaccination; or the male patient or his female partner must be surgically sterile or the female partner must be post-menopausal
• • Willing and able to attend all study visits and comply with all study procedures
• • Verifiable address or place of residence easy accessible to perform visits and willing to inform the research team of any change during the treatment and follow-up period
• Exclusion Criteria:
• • Unable to provide written informed consent
• • Women reported, or detected, or willing to be pregnant during the trial period; Men willing to conceive a child during the study or 6 months after end of treatment
• • Severity of illness precluding full evaluation: expected early death, evidenced by respiratory failure, low blood pressure, WHO performance score 3-4
• • Evidence or suspicion of resistance to rifampin, isoniazid, pyrazinamide, and ethambutol, either laboratory-confirmed or based on epidemiological history at screening
• • Previous treatment for M. tuberculosis in the previous 24 months.
• • Bodyweight \< 40kg
• • Unstable Diabetes Mellitus as a poor metabolic control within the past 12 months
• • HIV-infected subjects
• • Major co-morbid conditions or any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results
• • HIstory of severe mental ilness which, in the opinion of the investigator, may exclude the participant from participating in the trial.
• * Any of the following laboratory parameters:
• • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x upper limit of normal (ULN)
• • Total bilirubin \> 2 x ULN
• • Neutrophil count ≤ 500 neutrophils / mm3
• • Platelet count \< 50,000 platelets / mm3
• • 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)
• • Known allergy or any hipersensitivity to study mediactions, including rifampin, isoniazid, pyrazinamide, and ethambutol, or any of its excipients.
• • Documented allergy to anti-TB vaccines or any excipient of the RUTI vaccine.
• • 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