Fully sensitive multidrug-resistant tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Inhaled RESP301 (via a nebuliser)
The total study duration for a participant from screening to the last follow-up will be a maximum of 90 days or as per continuation phase appointment under routine c
Sponsors
Thirty Respiratory Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hospitalised patients with: 1. Smear, culture or DNA probe-proven pulmonary tuberculosis 2. On approved guideline-based treatment (subject to drug sensitivity) 3. Age =18 years of age 4. Able to give written informed consent 5. Able to understand instructions 6. Able to operate and maintain nebuliser, as assessed by the Investigator
Exclusion criteria
Exclusion criteria: 1. Concomitant severe respiratory disease such as severe asthma and severe COPD with predicted FEV1 <40% 2. Any current or previous condition/circumstance that, in the opinion of the investigator, may put the individual at risk 3. Unable to tolerate the use of a nebuliser for approximately 8-10 minutes as required by the study, according to the Investigator’s opinion 4. Any unstable, uncontrolled, or severe medical condition that in the opinion of the investigator would make the participant unsuitable for the trial 5. Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives, whichever is longer 6. Known allergy/hypersensitivity to, or relevant drug-drug interaction with, the study drug/components of the study drug 7. History of methaemoglobinaemia 8. Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial 9. Prescribed nitric oxide donating agents (e.g. nitroprusside, isosorbide dinitrate, isosorbide mononitrate, naproxcinod, molsidomine and linsidomine)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of RESP301 in terms of total counts and cumulative incidence and relatedness of: 1. Adverse Events (AEs) 2. Serious Adverse Events (SAEs) 3. Suspected Unexpected Serious Adverse Reactions (SUSARs) 4. Severe AEs AEs recorded for the duration of the study): at Screening (Day -1) to Day 90 (or at early termination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of RESP301 in terms of changes in the colony count of Mycobacterium tuberculosis in the sputum following administration of RESP301; measured using a sputum sample at Screening (Day -1), Baseline (Day 1), Day 2 and Day 7 (end of treatment/or early withdrawal if earlier) | — |
Countries
England, United Kingdom
Outcome results
None listed