- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06041919
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
A Phase 2 Study to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
Study Overview
Status
Intervention / Treatment
Detailed Description
A total of approximately 15 participants will be recruited per treatment arm (total of approximately 75 participants in the study). Control arm participants will be split across sequential stages stages 1 and 2, with no stratification.
Stage 1: To determine the EBA of
- Treatment Arm 1 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered three times daily over 14 days
- Treatment Arm 2 (Control; n= 5) - HRZE taken orally once daily
On completion of Stage 1, recruitment will be paused and an interim analysis performed to determine whether the study should proceed to Stage 2.
Stage 2: To determine the EBA of
- Treatment Arm 2 (Control; n= 10) - HRZE taken orally once daily
- Treatment Arm 3 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered once daily over 14 days
- Treatment Arm 4 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered twice daily over 14 days
- Treatment Arm 5 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily over 14 days
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Inva Hoti, PhD
- Phone Number: +44 (0) 1235 431 201
- Email: inva.hoti@30.technology
Study Locations
-
-
Bellville
-
Cape Town, Bellville, South Africa, 7531
- Recruiting
- Task Clinical Research Centre
-
Contact:
- Veronique De Jager, MD
- Phone Number: +27 21 100 3606
- Email: dr.veronique@task.org.za
-
Principal Investigator:
- Veronique De Jager, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provide written, informed consent prior to all study-related procedures and agree to undergo all study procedures
- Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive
- Newly diagnosed pulmonary TB
- Rifampicin susceptible pulmonary TB as determined by molecular testing
- Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 ml or more)
- Spirometry performed during screening with a FEV1 of ≥ 40%
- Be of non-childbearing potential or willing to use effective methods of contraception
Exclusion Criteria:
- HIV positive AND CD4 < 350 cells/mm3 OR are receiving antiviral therapy (ART)
- Methaemoglobin saturation (SpMet) >3%
- Female participant who is pregnant or breast-feeding
- Participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of IMP in the study
- Participation in other clinical studies with investigational agents within 8 weeks prior to screening
- Treatment received for this episode of TB with any drug active against M.tb
- Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
- Treatment with nitric oxide and other nitric oxide donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 (Active)
Inhaled RESP301 6ml via nebulisation three times daily
|
Nitric Oxide agent
|
Active Comparator: 2 (Control)
HRZE taken orally once daily
|
isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
Experimental: 3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
|
Nitric Oxide agent
|
Experimental: 4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
|
Nitric Oxide agent
|
Experimental: 5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once dialy
|
Nitric Oxide agent
isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Bactericidal Activity (EBA) of inhaled RESP301 measured as time to positivity (TTP)
Time Frame: 14 days
|
Overnight sputum collection from which viable mycobacteria in the sample is quantified as TTP
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Bactericidal Activity (EBA) of inhaled RESP301 measured as colony forming units (CFU)
Time Frame: 14 days
|
Overnight sputum collection from which viable mycobacteria in the sample is quantified as CFU
|
14 days
|
Safety and tolerability of inhaled RESP301 measured as incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 1.5 months
|
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death.
|
1.5 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESP30X-EBA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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