BridgeMD
Tests treatment safety and results for Pulmonary Tuberculoses
Official title Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of RESP30TB in Tuberculosis
ClinicalTrials.gov ID: NCT07073638
What this study is testing
What is RESP30TB?
RESP30TB is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for pulmonary tuberculoses.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial 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).
You likely can't join if
- HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART)
- Baseline Methaemoglobin saturation (SpMet) \>3%.
- Female patients who is pregnant or breast-feeding.
- Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the...
- 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
See the full eligibility criteria
- Provide written, informed consent prior to all trial-related procedures and agree to undergo all trial 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 Forced Expiration Volume in the first second (FEV1) of ≥ 40%.
- Be of non-childbearing potential or willing to use effective methods of contraception, as defined in section 4.3.4.
- HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART)
- Baseline Methaemoglobin saturation (SpMet) \>3%.
- Female patients who is pregnant or breast-feeding.
- Patients planning to conceive a child within the anticipated period of trial participation and for at least 90 days after the last dose of IMP in the trial.
- 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 NO and other NO donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Cape Town, Bellville, South Africa
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cape Town, Bellville, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.