BridgeMD
New treatment option for Pulmonary Tuberculosis
Official title Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB
ClinicalTrials.gov ID: NCT06114628
What this study is testing
What is Ganfeborole?
Ganfeborole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary tuberculosis.
Also referred to as GSK3036656.
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
- The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the...
- Clinical evidence of active TB disease, meeting either or both of the following criteria:
- Symptoms consistent with pulmonary TB at screening AND/OR
- Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 7 days prior to screening
- At least one sputum specimen produced at screening tested on Xpert MTB/RIF Ultra that has:
You likely can't join if
- Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin...
- Known isoniazid resistance (at sites where national isoniazid monoresistance is greater than 10% rapid testing at screening is mandated; at other...
- Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion...
- Severe clinical pulmonary TB e.g. respiratory failure or complications likely to require hospital admission in the opinion of the investigator
- Poor general condition (Karnofsky score ≤50) OR where any delay in treatment cannot be tolerated in the opinion of the investigator
- Active malignancy requiring systemic therapy, radiotherapy or palliative therapy
See the full eligibility criteria
Who can join
- Age 18 years or above at screening (or above age of legal consent at screening, if this is higher than 18 years in the jurisdiction in which the study is taking place)
- Clinical evidence of active TB disease, meeting either or both of the following criteria:
- Symptoms consistent with pulmonary TB at screening AND/OR
- Imaging findings consistent with active pulmonary TB on chest X-ray performed at screening or within 7 days prior to screening
- At least one sputum specimen produced at screening tested on Xpert MTB/RIF Ultra that has:
- a semi-quantitative result of 'medium' or 'high' AND
- does not show rifampicin resistance
- Body weight within the range of 30 to 100kg and body mass index within the range of 15 to 40kg/m2
- Willing to comply with study visits, all study procedures and treatment observation
- Resident at a fixed address that is readily accessible for visiting, within feasible travelling distance to the site and likely to remain resident there for the duration of trial follow-up
- Has provided written informed consent
What rules you out
- Taken more than 1 daily dose of medication with anti-tuberculous activity during the 14 days prior to randomisation (isoniazid, rifampicin, pyrazinamide, ethambutol; linezolid, moxifloxacin, levofloxacin or amikacin)...
- Known isoniazid resistance (at sites where national isoniazid monoresistance is greater than 10% rapid testing at screening is mandated; at other sites rapid testing at screening is optional)
- Known or suspected extra-thoracic TB, miliary TB or disseminated TB (in the judgement of the investigator; note uncomplicated pleural effusion occupying \<50% of hemithorax or concomitant intra- or extra-thoracic...
- Severe clinical pulmonary TB e.g. respiratory failure or complications likely to require hospital admission in the opinion of the investigator
- Poor general condition (Karnofsky score ≤50) OR where any delay in treatment cannot be tolerated in the opinion of the investigator
- Active malignancy requiring systemic therapy, radiotherapy or palliative therapy
- History of myocardial infarction, coronary heart disease or congestive cardiac failure; long QT syndrome or clinically significant arrhythmias; pulmonary hypertension; any known congenital cardiac problems; family...
- Vitiligo
- History of seizure(s)
- Current tendinitis (any cause) or history of tendinopathy associated with fluoroquinolone use
- History of vascular aneurysm
- Symptomatic peripheral neuropathy causing greater than minimal interference with usual social and functional activities
- Current alcohol or illicit drug use sufficient to compromise the safety of the participant or research staff or compromise adherence to study procedures, in the opinion of the investigator
- Any current or recent use of amphetamines or methamphetamines, either reported or evident on toxicity screen, if performed
- Any other medically or socially significant condition (e.g. psychiatric illness, chronic diarrhoeal disease, metabolic condition, other cardiovascular disease not listed under criterion 7), that would, in the opinion of...
- Women who are currently pregnant or breast-feeding
- Women of childbearing potential unwilling or unable to use appropriate effective contraception during the study intervention period and for at least 14 days after the last dose of study intervention; and unwilling to...
- Men who are unwilling to use a condom during the study period and for at least 90 days after the last dose of study drug during any activity that allows for the passage of ejaculate to another person; and are unwilling...
- Known allergy to one or more of the study drugs
- Taking a concomitant medication that has a known or predicted interaction with any of the study drugs to which the participant might be assigned by chance. The participant need not be excluded if:
- the concomitant medication can be stopped or replaced with an alternative non-interacting medication, if needed AND
- the investigator judges there to be no residual clinical risk to the participant after stopping the concomitant medication (taking into account the washout period of 5x the half-life of the concomitant medication and...
- Taking a concomitant medication that is known to prolong the QTc interval. The participant need not be excluded if the concomitant medication can be stopped or replaced with an alternative medication, if needed, and the...
- Treatment with any immunosuppressive drugs within the 2 weeks prior to screening (taking systemic corticosteroids for less than 5 consecutive days and stopped at or prior to screening are not an exclusion; topical or...
- Participation in other clinical intervention trial with an investigational agent within 8 weeks prior to the first dosing day in this trial
- 12-lead ECGs at screening or at baseline shows QTcF \>450ms (men) or \>460ms (women) calculated by Fridericia's formula; and/or any other clinically significant abnormality such as arrhythmia or ischaemia
- Any of the following laboratory parameters at screening:
- Haemoglobin \< 9g/dl
- Platelet count \< 50 x 109 cells/L
- Absolute neutrophil count \<1000 cells/μL
- Creatinine clearance of \<75ml/min, calculated using Cockcroft-Gault equation\
- ALT or AST \> 3 times the upper limit of normal
- Total bilirubin \> 1.5 times upper limit of normal
- Serum potassium \<3.5 mmol/L (not excluded if corrected to above this level)
- Serum magnesium \< 0.70mmol/L (not excluded if corrected to above this level)
- Serum calcium (corrected for albumin level) \< 2.10 mmol/L (not excluded if corrected to above this level)
- Hepatitis B surface antigen positive (known, or on a test performed at screening)
- HIV antibody positive (known, or on test performed at screening)\
- Known Hepatitis C virus infection (unless also known to have negative PCR test)\
The study team makes the final eligibility decision.
Where it's taking place
- Chisinau, Moldova
- Cape Town, South Africa
- George, South Africa
- Mbeya, Tanzania
- Moshi, Tanzania
- Mwanza, Tanzania
- Kampala, Uganda
- Hanoi, Vietnam
- Ho Chi Minh City, Vietnam
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chisinau, Moldova; Cape Town, South Africa; George, South Africa; Mbeya, Tanzania; Moshi, Tanzania; Mwanza, Tanzania and 3 more location(s). 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.