An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensi… (NCT03557281) | Clinical Trial Compass
CompletedPhase 2
An Early Bactericidal Activity, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis
South Africa76 participantsStarted 2019-03-22
Plain-language summary
Tuberculosis remains a concerning health problem, with Mycobacterium Tuberculosis (MTB) now causing more deaths than acquired immune deficiency syndrome (AIDS). GSK3036656 is a compound with a novel mechanism of action under development for the treatment of tuberculosis. It suppresses protein synthesis in MTB by selectively inhibiting the enzyme Leucyl t-ribose nucleic acid (RNA) synthetase. Thus, this study will investigate the early bactericidal activity, safety and tolerability of GSK3036656 in up to four sequential cohorts of subjects with rifampicin-susceptible tuberculosis. The primary objective of this dose-escalation study is to establish the anti-tuberculosis effect of GSK3036656 on serial colony forming units (CFU) counts of MTB in sputum over 14 days of therapy. Subjects in each cohort will be randomized in 3:1 ratio to one of two treatments: either GSK3036656 or standard-of-care (RIFAFOUR® e-275) regimen. The approximate duration of the study for an individual subject will be 5 weeks, including 1 week of screening, 2 weeks of treatment period and another 2 weeks of final follow-up visit. RIFAFOUR e-275 is a registered trademark of Sanofi-Aventis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
* In addition, subjects recruited into cohorts that are planned to undergo fluorodeoxyglucose (FDG) positron emission tomography/ Computed Tomography (PET/CT) must be \>=25 years of age, at the time of signing the informed consent.
* New episode of untreated, rifampicin-susceptible pulmonary tuberculosis.
* A chest X-ray picture which in the opinion of the Investigator is consistent with tuberculosis.
* At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease/ World Health Organization \[IUATLD/WHO\] scale) or molecular test (Xpert MTB/ rifampicin) with result of either medium or high positive for MTB: Ability to produce an adequate volume of sputum as estimated from an overnight sputum collection sample (estimated 10 milliliter or more); estimated from a spot sputum sample at screening; confirmed at the first overnight collection; if less than 10 milliliter is collected overnight this may be repeated once.
* Normal echocardiogram or echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation and no valvular stenosis.
* Within the normal range for the assay for troponin and b-type natriuretic peptide at screening.
* Body weight (in light clothing and with no shoes) between 40 and 90 kilograms, inclusive, at screening.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in log10 Colony Forming Units (CFU) Per (/) Milliliter (mL) of Direct Respiratory Sputum Samples From Baseline to Day 14