Detection of Mycobacterium Tuberculosis in Blood of TB Patients and Their Contacts in Uganda (NCT06751706) | Clinical Trial Compass
By InvitationNot Applicable
Detection of Mycobacterium Tuberculosis in Blood of TB Patients and Their Contacts in Uganda
Uganda60 participantsStarted 2024-09-30
Plain-language summary
Mycobacterium tuberculosis (Mtb) is a major human pathogen, responsible for an estimated 10.6 million cases of active tuberculosis (TB) and 1.6 million deaths in 2021. Most adult cases of active TB arise from progression of latent tuberculosis infection (LTBI), whose global prevalence is estimated at 23%. Preventive therapy (e.g. a 6-month course of the anti-TB drug isoniazid) is effective in reducing risk of progression from LTBI to active TB. Global roll-out of preventive therapy will be required to achieve the World Health Organization target of TB elimination by 2050, but this will only be cost-effective and implementable if targeted at the 10-20% of latently infected individuals who are at highest risk of disease progression.
There is currently no gold standard test for LTBI. Existing diagnostic - the tuberculin skin test (TST) and Interferon-γ Release Assays (IGRA) - diagnose Mtb infection by detecting memory T cell responses to Mtb antigens. Their value is limited by very low positive predictive value (PPV) for progression to active TB (1.5% for TST, 2.7% for IGRA), inability to detect antimicrobial resistance in latently infected individuals and lack of response to administration of preventive therapy. Development of a nucleic acid amplification test (NAAT) for LTBI could overcome these limitations by allowing targeting of preventive therapy at latently infected individuals with the highest risk of progression to active TB, with antimicrobial selection guided by genetic antimicrobial resistance profiling and capacity for test of cure on treatment completion.
Who can participate
Age range
18 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.
TB patients (Group A):
Inclusion Criteria:
* Able and willing to give written informed consent to participate
* Age ≥18 years
* New diagnosis of smear-positive or Xpert-confirmed pulmonary TB
* At least one asymptomatic adult household contact likely to fulfil TB contact eligibility criteria below
Exclusion criteria:
* More than 7 days of anti-TB treatment taken
* Confirmed or suspected pregnancy (female participants)
* Existing medical condition which in the opinion of the investigator may adversely affect the participant's safety or ability to participate in the study.
Recent TB contacts (Group B):
Inclusion Criteria:
* Able and willing to give written informed consent to participate
* Age ≥18 years
* Household contact with an index case of smear-positive pulmonary TB in Group A above.
Exclusion Criteria:
* Clinical or radiological features of active TB
* Current or previous anti-TB treatment
* Confirmed or suspected pregnancy (female participants)
* Existing medical condition which in the opinion of the investigator may adversely affect the participant's safety or ability to participate in the study.
Historical TB contacts (Group C):
Inclusion Criteria:
* Able and willing to give written informed consent to participate
* Age ≥18 years
* Participant in previous TB household contact study
Exclusion Criteria:
* Clinical or radiological features of active TB
* Current or previous anti-TB treatment
* Confirmed or suspected pregnancy (female participants)
* Existin…
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.