NCT06751706Enrolling by invitation
Detection of Mycobacterium Tuberculosis in Blood of TB Patients and Their Contacts in Uganda
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 20 Dec 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Queen Mary University of London
- Diseases
- Tuberculosis
- NCT number
- NCT06751706
What you commit to
- Study type: Observational
- Planned participants: 60
- From 30 Sept 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous anti-TB treatment
- Current or previous anti-TB treatment
Other illness
- 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):
- 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):
- Existing medical condition which in the opinion of the investigator may adversely affect the participant's safety or ability to participate in the study.
Other
- More than 7 days of anti-TB treatment taken
- Confirmed or suspected pregnancy (female participants)
- Clinical or radiological features of active TB
- Confirmed or suspected pregnancy (female participants)
- Clinical or radiological features of active TB
- Confirmed or suspected pregnancy (female participants)
Who the study is looking for
- 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
- 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.
- Able and willing to give written informed consent to participate
- Age ≥18 years
- Participant in previous TB household contact study
Criteria the registry did not label
- TB patients (Group A):
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infectious diseases institute, Makarere University Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.