Detection of Mycobacterium Tuberculosis in Blood of TB Patients and Their Contacts in Uganda

NCT06751706 | Enrolling By Invitation

• 1 other identifier: IDI-REC-2023-80
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tuberculosis; Latent Tuberculosis

Keywords

Tuberculosis; Latent tuberculosis; TB; TB Infection; TB Biomarker; Blood test for TB

Outcome Measures

Primary Outcomes (1)

• Mtb DNA prevalence

  Prevalence of detectable Mtb in each group

  1 year

Secondary Outcomes (3)

• Mtb detection using alternative methods

  1 year

• Mtb DNA detection association with IGRA and RNA signatures for incipient TB

  1 year

• Strain correlation between index case and contact

  1 year

Study Arms (3)

Group A: TB patients

New diagnosis of smear-positive or Xpert-confirmed pulmonary TB

Group B: Recent TB contacts

Household contact with an index case of smear-positive pulmonary TB recruited to Group A.

Group C: Historical TB contacts

Participant in previous TB household contact study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 20 index cases of pulmonary TB (Group A) * 20 recent household contacts of Group A index cases * 20 historical TB contacts who previously participated in a TB household contact study

You may qualify if:

• 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

You may not qualify if:

• 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):
• 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.
• 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):
• Able and willing to give written informed consent to participate
• Age ≥18 years
• Participant in previous TB household contact study

Sponsors & Collaborators

• Queen Mary University of London: lead
• Makerere University: collaborator

Study Sites (1)

Infectious diseases institute, Makarere University

Kampala, P.O. Box 22418, Uganda

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood mononuclear cells

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Adrian Martineau, PhD

  Queen Mary University London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: September 30, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

UG (1)