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

Launched by QUEEN MARY UNIVERSITY OF LONDON · Dec 27, 2024

Keywords

ClinConnect Summary

This study in Kampala, Uganda is trying to find out whether fragments of Mycobacterium tuberculosis (the bacteria that cause TB) can be detected in the blood of people who have active TB and their household contacts. Researchers will test blood with several lab methods to see how often Mtb DNA can be found and whether this detection relates to certain immune tests and to the bacteria’s drug-resistance patterns. They will also compare the TB strains found in the blood to those in the patient’s lungs. The study is observational (not testing a therapy) and will follow participants for about one year.

Who can join: Adults 18 and older who can give informed consent. The groups include: Group A—people newly diagnosed with active pulmonary TB (smear-positive or Xpert-confirmed) and at least one asymptomatic adult household contact; Group B—the adult household contacts of Group A; Group C—historical TB contacts who previously took part in a related study. Key exclusions include having taken anti-TB treatment for more than 7 days, pregnancy, or other medical conditions that might affect safety. Participants will provide a blood sample (to study PBMCs) and may be followed for up to a year. The study is currently enrolling and aims to enroll about 60 people, with an estimated completion in 2026. Sponsored by Queen Mary University of London with Makerere University collaboration.

Gender

ALL

Eligibility criteria

• 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)
• • Existing medical condition which in the opinion of the investigator may adversely affect the participant's safety or ability to participate in the study.