Table 2 Inclusion and exclusion criteria
Inclusion criteria | ||
|---|---|---|
A. All participants | ||
• 18–65 years old | ||
• Weight > 35 kg and < 120 kg | ||
• HIV negative | ||
• Willing and able to comply with study procedures | ||
• No known current systemic infections (apart from active TB for group 1) | ||
• Agree to have a bronchoscopy performed | ||
• Agree to undergo a PET-CT | ||
• Agree to have a chest x-ray done | ||
• Have a verifiable address | ||
B1. TB cases (A + B1) | B2. Contacts (A + B2) | B3. Controls (A + B3) |
• No history of previous active TB within the last 3 years (3 years since completion of TB treatment) • TB diagnosis confirmed by the following: Smear positive OR GeneXpert® positive medium, high, or very high OR GeneXpert® positive lower than medium (i.e., trace, very low or low positive) plus symptoms suggestive of active PTB or a chest x-ray suggestive of PTB | • Contacts of newly diagnosed active pulmonary TB patients or participants who have shared the same home, work, or recreational space as the index case for at least 3 months prior to TB diagnosis and for at least 5 h per week in the same room • Negative GeneXpert® • No symptoms or signs suggestive of active TB—unintentional weight loss, drenching night sweats, coughing for 2 or more weeks, hemoptysis | • Member of the community who does not have close contact to a patient or participant with active pulmonary TB and who self does not have active TB • Negative GeneXpert® • No symptoms or signs suggestive of active TB—unintentional weight loss, drenching night sweats, coughing for 2 or more weeks or hemoptysis |
C. SARS-CoV-2 positive groups (A + B1/B2/B3 + C) | ||
• Participants who test positive for SARS-CoV-2 on a validated serologic test, regardless of previous symptoms | ||
• Participants who have previously tested positive for SARS-CoV-2 on respiratory specimen PCR or antigen testing, as per the Western Cape Provincial case definition | ||
Exclusion criteria | ||
|---|---|---|
A. All participants | ||
• Pregnant (current or in the last 6 months) or breastfeeding | ||
• No permanent address | ||
• Hb < 9 g/dl | ||
• HIV infection | ||
• Planned relocation or pending criminal cases potentially leading to incarceration during the duration of the study | ||
• Diabetes mellitus as defined by random glucose ≥ 11.1 mmol/l (or ≥ 200 mg/dl), fasting plasma glucose ≥ 7.0 mmol/l (≥ 126 mg/dl), point of care HbA1c ≥ 6.5, or the use of any anti-diabetic agent (including traditional medicines) as a concomitant medicine | ||
• Use of any immunosuppressive drugs within the last 4 weeks | ||
• Any severe systemic condition/co-morbidity that may affect the safety of the participant or the performance of the assays, including (but not limited to) uncontrolled diabetes, cancer, uncontrolled hypertension, or ischemic heart disease | ||
• Any person for whom the physician/study nurse feels this study is not appropriate for, or that the study is not in the person’s best interest, e.g., a history of substance or alcohol abuse that may interfere with the participant’s adherence to study procedures | ||
• History of taking any TB medication in the past 4 weeks | ||
• Known allergy or intolerance to components of FDG or drugs used in procedural sedation | ||
• A known history or family history of malignant hyperthermia | ||
B1. TB positive cases (A + B1) | B2. Contacts (A + B2) | B3. Controls (A + B3) |
• Already started TB treatment • Resistance of TB strain to TB medication • Evidence of or suspected extra-pulmonary TB (based on clinical judgement or confirmed by microbiological studies or radiologically) Participants with a TB pleural effusion will be included provided that the effusion is small to moderate in size and there is overt evidence of parenchymal involvement on the chest radiograph • History of previous active Mtb disease/TB treatment within the last 3 years | • Previous active Mtb disease • Any microbiological evidence of current active TB disease (positive GeneXpert®/smear/culture) | • Previous active Mtb disease • Any microbiological evidence of current active TB disease (positive GeneXpert®/smear/culture) • History of contact with a patient with active TB in the last 12 months • Chest X-ray evidence of chronic lung disease or active TB |