Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02774993
Eligibility Criteria:
Healthy Volunteers 10 volunteers will be recruited comprising 5 females and 5 males.
Inclusion criteria:
1. No known medical conditions
2. Aged 21 years to less than 70.
Exclusion criteria:
1. Unable to give informed consent
2. Prisoners
3. Pregnancy or nursing
4. On medication or oral contraceptives
5. Any concurrent illness, such as influenza
TB patients
Inclusion criteria: Patients should meet all criteria
1. Patients receiving ≤ 7 days of TB treatment or about to start standard combination TB treatment
2. Confirmed pulmonary TB with positive acid-fast bacilli smear and/or positive TB GeneXpert test and/or culture results
3. Chest radiograph demonstrating pulmonary involvement
4. Aged 21 years to less than 70
Exclusion criteria:
1. HIV co-infection
2. Previous pulmonary TB
3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, Chronic obstructive pulmonary disease and lung cancer
4. Pregnant or breast feeding
5. Allergies to tetracyclines
6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity
7. Autoimmune disease and/or on systemic immunosuppressants
8. Unable to provide informed consent
9. Haemoglobin \< 8 g/dl
10. Creatinine 2 times upper limit of normal (ULN)
11. Alanine transaminase \>3 times ULN
12. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period
13. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung
14. Evidence of severe depression, schizophrenia or mania
15. Principal investigator assessment of lack of willingness to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT02774993
Study Brief:
Protocol Section:
NCT02774993