Pulmonary Tuberculosis Pulmonary Tuberculosis, Biomarker
Conditions
Interventions
Suspected Tuberculosis patient, male or female, age greater than or equal to 18 years old,Healthy participants, male or female, age greater than or equal to 18 years old
Basic Science,Basic Science
TB group,Healthy patticipants
Sponsors
Mahidol-Oxford Translation Innovation Partmnership (MOTIP)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: TB group 1. Male or female, age greater than or equal to 18 years old 2. Participant will be presented with signs and symptoms suggestive of pulmonary TB, including persistent cough lasting greater than or equal to 2 weeks and at least one of either fever, malaise, recent weight loss, night sweats, knowledge of close contact with pulmonary TB patient, hemoptysis, chest pain or loss of appetite. 3. Read and understand study related material intended for subject 4. Provide a signed and dated written informed consent 5. Participant with underlying illness including HIV can be enrolled Healthy participant group 1. Male or female, age greater than or equal to 18 years old. Health status determined by Investigator based on medical history and screening examinations. 2. Read and understand study related material intended for subject 3. Provide a signed and dated written informed consent
Exclusion criteria
Exclusion criteria: TB group 1. Females who are pregnancy or lactation 2. Received anti-TB treatment before sample collection. 3. Cannot collect sputum specimen 4. Lack of suitability for participation in this study, for any reason, in the opinion of the investigator. Healthy participant group 1. Female who are pregnancy or lactation 2. History of chronic hypertension, cardiac disease, diabetes mellitus, liver diseases, renal diseases, symptomatic or asymptomatic arrhythmias. 3. AST or ALT greater than 1.5 ULN 4. A creatinine clearance (CrCl) less than 70 mL/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine neopterin profile pattern from TB participants Day 60-90 Liquid chromatography with mass spectrometry,Urine LAM concentration -TB group Day 60-90 Enzyme-linked immunosorbent assay,Urine 2 aminobutyric acid profile pattern from TB participants Day 60-90 Liquid chromatography with mass spectrometry,Saliva Neopterin profile pattern from TBparticipants Day 60-90 Liquid chromatography with mass spectrometry,Saliva LAM concentration from Tb group Day 60-90 Enzyme-linked immunosorbent assay,Saliva 2 aminobutyric acidprofile pattern from TB participants Day 60-90 Liquid chromatography with mass spectrometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine neopterin concentration from TB and healthy participant groups Day 0 Liquid chromatography with mass spectrometry,Urine LAM concentration from TB and healthy participant groups Day 0 Enzyme-linked immunosorbent assay,Urine 2-aminobutyric acid concentration from TB and healthy participant groups Day 0 Liquid chromatography with mass spectrometry,Saliva neopterin concentration from TB and healthy participant groups Day 0 Liquid chromatography with mass spectrometry,Saliva LAM concentration from TB and healthy participant groups Day 0 Enzyme-linked immunosorbent assay,Urine 2-aminobutyric acid concentration from TB and healthy participant groups Day 0 Liquid chromatography with mass spectrometry | — |
Countries
Thailand
Contacts
Public ContactWarunee Hanpithakpong
Mahidol Oxford Tropical Medicine Research Unit
Outcome results
None listed