ClinicalTrials.gov: NCT02758236
Collaborator: NIAID, NIH
Status: Completed
https://clinicaltrials.gov/study/NCT02758236
The TRIPOD observational study enrolled 490 adults with suspected pulmonary tuberculosis between February 2017 and November 2018. Participants presented with a persistent cough for 2 weeks, a chest x-ray suggestive of tuberculosis, and at least one other tuberculosis-related symptom. Demographic, clinical, and laboratory data were collected at enrollment and during follow-up visits. Most participants (53.1%) had no history of tuberculosis, and most (53.5%) had successful outcomes at the end of standard treatment according to national guidelines. Each participant underwent concurrent sputum testing by acid-fast bacilli smear, GeneXpert MTB/RIF, and Mycobacterium culture. Among the 490 participants, 99 were diagnosed with clinical tuberculosis without bacteriological confirmation and 348 had tuberculosis that was bacteriologically-confirmed by all tests (77.3%), two tests only (15.2%), or one test only (7.5%). Phenotypic drug susceptibility testing was performed on 312 culture isolates, identifying 154 (49.4%) with varying levels of drug resistance.

| Specimen Type | Visit | New TB Cases | Previously Treated TB Cases | ||||
| Clinical TB | DS-TB | DR-TB | Clinical TB | DS-TB | DR-TB | ||
| Whole Blood | M0 | 62 | 144 | 44 | 28 | 56 | 98 |
| Paxgene Blood RNA | M0 | 57 | 130 | 40 | 29 | 50 | 79 |
| M1 | 31 | 121 | 37 | 15 | 42 | 73 | |
| M2 | 28 | 106 | 28 | 10 | 32 | 60 | |
| End | 12 | 90 | 24 | 8 | 22 | 42 | |
| PBMC | M0 | 50 | 126 | 41 | 28 | 45 | 79 |
| M1 | 25 | 107 | 35 | 14 | 34 | 62 | |
| M2 | 22 | 104 | 28 | 9 | 28 | 58 | |
| End | 7 | 63 | 12 | 3 | 16 | 22 | |
| EDTA Plasma | M0 | 61 | 145 | 44 | 30 | 56 | 99 |
| M1 | 31 | 121 | 36 | 14 | 42 | 72 | |
| M2 | 28 | 116 | 31 | 9 | 36 | 70 | |
| End | 12 | 102 | 28 | 7 | 26 | 54 | |
| Serum | M0 | 58 | 145 | 44 | 28 | 56 | 99 |
| Sputum | M0 | 13 | 75 | 31 | 16 | 29 | 77 |
| M1 | 10 | 36 | 22 | 8 | 12 | 51 | |
| M2 | 7 | 26 | 20 | 5 | 10 | 49 | |
| End | 2 | 18 | 17 | 4 | 6 | 41 | |
| Isolate from sputum | M0 | N/A | 139 | 39 | N/A | 55 | 95 |
| M1 | N/A | 2 | 1 | N/A | 5 | 1 | |
| M2 | N/A | N/A | N/A | N/A | N/A | 2 | |
| Saliva | M0 | 53 | 137 | 43 | 26 | 55 | 96 |
| End | 13 | 96 | 27 | 8 | 25 | 56 | |
| Urine | M0 | 66 | 149 | 44 | 31 | 56 | 99 |
| M1 | 32 | 124 | 37 | 15 | 42 | 73 | |
| M2 | 29 | 117 | 32 | 10 | 37 | 74 | |
| End | 14 | 101 | 28 | 9 | 26 | 56 | |