TRIPOD (INA-102) : Tuberculosis Research of INA-RESPOND On Drug Resistance

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.

TRIPOD SITES Ver 2

Associated Publications:

  • Characteristics of Drug-sensitive and Drug-resistant Tuberculosis Cases among Adults at Tuberculosis Referral Hospitals in Indonesia. Am J Trop Med Hyg. 2022 Oct 17;107(5):984-991. doi: 10.4269/ajtmh.22-0142. PMID: 36252800.
  • Performance of Xpert MTB/RIF and sputum microscopy compared to sputum culture for diagnosis of tuberculosis in seven hospitals in Indonesia. Front Med (Lausanne). 2023 Jan 20;9:909198. doi: 10.3389/fmed.2022.909198. PMID: 36743681.
  • Treatment outcomes of pulmonary TB in adults in Indonesia. IJTLD Open. 2025 Mar 12;2(3):145-152. doi: 10.5588/ijtldopen.24.0482. PMID: 40092521.

Associated Biorepository

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