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Table 1 Overview of included cohorts, number of participants and number of observations

From: Sputum lipoarabinomannan (LAM) as a biomarker to determine sputum mycobacterial load: exploratory and model-based analyses of integrated data from four cohorts

Cohort Name

NexGen EBA Cohorta

Biobank Sputum Specimen Cohort

Kawasaki Study Cohortsb

Cohort Type

Treatment

Clinical study NCT02371681a

Diagnostic

In vitro study using biobanked sputum samples

Diagnostic

Treatment

Participants (n)

178

250

308

40

Cohort Population

Adults with smear (+) pulmonary TB undergoing treatment for drug-susceptible TB

Adults suspected of pulmonary TB prior to treatment, and adult participants without TB

Adults suspected of pulmonary TB prior to treatment, and adult participants without TB

Adults with smear (+) pulmonary TB undergoing treatment for drug-susceptible TB

Treatment Regimen(s) (n)

Arm 1: Isoniazid (H) (22)

Arm 2: Rifampin (R) (22)

Arm 3: Pyrazinamide (Z) (22)

Arm 4: Moxifloxacin (M) (23)

Arm 5: R + Z (23)

Arm 6: H + Z (22)

Arm 7: MRZE (22)

Arm 8: HRZE (22)

Diagnostic (250)

Diagnostic (308)

Standard of care regimen:

Isoniazid (H), Rifampin (R), Pyrazinamide (Z), and Ethambutol (E): HRZE (40)

Duration (days)

14

Pre-treatment only

Pre-treatment only

56

Pharmacodynamic Response Measures (N)

1. AFB smear grade (Screening only)

2. CFU concentration (2323)

3. LAM concentration direct (439) and sediment (445)

4. MGIT-TTD (2459)

5. Xpert Cycle Threshold (Screening only)

1. AFB smear grade

2. Culture positivity (LJ media and MGIT [binary status])

3. LAM concentration direct (250)

1. AFB smear grade

2. Culture positivity (LJ media and MGIT [binary status])

3. LAM concentration direct (308) and sediment (308)

4. MGIT-TTD (271)

5. Xpert Cycle Threshold

1. AFB smear grade

2. LAM concentration direct (202) and sediment (175)

3. MGIT-TTD (180)

Sampling Daysc

Screening, Baseline, Day 7, and Day 13

Baseline (pre-treatment)

Baseline (pre-treatment)

Baseline, Day 3, Day 7, Day 14, Day 28, and Day 56

  1. AFB, acid-fast bacilli; CFU, colony-forming units; EBA, early bactericidal activity; FIND, Foundation for Innovative New Diagnostics; LAM, lipoarabinomannan; LJ, Löwenstein-Jensen; N, number of records; n, number of participants; MGIT, Mycobacterium Growth Indicator Tube; TTD, time to detection
  2. aNexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis. ClinicalTrials.gov (2017). Available at: https://clinicaltrials.gov/ct2/show/NCT02371681. (Accessed: 02 August 2017)
  3. bKawasaki M, Echiverri C, Raymond L, Cadena E, Reside E, Tarcela Gler M, et al. Lipoarabinomannan in sputum to detect bacterial load and treatment response in patients with pulmonary tuberculosis: analytic validation and evaluation in two cohorts. PLoS Med. 2019;16(4):e1002780
  4. cAdditional sampling timepoints were collected for CFU and MGIT-TTD in NexGen EBA Study: daily from Day 1 through Day 14