A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens

Table 2 Association between MGIT culture results by primary outcome isolated positives on MGIT and LJ culture results, smear results and TB symptoms. Data restricted to culture results at or after week 33

Per protocol primary outcome	MGIT result	Paired smear result from same visit			Paired LJ result from same visit			Highest grade of TB symptom^a reported within 7 days of patient visit
Per protocol primary outcome	MGIT result	Negative	Positive	Total	Negative	Positive	Total	Absent or < Grade 1	Grade 1 (mild)	Grades 2–4	Total
Favourable	Negative	4659 (99%)	60 (1%)	4719	4456 (100%)	12 (<0.5%)	4468	3983 (85%)	453 (10%)	225 (5%)	4661
Favourable	Positive	148 (93%)	11 (7%)	159	132 (87%)	19 (13%)	151	131 (82%)	20 (13%)	8 (5%)	159
χ² test for independence				p < 0.0001			p < 0.0001				p = 0.481
Unfavourable	Negative	336 (93%)	26 (7%)	362	331 (98%)	8 (2%)	339	240 (69%)	69 (20%)	40 (11%)	349
Unfavourable	Positive	105 (25%)	309 (75%)	414	60 (15%)	336 (85%)	396	181 (45%)	116 (29%)	106 (26%)	403
χ² test for independence				p < 0.0001			p < 0.0001				p < 0.0001

^aTB symptom as reported on REMoxTB CRF including any one of the following seven: cough, haemoptysis, fever, night sweats, shortness of breath, chest pains, unintentional weight loss

ISSN: 1741-7015