Table 1 Baseline characteristics in the intention-to-treat population, including TT genotype

From: Genotype-stratified adjunctive dexamethasone for tuberculous meningitis in HIV-negative adults: a randomized controlled phase 3 trial

Characteristic

N

All participants (N = 702)

CC and CT genotype (N = 613)

TT genotype (N = 89)

Treatment

702

 

Dexamethasone (N = 305)

Placebo (N = 308)

Dexamethasone (N = 89)

Age (years)

702

47 (33–59)

48 (35–60)

46 (33–58)

42 (28–59)

Male sex

702

435 (62.0%)

192 (63.0%)

191 (62.0%)

52 (58.4%)

LTA4H CC genotype

702

291 (41.5%)

146 (47.9%)

145 (47.1%)

–

LTA4H CT genotype

702

322 (45.9%)

159 (52.1%)

163 (52.9%)

–

Diagnostic category

702

–

–

–

–

Definite

–

312 (44.4%)

128 (42.0%)

139 (45.1%)

45 (50.6%)

Probable

–

241 (34.3%)

107 (35.1%)

108 (35.1%)

26 (29.2%)

Possible

–

149 (21.2%)

70 (23.0%)

61 (19.8%)

18 (20.2%)

Confirmed non-TBM

–

0 (0%)

0 (0%)

0 (0%)

0 (0%)

Modified MRC severity grade

702

–

–

–

–

Grade I

–

298 (42.5%)

134 (43.9%)

132 (42.9%)

32 (36.0%)

Grade II

–

342 (48.7%)

150 (49.2%)

151 (49.0%)

41 (46.1%)

Grade III

–

62 (8.8%)

21 (6.9%)

25 (8.1%)

16 (18.0%)

Glasgow coma score

698

15 (13–15)

15 (13–15)

15 (13–15)

14 (11–15)

Duration of symptoms (days)

702

15 (12–21)

15 (11–22)

15 (11–21)

16 (12–20)

Cranial nerve palsy

702

86 (12.3%)

36 (11.8%)

39 (12.7%)

11 (12.4%)

Hemiplegia

702

76 (10.8%)

35 (11.5%)

26 (8.4%)

15 (16.9%)

Paraplegia/tetraplegia

702

125 (17.8%)

52 (17.0%)

56 (18.2%)

17 (19.1%)

CSF parameters

–

–

–

–

–

Total leucocytes (cells per cubic millimeter)

702

136 (33–326)

127 (31–309)

143 (35–349)

129 (33–294)

Protein (g l−1)

702

1.5 (0.9–2.2)

1.4 (0.9–2.2)

1.5 (0.9–2.3)

1.5 (1.0–2.2)

CSF/blood glucose ratio

701

0.37 (0.25–0.49)

0.37 (0.27–0.47)

0.37 (0.24–0.51)

0.38 (0.23–0.48)

CSF microbiological tests

–

–

–

–

–

Positive ZN stain

702

153 (21.8%)

68 (22.3%)

65 (21.1%)

20 (22.5%)

Positive GeneXpert MTB/RIF

702

102 (14.5%)

45 (14.8%)

44 (14.3%)

13 (14.6%)

Positive GeneXpert MTB/RIF Ultraa

702

116 (16.5%)

46 (15.1%)

58 (18.8%)

12 (13.5%)

Positive mycobacterial culture

702

175 (24.9%)

77 (25.2%)

72 (23.4%)

26 (29.2%)

Duration of antituberculosis chemotherapy before enrollment (days)

700

3.0 (1.0–4.0)

3.0 (1.0–4.0)

3.0 (1.0–4.0)

2.0 (2.0–4.0)

  1. aXpert Ultra availability varied between sites and over time but only became more widely available for the last 12 months of the study, hence its relatively restricted use. N is the number of participants included in that statistic. The summary statistic is the median (first and third quartile) value for continuous data, and the number and frequency (%) of participants with the characteristic for categorical data. Definite TBM is defined as positive acid-fast bacilli on CSF Ziehl-Neelsen stain, or positive CSF GeneXpert test, or positive CSF mycobacterial culture. Probable or possible TBM was defined following uniform case definition26. Confirmed non-TBM indicates microbiologically confirmed other brain infection. Confirmed additional brain infection includes positive CSF India Ink stain, CSF cryptococcal antigen, positive blood cryptococcal antigen, positive CSF bacterial Gram stain, positive CSF bacterial culture or positive CSF viral or helminth PCR test. Xpert, Gene Xpert MTB/RIF; ZN, Ziehl-Neelsen.
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