Table 2. Baseline characteristics template table.
| Characteristic | Dexamethasone
(N=…) |
Placebo
(N=…) |
||
|---|---|---|---|---|
| N | Summary statistic | N | Summary statistic | |
| Age (years) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Sex – male | XX | XX (XX%) | XX | XX (XX%) |
| Site
- HTD - PNT |
XX XX |
XX (XX%) XX (XX%) |
XX XX |
XX (XX%) XX (XX%) |
|
Leukotriene A4 hydrolase
- TT - CT - CC |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
XX XX |
XX (XX%) XX (XX%) |
| Diagnostic category
*
- Definite TBM - Probable TBM - Possible TBM - Not TBM |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
| Previous tuberculosis treatment | XX | XX (XX%) | XX | XX (XX%) |
| Chest X-ray findings
- No tuberculosis - Miliary tuberculosis - Pulmonary tuberculosis |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
| Modified MRC grade
- Grade I - Grade II - Grade III |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
| Glasgow coma score | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Weight (kg) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Duration of symptoms (days) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Neurological signs
- Cranial nerve palsy - Hemiplegia - Paraplegia/tetraplegia - Urinary retention |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
| History of diabetes | XX | XX (XX%) | XX | XX (XX%) |
| HbA1c (%) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Hepatitis B sAg positivity, | XX | XX (XX%) | XX | XX (XX%) |
| Hepatitis C Ab positivity | XX | XX (XX%) | XX | XX (XX%) |
| Alanine aminotransferase (ALT) (IU/L) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Bilirubin (µmol/L) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Full blood count
- Haemoglobin (g/dL) - White cell count (x10 3/ µL) - Platelets (x10 3/ µL) |
XX XX XX |
XX (XX,XX) XX (XX,XX) XX (XX,XX) |
XX XX XX |
XX (XX,XX) XX (XX,XX) XX (XX,XX) |
| Plasma sodium (mmol/L) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| CSF parameters
- Opening pressure (cmH 20) - Total leucocytes (cells/mm 3) - Total neutrophils (cells/mm 3) - Total lymphocytes (cells/mm 3) - Protein (g/L) - CSF:blood glucose |
XX XX XX XX XX XX |
XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) |
XX XX XX XX XX XX |
XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) XX (XX,XX) |
| CSF microbiological tests
- Positive ZN stain - Positive GeneXpert MTB/RIF - Positive GeneXpert MTB/RIF Ultra - Positive mycobacterial culture |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
| Duration of anti-tuberculosis chemotherapy before enrolment (days) | XX | XX (XX,XX) | XX | XX (XX,XX) |
| Enrolment anti-tuberculosis chemotherapy regimen
- Rifampicin - Isoniazid - Pyrazinamide - Ethambutol - Streptomycin |
XX XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
XX XX XX XX XX |
XX (XX%) XX (XX%) XX (XX%) XX (XX%) XX (XX%) |
| Anti-tuberculosis drug resistance
#
- Multi-drug resistant or rifampicin mono-resistant - Isoniazid resistant non-MDR - No or other resistance |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
XX XX XX |
XX (XX%) XX (XX%) XX (XX%) |
* Participants will only be categorised as ‘not TBM’ if they have a confirmed alternative diagnosis (alternative to TBM) or if they fully recovered without any anti-TB drugs. #Results given for sub-group with positive mycobacterial culture on baseline CSF. N = number of patients included in that statistic. Summary statistic = the median (1 st and 3 rd quartile) value for numeric data, and the number and frequency (%) of patients with the characteristic for categorical data.
Definite TBM = positive acid fast bacilli (AFB) on CSF Ziehl Neelsen stain, or positive CSF TB GeneXpert test, OR positive CSF TB culture. Probable or possible TBM defined following uniform case defintion 12 , with the modification that participants with score<6, who do not meet the criteria for ‘not tuberculous meningitis’, will be classifed as ‘possible TBM’. Confirmed not-TBM = microbiologically confirmed other brain infection. Confirmed additional brain infection includes positive CSF India Ink stain, or CSF cryptococcal antigen, or positive blood cryptococcal antigen, or positive CSF bacterial Gram stain, or positive CSF bacterial culture, or positive CSF viral or helminth PCR test.
HTD=Hospital for Tropical Diseases. MDR=multi-drug resistant. MRC=Medical Research Council. PNT=Pham Ngoc Thach Hospital for Tuberculosis and Lung Disease. TBM=tuberculous meningitis. ZN=Ziehl Neelsen.