Table 1—

Comparison of the TBNET cohort(Migliori et al. 1) and the present (Udwadia) cohort

VariablesTBNET cohortUdwadia cohort
Study design RetrospectiveProspective
Time of study 2001–20072004–2007
Setting Centres: multicentre; 21 participating centres in Belarus, Germany, Italy and SwitzerlandSingle centre: the chest outpatient department of a single, large, private, tertiary referral hospital in Mumbai, India
Sample size 195 subjects78 subjects
Mean age of patients yrs Not mentioned29 yrs
Sex Not mentioned36 male, 42 female
Linezolid arm 85 out of 195 patients18 out of 78 patients
MDR-TB 41 (91.1%) out of 4511 (61.1%) out of 18
XDR-TB 4 (8.9%) out of 457 (38.8%) out of 18
Methodology Retrospective, nonrandomised, unblinded, study evaluating the safety and tolerability of linezolid at 600 mg, once a day or twice a day, in MDR-/XDR-TB treatment. Efficacy evaluation compared end-points of 45 linezolid-treated against 110 linezolid-nontreated casesProspective, nonrandomised addition of linezolid to the treatment regimes of 78 consecutive MDR- and XDR-TB patients to assess outcome and safety, 18 of whom received linezolid
Linezolid dosage 600 mg once a day in 28 patients, 600 mg twice a day (1200 mg·day−1) in 57 patients600 mg once a day in all patients
Linezolid administration time 32 weeks20.6 months
Regimen used IndividualisedIndividualised
Treatment outcome in linezolid group Cured: n = 11; treatment failure: n = 4; lost to follow-up: n = 3
 Mean sputum smear conversion102 days
 Mean culture conversion109 days
 Cured23 subjects
 Completed13 subjects
 Death9 subjects
 Failure0 subjects
Efficacy end-points (sputum conversion) 600 mg q.d., 10 (71.4%) out of 14; 600 mg b.i.d., 21 (67.7%) out of 31Data on time to sputum smear and culture conversion are not available due to financial constraints.
Sputum smear conversion 600 mg q.d., 13 (92.9%) out of 14
Culture conversion 600 mg b.i.d., 26 (83.9%) out of 31
Safety (adverse effects) 600 mg q.d., 4 (14.3%) out of 28; 600 mg b.i.d., 23 (40.4%) out of 57600 mg q.d., 11 (61%) out of 18
Time duration after which the adverse effects occurred After 60 days of treatmentWithin 1–3 months
Main adverse effect Anaemia in 44%Peripheral neuropathy in 38.88%
Conclusions Risk of adverse effects but safer dosage could be prescribed without losing the potential benefits; use for only the most complicated MDR/XDR-TB cases 5Linezolid proved to be effective but highly toxic in Indian patients with MDR/XDR-TB. This warrants extreme caution when this drug is used for prolong periods of time in MDR/XDR-TB patients
  • TBNET: Tuberculosis Network European Trials; MDR-TB: multidrug-resistant tuberculosis; XDR-TB: extensively drug-resistant tuberculosis.