Summary of findings 2. Gatifloxacin‐containing 4‐month ATT regimens compared to standard 6‐month ATT regimens for drug‐sensitive pulmonary tuberculosis.

Gatifloxacin‐containing 4‐month ATT regimens compared to standard 6‐month ATT regimens for drug‐sensitive pulmonary tuberculosis
Patient or population: adults with drug‐sensitive pulmonary tuberculosis Setting: low‐ and middle‐income countries in sub‐Saharan Africa and India Intervention: gatifloxacin‐containing 4‐month ATT regimen Comparison: standard 6‐month treatment regimen
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
	Risk with 6‐month standard ATT	Risk with gatifloxacin‐containing 4‐month ATT
Relapse Follow‐up: 24 months	70 per 1000	77 more relapses per 1000 (32 more to 128 more)	RR 2.11 (1.56 to 2.84)	1633 (2 RCTs)	⊕⊕⊕⊝ MODERATEa,b Due to indirectness	The 4‐month regimen probably increases relapse compared to the 6‐month regimen
Death from any cause Follow‐up: 24 months	29 per 1000	3 fewer deaths per 1000 (14 fewer to 16 more)	RR 0.90 (0.53 to 1.53)	1886 (2 RCTs)	⊕⊕⊕⊝ MODERATEa,b,c Due to indirectness	The 4‐month regimen probably makes little or no difference in death compared to the 6‐month regimen
Treatment failure	25 per 1000	1 less treatment failure per 1000 (12 fewer to 18 more)	RR 0.93 (0.51 to 1.70)	1657 (2 RCTs)	⊕⊕⊝⊝ MODERATEa,b,c Due to indirectness	The 4‐month regimen probably makes little or no difference in treatment failure compared to the 6‐month regimen
Acquired drug resistance	12 per 1000	9 fewer with acquired drug resistance per 1000 (12 fewer to 49 more)	RR 0.24 (0.01 to 5.01)	301 (1 RCT)d	⊕⊝⊝⊝ VERY LOWb,e,f Due to indirectness, risk of bias, and imprecision	We do not know if acquired drug resistance is any different in the 4‐month and the 6‐month regimens
Serious adverse events	24 per 1000	0 fewer serious adverse events per 1000 (10 fewer to 18 more)	RR 1.02 (0.58 to 1.77)	1993 (2 RCTs)	⊕⊕⊕⊝ MODERATEa,b,c Due to indirectness	The 4‐month regimen probably results in little or no difference in serious adverse events compared to the 6‐month regimen
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ATT: anti‐tuberculosis treatment; CI: confidence interval; RCT: randomized controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

^aNo serious risk of bias: although Jawahar 2013 was assigned high risk of bias for allocation concealment, removal of this trial from the sensitivity analysis did not significantly alter the direction, magnitude, or precision of the effect estimate. Not downgraded.
 ^bDowngraded one level for serious indirectness: trials excluded children and adolescents and people with diabetes mellitus and other comorbid physical conditions and those with alcohol abuse.
 ^cNo serious imprecision: the 95% CI of the risk ratio was wide, but events were few and the sample size was reasonably large; the 95% CI for the absolute estimates did not indicate clinically appreciable benefits for either regimen. Not downgraded.
 ^dOne trial provided data on acquired drug resistance (Jawahar 2013). Merle 2014 reported only drug susceptibility at baseline.
 ^eDowngraded one level for serious risk of bias: allocation concealment was compromised and there were baseline imbalances in proportions with drug resistance at baseline in the sole trial for this outcome (Jawahar 2013).
 ^fDowngraded two levels for very serious imprecision: the data for acquired resistance come from only one trial with 301 participants, and this trial did not evaluate resistance to gatifloxacin.