Summary of findings 3. Fluoroquinolone substitution for isoniazid in a standard six month regimen compared to standard regimen for presumed drug‐sensitive TB.
| Fluoroquinolone substitution for isoniazid in a standard six month regimen compared to standard regimen for presumed drug‐sensitive TB | ||||||
|
Patient or population: Patients with presumed drug‐sensitive TB
Settings: North America, Brazil, South Africa, Spain, Uganda
Intervention: Fluoroquinolone substitution for isoniazid in a standard six month regimen Comparison: Standard regimen (HRZE) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Standard regimen | Fluoroquinolone substitution for isoniazid | |||||
| Treatment failure | ‐ | ‐ | ‐ | (0 studies) | ‐ | not reported |
| Relapse | ‐ | ‐ | ‐ | (0 studies) | ‐ | not reported |
| Death from any cause | 24 per 1000 | 18 per 1000 (4 to 79) | RR 0.75 (0.17 to 3.30) | 433 (1 study) | ⊕⊕⊝⊝ low1,2 | |
| TB‐related death | 6 per 1000 | 12 per 1000 (1 to 131) | RR 2 (0.18 to 21.84) | 433 (1 study) | ⊕⊕⊝⊝ low1,2 | |
| Sputum culture conversion at 8 weeks | 549 per 1000 | 604 per 1000 (500 to 730) | RR 1.10 (0.91 to 1.33) | 433 (1 study) | ⊕⊕⊝⊝ low1,3 | |
| Serious adverse events | 37 per 1000 | 41 per 1000 (16 to 104) | RR 1.1 (0.43 to 2.8) | 433 (1 study) | ⊕⊕⊝⊝ low1,4 | |
| One or more adverse event | ‐ | ‐ | ‐ | (0 studies) | ‐ | not reported |
| *The basis for the assumed risk (eg the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1 Downgraded by one for risk of bias. 105/433 (24.3%) participants were excluded from the final analysis. 2 Downgraded by one for imprecision: The result is not statistically significant and the 95% CI is wide. This study was underpowered to detect an effect. Only seven deaths occurred and three were deemed related to TB. 3 Downgraded by one for imprecision: this single trial remains underpowered to detect an effect. The result is not statistically significant and the 95% CI is wide. 4 Downgraded by one for imprecision: The result is not statistically significant and the 95% CI is wide. This single study was underpowered to detect an effect. Only 14 serious adverse events occurred and they were equally distributed between comparison groups.