Summary of findings 2. Fluoroquinolone substitution for ethambutol in a standard six month regimen compared to standard regimen for presumed drug‐sensitive TB.
| Fluoroquinolone substitution for ethambutol in a standard six month regimen compared to standard regimen for drug‐sensitive TB | ||||||
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Patient or population: Patients with presumed drug‐sensitive TB
Settings: Brazil, North America, Africa, and South Africa
Intervention: Fluoroquinolone substitution for ethambutol in a standard six month regimen (fluoroquinolones + HRZ) 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 ethambutol | |||||
| Treatment failure | ‐ | ‐ | ‐ | (0 studies) | ‐ | Not reported |
| Relapse | 66 per 1000 | 47 per 1000 (11 to 202) | RR 0.71 (0.17 to 3.06) | 170 (1 study) | ⊕⊝⊝⊝ very low1,2,3 | |
| Death from any cause | 32 per 1000 | 17 per 1000 (7 to 42) | RR 0.52 (0.21 to 1.32) | 723 (3 studies) | ⊕⊕⊝⊝ very low1,4,5,6 | |
| TB‐related death | 16 per 1000 | 5 per 1000 (0 to 129) | RR 0.33 (0.01 to 8.07) | 170 (1 study) | ⊕⊝⊝⊝ very low1,2,6 | |
| Sputum culture conversion at 8 weeks | 704 per 1000 | 753 per 1000 (683 to 838) | RR 1.07 (0.97 to 1.19) | 723 (3 studies) | ⊕⊕⊝⊝ very low1,4,5,7 | |
| Serious adverse events | 65 per 1000 | 60 per 1000 (34 to 105) | RR 0.93 (0.53 to 1.62) | 723 (3 studies) | ⊕⊕⊝⊝ very low1,4,5,8 | |
| One or more adverse events | ‐ | ‐ | ‐ | (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. All three trials were considered at high risk of bias due to high levels of exclusions from the final analysis. 2 Downgraded by one for indirectness: Only a single trial comparing moxifloxacin with ethambutol assessed this outcome. It was conducted in adults in Brazil between 2004 and 2007 and is not easily generalized to other fluoroquinolones or populations. 3 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. 4 No serious inconsistency: None of three trials found a statistically significant difference. 5 No serious indirectness. Moxifloxacin, gatifloxacin, and ofloxacin have been compared to ethambutol and moxifloxacin in three trials, and gatifloxacin and ofloxacin in one trial each. These were conducted in adults from Brazil (between 2004 and 2007), North America, and Africa (dates not given), and South Africa (between 2004 and 2005). 6 Downgraded by two for imprecision: Only 14 deaths were reported in the three trials. Only Conde 2009 reported on TB‐related death and only one occurred. Much larger trials would be necessary to show an effect. 7 Downgraded by one for imprecision. CIs of two of three studies are wide and studies remain underpowered. 8 Downgraded by one for imprecision. All three trials were underpowered to detect difference and CIs are wide.