Summary of findings for the main comparison. Fluoroquinolone plus standard regimen compared to standard regimen alone for presumed drug‐sensitive TB.
| Fluoroquinolone plus standard regimen compared to standard regimen alone for drug‐sensitive TB | ||||||
| Patient or population: Patients with presumed drug‐sensitive TB Settings: New York and Hawaii Intervention: Fluoroquinolone plus standard regimen Comparison: Standard regimen alone | ||||||
| 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 alone | Fluoroquinolone plus standard regimen | |||||
| Treatment failure | ‐ | ‐ | ‐ | (0 studies) | ‐ | Not reported |
| Relapse | ‐ | ‐ | ‐ | (0 studies) | ‐ | Not reported |
| Death from any cause | 75 per 1000 | 20 per 1000 (2 to 185) | RR 0.27 (0.03 to 2.47) | 174 (1 study) | ⊕⊝⊝⊝ very low1,2,3 | |
| TB‐related death | 25 per 1000 | 20 per 1000 (1 to 310) | RR 0.80 (0.05 to 12.40) | 174 (1 study) | ⊕⊝⊝⊝ very low1,2,3 | |
| Sputum culture conversion at 8 weeks | 973 per 1000 | 954 per 1000 (885 to 1041) | RR 0.98 (0.91 to 1.07) | 174 (1 study) | ⊕⊕⊝⊝ very low2,4,5 | |
| Serious adverse events | 149 per 1000 | 127 per 1000 (60 to 265) | RR 0.85 (0.4 to 1.78) | 174 (1 study) | ⊕⊝⊝⊝ very low1,2,6 | |
| One or more adverse event | 172 per 1000 | 172 per 1000 (89 to 330) | RR 1 (0.52 to 1.92) | 174 (1 study) | ⊕⊝⊝⊝ very low1,2,7 | |
| *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: 73/174 (42%) of trial participants were excluded. 2 Downgraded by one for indirectness: This single trial was conducted in adults with and without HIV infection in New York and Hawaii over 15 years ago. The result may not be generalized to other situations. Levofloxacin was added to the standard regimen: 500 mg daily for two weeks (induction phase); then 750 mg levofloxacin thrice weekly for six weeks; then standard regimen only (continuation phase). 3 Downgraded by one for imprecision: This trial is underpowered to detect a statistically significant result. Only four deaths were reported: one in the intervention group and three in the controls. Of these only two were deemed to be due to TB; one in each group. 4 Downgraded by one for risk of bias: 73/174 (42%) of trial participants were excluded at eight weeks analysis. 5 Downgraded by one for imprecision: This trial remains underpowered to detect difference. The result is not statistically significant. 6 Downgraded by one for imprecision: This trial is underpowered to detect rare but important adverse effects. The adverse effects are described as: nausea, vomiting, peripheral neuropathy, dermatologic reactions with fever, haematological adverse events, renal or metabolic toxicity, and hepatic toxicity.