Summary of findings for the main comparison. Moxifloxacin compared to amoxicillin‐clavulanate for NSTI.
| Moxifloxacin compared to amoxicillin‐clavulanate for NSTI | ||||||
| Patient or population: NSTI Setting: hospital Intervention: moxifloxacin Comparison: amoxicillin‐clavulanate | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality/certainty of the evidence (GRADE) | Comments | |
| Risk with Amoxicillin‐clavulanate | Risk with Moxifloxacin | |||||
| Mortality follow‐up: 30 days | Study population | RR 3.00 (0.39 to 23.07) | 54 (1 RCT) | ⊕⊝⊝⊝ Very lowa | Data from a larger trial including several types of soft tissue infections; total number of included patients N = 804 | |
| 6 per 100 | 17 per 100 (2 to 100) | |||||
| Serious adverse events (SAE) follow‐up: 28 days | Study population | RR 0.63 (0.30 to 1.31) | 54 (1 RCT) | ⊕⊝⊝⊝ Very lowa | Description of nature of serious adverse events was not available | |
| 44 per 100 | 28 per 100 (13 to 58) | |||||
| Survival time | — | — | — | 54 (1 RCT) | ⊕⊝⊝⊝ Very lowa | The median time of death after start of antibiotic treatment was shorter in the moxifloxacin group than in the amoxicillin‐clavulanate group (10.5 days versus 42 days) (not possible to calculate hazard ratio with the data provided) |
| Assessment of long‐term morbidity | — | — | — | — | — | Not reported |
| *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). Assumed risk for mortality was based on data of the literature (Audureau 2017; May 2009). For serious adverse effects it was based on the results of the trial. CI: Confidence interval; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High quality/certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality/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 quality/certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality/certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded by five levels to very low certainty of evidence. We downgraded two levels because of high risk of bias regarding blinding (open label trial) and high risk for attrition bias because of a high rate of withdrawal (20%). We downgraded one level for serious imprecision because of small sample size (and CI of RR included 1, where reported). We downgraded a further two levels because no clear criteria for clinical diagnosis of necrotizing fasciitis were provided and because antibiotic used as comparator is not relevant (indirectness)