TABLE 4.
Summary of knowns and gaps of knowledge
| Category | Description |
|---|---|
| Knowns | Mechanism of action |
| Mechanisms of resistance | |
| Pharmacokinetics | |
| Spectrum of activity | |
| Safety and tolerability of short-term duration | |
| Efficacy for FDA-labeled indications | |
| Dosing regimen for FDA-approved indications | |
| Target populations for FDA-approved indications | |
| Susceptibility testing methodology | |
| Combination therapy (in vitro data) | |
| Breakpoints available for limited organisms | |
| Unknowns/limited knowledge | Efficacy and safety for off-label indications |
| Optimal dosing for off-label indications | |
| Role and timing in therapy (initial, salvage, consolidation) | |
| Impact on microbiome | |
| Type and accessibility of susceptibility testing techniques | |
| Definition and assessment of tolerance | |
| Combination therapy (in vivo or clinical data) | |
| Efficacy against multidrug-resistant pathogens | |
| PK/PD targets | |
| Selection of resistance and mutant selection window | |
| Clinical impact of tolerance, resistance, and cross-resistance | |
| Cost-effectiveness | |
| Safety and tolerability for long-term duration | |
| Appropriate follow-up | |
| Accessibility of susceptibility testing | |