Table 2.
Definitions employed in the publications included for evaluating clinical cure, microbiological eradication, treatment failure and/or improvement in clinical status.
| Author and year of publication | Definitions of outcomes |
|---|---|
| De Waele et al. 201315 |
Clinical resolution: disappearance of all signs and symptoms associated with infection Improvement: marked or moderate reduction in severity and/or number of signs and symptoms of infection Failure: insufficient lessening of signs and symptoms of infection to qualify as improvement, including death Microbiological eradication: response to therapy was also evaluated by bacterial persistence on day 7 |
| Fournier et al. 201822 |
Clinical cure: ND Improvement: ND Failure: ND Microbiological eradication: ND |
| Hagel et al. 202216 |
Resolution: disappearance of signs and symptoms and no addition of antimicrobial therapy and no requirement for additional antibiotic treatment (except as part of de-escalation strategy) for the disease to be examined AND no initiation of antibiotic treatment for the disease to be investigated within 48 h after completion of the study drug Improvement: marked to moderate improvement in signs and symptoms and no addition of antimicrobial therapy and no initiation of antimicrobial therapy in 48 h after cessation of antibiotics Failure: signs and symptoms of infection persist or increase in comparison to baseline, or additional antibiotic treatment becomes necessary for the disease to be investigated Microbiological eradication: documented: elimination of the putative pathogen from repeated cultures of the site of infection presumed: disappearance of acute signs and symptoms related to the infection and no culture results available |
| Fournier et al. 201520 | ND |
| McDonald et al. 201617 |
Resolution: antibiotic cessation due to microbiological control or de-escalation to narrower spectrum antibiotic triggered by clinical improvement and new microbiology data Treatment failure: escalation of antibiotic therapy with additional agents |
| Aldaz et al. 202118 |
Clinical remission: absence of all signs and symptoms suggestive of infection including the normalization of temperature, C-reactive protein (CRP) and procalcitonin (PCT) levels in the absence of known sepsis markers. Normal CRP and PCT levels were defined ≤ 0.5 mg/L and ≤ 0.5 ng/mL, respectively Microbiological remission: cultures with no bacterial growth |
| Nikolas et al. 202121 | ND |
| Kunz Coyne et al. 202219 |
Clinical cure: absence of all-cause in-hospital mortality, escalation and/or addition of antimicrobial therapy for Pseudomonas aeruginosa infection after 48 h of treatment due to worsening clinical status or transfer to a higher level of care Microbial eradication: eradication of P. aeruginosa from the index positive culture source up to hospital discharge when confirmed by ≥ 1 repeat culture. In cases where there were no repeated cultures and the patient had infection resolution, microbial eradication was assumed |
Other outcomes are clarified in Table 1. ND, not defined in the publication specified.