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. 2024 Apr 2;14:7793. doi: 10.1038/s41598-024-58200-w

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.