Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 20 of 20

List	Outcome	Time frame	Description
Primary	28-Day All-Cause Mortality Rate	From the first administration of a study-defined intravenous anti-CRAB antibiotic (Day 0) through Day 28.	The proportion of participants who die from any cause within 28 days after the first administration of a study-defined intravenous anti-CRAB antibiotic (Day 0). Survival status will be determined using hospital medical records and follow-up assessments when necessary. The primary comparison will be between patients receiving polymyxin-based and sulbactam-based initial treatment strategies.
Secondary	Clinical Cure Rate at Day 14	At Day 14 after treatment initiation, with an assessment window from Day 12 to Day 16.	The proportion of participants achieving clinical cure of the index CRAB infection at Day 14. Clinical cure is defined as resolution of infection-related symptoms, clinical signs, oxygenation or hemodynamic abnormalities, and inflammatory markers, or their return to pre-infection levels, without the need for continued or escalated targeted anti-CRAB therapy. Clinical response will be classified as cure, improvement, failure, or not evaluable.
Secondary	Clinical Success Rate at Day 14	At Day 14 after treatment initiation, with an assessment window from Day 12 to Day 16.	The proportion of participants achieving clinical success, defined as either clinical cure or clinical improvement at Day 14. Clinical improvement is defined as a substantial improvement from Day 0 in infection-related clinical findings without escalation, addition, or switching of targeted anti-CRAB therapy because of inadequate infection control. Treatment modifications due to toxicity, intolerance, drug availability, cost, renal function changes, or de-escalation after clinical cure will not automatically be classified as clinical failure. Death before the assessment time point will be classified as clinical failure.
Secondary	Microbiological Clearance Rate	Day 7 and Day 14 after Day 0, and on the date of the end of treatment (EOT)(Day 28)	The proportion of microbiologically evaluable participants achieving microbiological clearance of CRAB from eligible infection-site specimens. Clearance is defined as the first negative follow-up culture without subsequent recovery of CRAB through the end of treatment. Two consecutive negative cultures will be additionally classified as confirmed microbiological clearance. Participants without an eligible follow-up culture will be classified as not evaluable rather than microbiologically cleared.
Secondary	Incidence of New-Onset Acute Kidney Injury	From treatment initiation through Day 28.	Proportion of microbiologically evaluable participants with a negative CRAB culture and no subsequent positive culture through the end of treatment. Two consecutive negative cultures will be classified as confirmed clearance.
Secondary	Maximum Acute Kidney Injury Stage	From treatment initiation through Day 28.	Highest stage of acute kidney injury observed during follow-up, classified as Stage 1, 2, or 3 according to KDIGO 2012 criteria using serum creatinine, reliable urine output, and renal replacement therapy data.
Secondary	Incidence of New Renal Replacement Therapy	From treatment initiation through Day 28.	Proportion of participants without acute kidney injury at baseline who develop acute kidney injury during follow-up, assessed according to Kidney Disease: Improving Global Outcomes (KDIGO) 2012 criteria in the prespecified evaluable population.
Secondary	Incidence of Adverse Events	From treatment initiation through Day 28.	Proportion of participants not receiving renal replacement therapy at baseline who require initiation of renal replacement therapy during the observation period.
Secondary	Ventilator-Free Days Within 28 Days	During the first 28 days after treatment initiation.	Number of days participants are alive and free from invasive mechanical ventilation during the first 28 days after treatment initiation. Participants who die within 28 days will be assigned zero ventilator-free days.
Secondary	Intensive Care Unit-Free Days Within 28 Days	During the first 28 days after treatment initiation	Number of days participants are alive and not receiving care in an intensive care unit during the first 28 days. Participants who die within 28 days will be assigned zero intensive care unit-free days.
Secondary	Duration of Targeted Antibiotic Therapy	From treatment initiation through Day 28	Total number of days of study-defined targeted anti-CRAB antibiotic treatment received during the observation period, based on actual medication administration records.
Secondary	Total Direct Inpatient Medical Costs	From treatment initiation through Day 28	Total direct medical costs incurred during the index hospitalization within 28 days after treatment initiation, including antibiotics, intensive care, organ support, laboratory tests, diagnostic procedures, and management of adverse events. Costs will be reported in Chinese yuan.
Secondary	Incremental Cost-Effectiveness Ratio	From treatment initiation through Day 28	Incremental cost-effectiveness ratio comparing polymyxin-based and sulbactam-based initial treatment strategies, calculated as the adjusted difference in mean direct medical costs divided by the adjusted difference in 28-day survival probability. The result will be expressed in Chinese yuan per additional 28-day survivor.
Secondary	Hospital-Free Days Within 28 Days	From Day 0 through Day 28.	The number of days participants are alive and outside the hospital during the first 28 days after initiation of targeted anti-CRAB antibiotic therapy (Day 0). Participants who die within 28 days will be assigned zero hospital-free days.
Secondary	Intensive Care Unit Length of Stay	From Day 0 through Day 28.	The cumulative number of days participants spend in the intensive care unit (ICU) during the 28-day observation period after initiation of targeted anti-CRAB antibiotic therapy. ICU length of stay will be calculated using hospital admission, transfer, and discharge records.
Secondary	Total Hospital Length of Stay	From Day 0 through Day 28.	The total number of days participants spend in the hospital during the 28-day observation period, including intensive care unit and general ward stays. Hospital length of stay will be determined from hospital admission, discharge, and transfer records.
Secondary	Targeted Antibiotic Costs	From Day 0 through Day 28.	The cumulative direct costs of targeted anti-CRAB antibiotics administered during the index hospitalization within 28 days after treatment initiation. Costs will be calculated from actual medication administration and hospital billing records and reported in Chinese yuan (CNY).
Secondary	Incidence of Clinically Significant Liver Injury	From Day 0 through Day 28.	The proportion of participants developing new-onset or clinically significant worsening of liver injury after initiation of targeted anti-CRAB antibiotic therapy. Clinically significant liver injury is defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of normal (ULN), alkaline phosphatase (ALP) ≥2 times ULN with evidence of hepatic origin, or ALT or AST ≥3 times ULN accompanied by total bilirubin ≥2 times ULN. Baseline liver abnormalities and alternative causes will be considered when assessing treatment-emergent events and drug relatedness.
Secondary	Incidence of Neurotoxicity	From Day 0 through Day 28.	The proportion of participants experiencing new-onset neurological adverse events during the observation period, including sensory disturbances, dizziness, muscle weakness, ataxia, altered consciousness, myoclonus, seizures, neuromuscular blockade, or respiratory muscle weakness. Event severity and potential relationships to antibiotic treatment will be assessed by investigators. Neurological status that cannot be reliably evaluated will be documented.
Secondary	Incremental Net Monetary Benefit	From Day 0 through Day 28.	The incremental net monetary benefit (INMB) of polymyxin-based treatment compared with sulbactam-based treatment, calculated as the willingness-to-pay threshold per additional 28-day survivor multiplied by the adjusted difference in 28-day survival probability, minus the adjusted difference in mean direct medical costs. INMB will be evaluated across prespecified willingness-to-pay thresholds and reported in Chinese yuan (CNY).

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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