Trial · NCT07905235
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
NCT07905235, Not yet recruiting, Central South University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection. Trials, record NCT07905235. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07905235
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
- NCT number
- NCT07905235
- Status
- Not yet recruiting
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- Central South University
- Conditions
- Carbapenem-Resistant Acinetobacter Baumannii Infection
- Interventions
- Antibiotic Therapy for CRAB Infection
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07905235
GET https://conductscience.org/api/trials/v1/NCT07905235/registered