Trial · NCT03869437
RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI
NCT03869437, Phase 2, Completed, The University of Queensland
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI. Trials, record NCT03869437. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03869437
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI
- NCT number
- NCT03869437
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 513 participants, actual
- Lead sponsor
- The University of Queensland
- Conditions
- Bloodstream Infections
- Interventions
- Cefiderocol, Best Available Therapy
- First posted
- 2019-03-11
- Last updated
- 2024-02-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality at 14 days | 14 days post date of randomisation | To compare the 14-day mortality from day of randomisation of each regimen (cefiderocol versus standard of care therapy). If the primary objective meets the criteria for non-inferiority (with a margin of 10% for the difference in proportions), superiority will be examined. |
| Secondary | Mortality post blood stream infection of each regimen at longer time points | 30 and 90 days, from day of randomisation or "day 1" | If a date of death is recorded on or before our calculation of Day 14, the participant will be classed as dead, otherwise considered to be alive. Similar for Day 30. Where possible this rule will also be applied for Day 90 vital status. If the Day 90 follow-up actually occurred on day 85 to 89 and the participant was alive we will assume the participant was alive at day 90. |
| Secondary | Clinical and microbiological failure at day 14 | Day 14, from day of randomisation or "day 1" | Defined as composite of: 1. Death 2. Still in hospital and clinical failure, as defined by 1. If baseline SOFA ≥3, D(day)14 SOFA not improved by ≥30% 2. If baseline SOFA \<3, D14 SOFA worse 3. Microbiological failure (GNB Growth in blood of same species as index GNB from days 3-14) The SOFA score we will calculate is a slight modification of the original SOFA score. It will be used for ICU and non-ICU participants. The sole modification is that the respiratory component will be scored as in the modified SOFA: * 0 (if SaO2/FiO2 \>400) * 1 (if SaO2/FiO2 315-400) * 2 (if SaO2/FiO2 235-314) * 3 (if SaO2/FiO2 150-234) * 4 (if SaO2/FiO2 \<150) |
| Secondary | Microbiological failure days 3 to 90 post randomisation | Day 3 through to day 90 | Defined as growth in blood cultures of the same GNB as the index blood culture(s), from day 3 up to day 90. |
| Secondary | Colonisation or infection with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), carbapenem-resistant Gram-negative bacilli or Candida bloodstream infection. | Day 3 through to day 90 | Defined as the presence of MRSA, VRE or carbapenem-resistant Gram-negative bacilli (of a different species from primary BSI organism) on culture +/- molecular test of clinical samples or screening swabs, or Candida species grown in blood cultures from day 3 up to day 90. |
| Secondary | Clostridioides difficile infection days 3 to 90 post randomisation. | Day 3 through to day 90 | Defined as presence of a compatible clinical illness with a positive laboratory stool test for C. difficile (as per local diagnostic protocol / method). |
| Secondary | Improvement in functional status at day 30 post randomisation compared to baseline. | Day 30, from day of randomisation or "day 1" | Functional status will be measured according to a score ranging from 0 (dead) to 7 (out of hospital, healthy, able to complete daily actvities). This score is based on the Functional Bloodstream Infection Score (FBIS) \[McNamara et al. Clin Microbiol Infect. 2020 Feb;26(2):257.e1-257\]. |
| Secondary | Time to hospital discharge. | From day of randomisation or "day 1" through to day 90 | Defined as to the day of first discharge alive (e.g. Day 2 is the day after randomisation). However, if a participant dies in the 3 days following first hospital discharge, we will consider that participant as not having a discharge alive. |
| Secondary | Treatment emergent SAEs (Serious Adverse Events) | From day of randomisation or "day 1" through to 5 days post end of study treatment. | Defined as a serious adverse event possibly, probably or definitely related to the randomised drug treatment. |
Source ClinicalTrials.gov
Outcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03869437
GET https://conductscience.org/api/trials/v1/NCT03869437/registered