Trial · NCT02714595
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
NCT02714595, Phase 3, Completed, Shionogi; results first posted 2020-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens. Trials, record NCT02714595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02714595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
- NCT number
- NCT02714595
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 152 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Healthcare-associated Pneumonia (HCAP), Bloodstream Infections (BSI), Hospital Acquired Pneumonia (HAP), Complicated Urinary Tract Infection (cUTI), Sepsis, Ventilator Associated Pneumonia (VAP)
- Interventions
- Cefiderocol, Best Available Therapy
- First posted
- 2016-03-21
- Last updated
- 2021-01-12
- Other registries' IDs
- eudract:2015-004703-23
- Results first posted
- 2020-12-17
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. Participants with missing data were considered as non-responders. |
| Primary | Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21 | Microbiological outcome per Baseline pathogen was determined by the sponsor as defined for each infection site. For cUTI eradication was defined as a urine culture that showed that the Gram-negative uropathogen identified at Baseline at ≥ 10⁵ colony-forming units (CFU)/mL was reduced to \< 10³ CFU/mL. Overall per-participant eradication was defined as eradication of all Baseline Gram-negative pathogens. |
| Secondary | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | End of treatment, Day 7 to 14 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Clinical cure was defined as resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. |
| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy was required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy was required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. |
| Secondary | Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. |
| Secondary | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI | End of treatment, Day 7 to 14 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. |
| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. |
| Secondary | Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | End of treatment, Day 7 to 14 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. |
| Secondary | Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. HAP/VAP/HCAP: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia including a reduction in SOFA and CPIS scores, and improvement or lack of progression of chest radiographic abnormalities such that no antibacterial therapy was required for the treatment of the current infection. BSI/Sepsis: Resolution or substantial improvement of Baseline signs and symptoms including a reduction in SOFA score, such that no antibacterial therapy was required for the treatment of BSI/sepsis. Participants with bacteremia must have eradication of bacteremia caused by the Gram-negative pathogen. cUTI: Resolution or substantial improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, such that no antibacterial therapy is required for the treatment of the current infection. |
| Secondary | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms and was defined for each diagnosis. Sustained clinical cure for HAP/VAP/HCAP: Continued resolution or substantial improvement of Baseline signs and symptoms of pneumonia, such that no antibacterial therapy is required for the treatment of pneumonia in a participant assessed as cured at TOC. BSI/Sepsis: Continued resolution or substantial improvement of Baseline signs and symptoms associated with reduction in SOFA score, such that no antibacterial therapy is required for the treatment of the original BSI/sepsis in a participant assessed as cured at TOC. cUTI: Continued resolution or improvement of Baseline signs and symptoms of cUTI, or return to pre-infection Baseline if known, in a participant assessed as cured at TOC. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Carbapenem-resistant Microbiological Intent-to-treat (CR Micro-ITT) Population included all participants who received at least 1 dose of the study treatment, who had a baseline Gram-negative pathogen from an appropriate clinical specimen, and whose baseline Gram-negative pathogen was carbapenem-resistant as confirmed by central laboratory testing. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | Test of cure, defined as 7 days after the end of treatment, equivalent to Study Days 14 to 21 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | End of treatment, Day 7 to 14 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were counted as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Cure at Follow-up (FU) in Participants With HAP/VAP/HCAP or BSI/Sepsis | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at Test of Cure in Participants With cUTI | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With cUTI | End of treatment, Day 7 to 14 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered as non-responders | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With cUTI | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Carbapenem-resistant Microbiological Intent-to-treat Population); participants with missing data were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at End of Treatment in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | End of treatment, Day 7 to 14 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Cure at Test of Cure in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Test of cure, defined as 7 days after end of treatment, equivalent to Study Day 14 to 21 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Cure at Follow-up in Participants With HAP/VAP/HCAP + BSI/Sepsis, and Overall | Follow-up, defined as 14 days after the end of treatment, equivalent to Study Day 21 to 28 | Carbapenem-resistant Microbiological Intent-to-treat Population; participants with missing data were considered non-responders. | percentage of participants | NUMBER |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group612
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | HAP/VAP/HCAP: Cefiderocol | 50.0 | 95% Confidence Interval 33.8 to 66.2 | percentage of participants | |
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | HAP/VAP/HCAP: Best Available Therapy | 52.6 | 95% Confidence Interval 28.9 to 75.6 | percentage of participants | |
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | BSI/Sepsis: Cefiderocol | 43.5 | 95% Confidence Interval 23.2 to 65.5 | percentage of participants | |
| Percentage of Participants With Clinical Cure at Test of Cure (TOC) in Participants With HAP/VAP/HCAP or BSI/Sepsis | BSI/Sepsis: Best Available Therapy | 42.9 | 95% Confidence Interval 17.7 to 71.1 | percentage of participants | |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | cUTI: Cefiderocol | 52.9 | 95% Confidence Interval 27.8 to 77.0 | percentage of participants | |
| Percentage of Participants With Microbiologic Eradication at TOC in Participants With cUTI | cUTI: Best Available Therapy | 20.0 | 95% Confidence Interval 0.5 to 71.6 | percentage of participants | |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | HAP/VAP/HCAP: Cefiderocol | 60.0 | 95% Confidence Interval 43.3 to 75.1 | percentage of participants | |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | HAP/VAP/HCAP: Best Available Therapy | 63.2 | 95% Confidence Interval 38.4 to 83.7 | percentage of participants | |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | BSI/Sepsis: Cefiderocol | 69.6 | 95% Confidence Interval 47.1 to 86.8 | percentage of participants | |
| Percentage of Participants With Clinical Cure at End of Treatment (EOT) in Participants With HAP/VAP/HCAP or BSI/Sepsis | BSI/Sepsis: Best Available Therapy | 50.0 | 95% Confidence Interval 23.0 to 77.0 | percentage of participants |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cefiderocol | 101 | |
| Overall Study | STARTED | Best Available Therapy (BAT) | 51 | |
| Overall Study | Received Treatment | Cefiderocol | 101 | |
| Overall Study | Received Treatment | Best Available Therapy (BAT) | 49 | |
| Overall Study | Carbapenem-resistant Microbiological Intent-to-treat | Cefiderocol | 80 | |
| Overall Study | Carbapenem-resistant Microbiological Intent-to-treat | Best Available Therapy (BAT) | 38 | |
| Overall Study | COMPLETED | Cefiderocol | 69 | |
| Overall Study | COMPLETED | Best Available Therapy (BAT) | 38 | |
| Overall Study | NOT COMPLETED | Cefiderocol | 32 | |
| Overall Study | NOT COMPLETED | Best Available Therapy (BAT) | 13 |
Source ClinicalTrials.gov
Adverse events474
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cefiderocol | 8 | 101 | |
| other | Anaemia | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 1 | 49 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Cefiderocol | 1 | 101 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 1 | 49 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Cefiderocol | 0 | 101 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 1 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | Cefiderocol | 2 | 101 | |
| other | Leukopenia | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 1 | 49 | |
| other | Splenic infarction | Blood and lymphatic system disorders | Cefiderocol | 0 | 101 | |
| other | Splenic infarction | Blood and lymphatic system disorders | Best Available Therapy (BAT) | 1 | 49 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cefiderocol | 34 | 101 |
| Total, all-cause mortality | Best Available Therapy (BAT) | 9 | 49 |
| Total, other adverse events | Cefiderocol | 88 | 101 |
| Total, other adverse events | Best Available Therapy (BAT) | 43 | 49 |
| Total, serious adverse events | Cefiderocol | 50 | 101 |
| Total, serious adverse events | Best Available Therapy (BAT) | 23 | 49 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cefiderocol vs Best Available Therapy (BAT): deaths from any cause | Trial comparisons |
| Cefiderocol vs Best Available Therapy (BAT): serious adverse events | Trial comparisons |
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.
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