18 and older, any sex, with Healthcare-associated Pneumonia (HCAP) or Hospital Acquired Pneumonia (HAP). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
All-cause Mortality Rate at Day 14Primary· From first dose of study drug to Day 14
The all-cause mortality (ACM) rate at Day 14 was calculated as the percentage of participants in each treatment group who experienced mortality, regardless of the cause, from the first infusion of study drug up to Day 14.
The Modified Intent-to-Treat Population included all randomized participants who met either of the following criteria:
* Evidence of Gram-negative infection of the lower respiratory tract based on a culture, Gram-stain, or other diagnostic test
* Evidence of a lower respiratory tract infection but culture or other diagnostic tests did not provide a microbiologic diagnosis
Group
Value
95% CI
Cefiderocol
12.4
Meropenem
11.6
Percentage of Participants With Microbiologic Eradication at Test of Cure (TOC)Secondary· Test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21)
Lower respiratory tract specimens (eg, sputum, endotracheal aspiration \[ETA\], endobronchial culture specimens collected by bronchoalveolar lavage \[BAL\], or protected specimen brush \[PSB\], lung biopsy tissue, pleural effusions, etc) were sent to the local microbiology laboratory for isolation and identification of pathogens.
Microbiological outcome by Baseline pathogen at TOC was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline p
Group
Value
95% CI
Cefiderocol
47.6
Meropenem
48.0
Percentage of Participants With Clinical Cure at Test of CureSecondary· Test of cure (7 days after the end of treatment; equivalent to Study Day 14 to 21)
Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
Group
Value
95% CI
Cefiderocol
64.8
Meropenem
66.7
Percentage of Participants With Clinical Cure at Early Assessment (EA)Secondary· Early assessment (Day 3-4 after the start of treatment)
Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
Group
Value
95% CI
Cefiderocol
82.8
Meropenem
83.0
Percentage of Participants With Clinical Cure at End of Treatment (EOT)Secondary· End of treatment (Day 7 to 14)
Clinical outcome was assessed by the investigator as either Clinical Cure, Clinical Failure, or Indeterminate.
Clinical Cure: Resolution or substantial improvement of Baseline signs and symptoms of pneumonia, including a reduction in Sequential Organ Failure Assessment (SOFA) and Clinical Pulmonary Infection Score (CPIS) scores, and improvement or lack of progression of chest radiographic abnormalities such that no additional antibacterial therapy was required for the treatment of the current infection.
Group
Value
95% CI
Cefiderocol
77.2
Meropenem
81.0
Percentage of Participants With Sustained Clinical Cure at Follow-up (FU)Secondary· Follow-up (14 days after the end of treatment; Day 21 to 28)
Clinical outcome was assessed by the investigator at follow-up as either Sustained Clinical Cure, Relapse, or Indeterminate.
Sustained Clinical Cure: 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.
Group
Value
95% CI
Cefiderocol
57.9
Meropenem
57.8
Percentage of Participants With Microbiologic Eradication at Early AssessmentSecondary· Early Assessment, Days 3 to 4
Microbiological outcome by Baseline pathogen at Early Assessment was determined by the sponsor as either Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical ou
Group
Value
95% CI
Cefiderocol
41.9
Meropenem
53.5
Percentage of Participants With Microbiologic Eradication at End of TreatmentSecondary· End of treatment, Day 7 to 14
Microbiological outcome by Baseline pathogen at End of Treatment was determined by the sponsor as either: Eradication, Persistence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy). If it was not possible to obtain an appropriate clinical culture, and the participant had a successful clinical o
Group
Value
95% CI
Cefiderocol
63.7
Meropenem
66.9
Percentage of Participants With Sustained Microbiologic Eradication at Follow-upSecondary· Follow-up (14 days after the end of treatment, Days 21 to 28)
Microbiological outcome by Baseline pathogen at Follow-up was determined by the sponsor as either Sustained Eradication, Persistence, Recurrence, or Indeterminate. Overall per-participant microbiological outcome was determined based on the individual microbiological outcomes for each Baseline pathogen.
Sustained eradication: Absence of all Baseline Gram-negative pathogens from an appropriate clinical specimen (sputum, tracheal aspirate, BAL fluid, protected specimen brush, pleural fluid, or lung biopsy) after TOC. If it was not possible to obtain an appropriate clinical culture and the partic
Group
Value
95% CI
Cefiderocol
43.5
Meropenem
38.6
All-cause Mortality Rate at Day 28Secondary· From first dose of study drug to Day 28
The all-cause mortality (ACM) rate at Day 28 was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first dose of study drug up to Day 28.
Group
Value
95% CI
Cefiderocol
21.0
Meropenem
20.5
All-cause Mortality Rate at the End of StudySecondary· From first dose of study drug through end of study (28 days after end of treatment, up to 42 days)
The all-cause mortality rate during both the treatment and follow-up period (up to the end of study \[EOS\] visit) was calculated as the percentage of participants who experienced mortality, regardless of the cause, from the first infusion of study drug up to EOS. If a participant discontinued from the study before EOS and survival information was not available, then the survival status for this endpoint for the participant was considered unknown.
Group
Value
95% CI
Cefiderocol
26.8
Meropenem
23.3
Total Hospitalization TimeSecondary· From first dose of study drug to test of cure (7 days after end of treatment; equivalent to Study Day 14 to 21) and to follow-up (14 days after the end of treatment; Day 21 to 28)
The length of hospital stay attributable to the study-qualifying infection.
Test of Cure
Group
Value
95% CI
Cefiderocol
11.54
± 7.81
Meropenem
11.47
± 7.32
Follow-up
Group
Value
95% CI
Cefiderocol
13.49
± 10.06
Meropenem
12.98
± 9.59
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through the end of study, up to 42 days..
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07465432 — Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries
· Phase 4
· recruiting
NCT07004049 — Optimising TREATment for Severe Gram-Negative Bacterial Infections
· Phase 4
· recruiting
NCT06547554 — A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants
· Phase 1
· completed
NCT06086626 — A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants
· Phase 2
· completed
NCT05789199 — Use of Cefiderocol in the Management of Gram-Negative Infections
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shionogi
Last refreshed: 13 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03032380.