Trial · NCT03862040
Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
NCT03862040, Phase 1, Terminated, Shionogi; results first posted 2020-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia. Trials, record NCT03862040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03862040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
- NCT number
- NCT03862040
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Shionogi
- Conditions
- Bacterial Pneumonia
- Interventions
- Cefiderocol, Standard of Care Antibiotic
- First posted
- 2019-03-05
- Last updated
- 2020-11-05
- Results first posted
- 2020-11-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of Cefiderocol in Epithelial Lining Fluid | At the third dosing (or sixth dosing for participants with severe renal impairment; 16 or 40 hours after first dose, respectively), at 3 hours after the start of the infusion or 2 hours after the end of infusion. | Samples for determination of cefiderocol concentrations in the epithelial lining fluid (ELF) were collected by bronchoalveolar lavage (BAL) procedure on the inflamed section of the lung (ie, a lobe where pneumonia was expected to be present based on chest radiologic imaging) after multiple doses of cefiderocol sufficient to approximate steady state concentrations in blood. The ELF sample for the determination of cefiderocol concentrations was collected at 3 hours after the start of administration of cefiderocol for the first 4 enrolled participants and at 2 hours after the end of infusion for the following 3 participants. Cefiderocol concentrations were determined using liquid chromatography/tandem mass spectrometry (LC/MS/MS), with a lower limit of quantification of cefiderocol in ELF of 0.005 μg/mL. Cefiderocol concentrations in ELF were calculated using cefiderocol concentrations in BAL, adjusted by the ratio of urea concentrations in blood and BAL. |
| Primary | Ratio of the Concentration of Cefiderocol in Epithelial Lining Fluid Relative to Plasma | At the third dosing (or sixth dosing for participants with severe renal impairment; 16 or 40 hours after start of the first dose, respectively), at 3 hours after the start of the infusion or 2 hours after the end of infusion. | The concentration of cefiderocol in ELF to plasma ratio (RC,E/P) represents the penetration of cefiderocol into infected lung tissue. ELF and plasma cefiderocol concentrations were determined using liquid chromatography/tandem mass spectrometry (LC/MS/MS). The lower limit of quantification of cefiderocol in plasma and ELF was 0.1 μg/mL and 0.005 μg/mL, respectively. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Concentration of Cefiderocol in Epithelial Lining Fluid | At the third dosing (or sixth dosing for participants with severe renal impairment; 16 or 40 hours after first dose, respectively), at 3 hours after the start of the infusion or 2 hours after the end of infusion. | All participants who received at least 1 dose of cefiderocol and who had at least 1 evaluable concentration of cefiderocol in bronchoalveolar lavage fluid. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Ratio of the Concentration of Cefiderocol in Epithelial Lining Fluid Relative to Plasma | At the third dosing (or sixth dosing for participants with severe renal impairment; 16 or 40 hours after start of the first dose, respectively), at 3 hours after the start of the infusion or 2 hours after the end of infusion. | All participants who received at least 1 dose of cefiderocol and who had at least 1 evaluable concentration of cefiderocol in bronchoalveolar lavage fluid. Cefiderocol concentration was measured 3 hours after the start of the infusion in the first 4 enrolled participants and 2 hours after the end of infusion in the following 3 participants. | ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Concentration of Cefiderocol in Epithelial Lining Fluid | Cefiderocol | 3 hours after start of infusion | 7.63 | Full Range 3.10 to 20.7 | μg/mL |
| Concentration of Cefiderocol in Epithelial Lining Fluid | Cefiderocol | 2 hours after end of infusion | 10.4 | Full Range 7.19 to 15.9 | μg/mL |
| Ratio of the Concentration of Cefiderocol in Epithelial Lining Fluid Relative to Plasma | Cefiderocol | 3 hours after start of infusion | 0.0893 | Full Range 0.0379 to 0.178 | ratio |
| Ratio of the Concentration of Cefiderocol in Epithelial Lining Fluid Relative to Plasma | Cefiderocol | 2 hours after end of infusion | 0.231 | Full Range 0.187 to 0.347 | ratio |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cefiderocol | 7 | |
| Overall Study | COMPLETED | Cefiderocol | 7 | |
| Overall Study | NOT COMPLETED | Cefiderocol | 0 |
Source ClinicalTrials.gov
Adverse events17
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 | Wheezing | Respiratory, thoracic and mediastinal disorders | Cefiderocol | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Cefiderocol | 2 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cefiderocol | 1 | 7 | |
| other | Atrial fibrillation | Cardiac disorders | Cefiderocol | 1 | 7 | |
| other | Contusion | Injury, poisoning and procedural complications | Cefiderocol | 1 | 7 | |
| other | Tracheostomy malfunction | Injury, poisoning and procedural complications | Cefiderocol | 1 | 7 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Cefiderocol | 1 | 7 | |
| other | Hypernatraemia | Metabolism and nutrition disorders | Cefiderocol | 1 | 7 | |
| other | Hypophosphataemia | Metabolism and nutrition disorders | Cefiderocol | 2 | 7 | |
| other | Hyperchloraemia | Metabolism and nutrition disorders | Cefiderocol | 1 | 7 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cefiderocol | 0 | 7 |
| Total, other adverse events | Cefiderocol | 7 | 7 |
| Total, serious adverse events | Cefiderocol | 0 | 7 |
Source ClinicalTrials.gov
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/NCT03862040
GET https://conductscience.org/api/trials/v1/NCT03862040/registered