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Cephalosporin

Cefiderocol for Sepsis

Phase 1
Recruiting
Led By Joseph L Kuti, PharmD
Research Sponsored by Joseph L. Kuti, PharmD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights

Study Summary

This trial is designed to study how well a new antibiotic works in patients on ECMO.

Who is the study for?
This trial is for adults on ECMO support due to critical illness. It's not for pregnant or breastfeeding women, those with recent Cefiderocol use, severe liver injury, very low hemoglobin levels, known severe allergies to β-lactam antibiotics, extreme kidney dysfunction, or anyone facing imminent death within 48 hours.Check my eligibility
What is being tested?
The study investigates how the new antibiotic Cefiderocol behaves in the body when given to critically ill patients on ECMO. The goal is to understand if and how dosing should be adjusted under these special circumstances.See study design
What are the potential side effects?
While specific side effects of Cefiderocol in this trial context are not listed here, common ones may include gastrointestinal disturbances like diarrhea and nausea; potential allergic reactions; and changes in liver enzyme levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cefiderocol Clearance
Secondary outcome measures
Cefiderocol Area Under the Curve (AUC)

Side effects data

From 2019 Phase 3 trial • 300 Patients • NCT03032380
15%
Urinary tract infection
11%
Hypokalaemia
9%
Diarrhoea
8%
Anaemia
6%
Pleural effusion
6%
Aspartate aminotransferase increased
5%
Cardiac arrest
5%
Atrial fibrillation
5%
Constipation
5%
Alanine aminotransferase increased
5%
Hypomagnesaemia
4%
Acute respiratory failure
4%
Pneumonia
4%
Hypoglycaemia
3%
Nausea
3%
Decubitus ulcer
3%
Pyrexia
3%
Clostridium difficile infection
3%
Hyperkalaemia
3%
Septic shock
3%
Multiple organ dysfunction syndrome
3%
Hypocalcaemia
3%
Hydrothorax
3%
Urinary tract infection fungal
3%
Gamma-glutamyltransferase increased
3%
Transaminases increased
3%
Hypoalbuminaemia
3%
Hyponatraemia
3%
Hyperglycaemia
3%
Hypertension
3%
Thrombocytosis
3%
Delirium
3%
Insomnia
2%
Amylase increased
2%
Cardio-respiratory arrest
2%
Hypoproteinaemia
2%
Hepatic enzyme increased
2%
Pneumonia aspiration
2%
Bradycardia
2%
Anxiety
2%
Phlebitis
2%
Sepsis
2%
Pulmonary artery thrombosis
2%
Post procedural haemorrhage
2%
Hyperuricaemia
2%
Iron deficiency anaemia
2%
Headache
1%
Bacteraemia
1%
Vomiting
1%
Autonomic nervous system imbalance
1%
Cerebral ischaemia
1%
Metabolic encephalopathy
1%
Cardiac failure
1%
Cardiovascular insufficiency
1%
Sudden death
1%
Thrombocytopenia
1%
Abdominal wall haematoma
1%
Spinal cord infection
1%
Oedema peripheral
1%
Myocardial infarction
1%
General physical health deterioration
1%
Herpes zoster
1%
Status epilepticus
1%
Gastric haemorrhage
1%
Blood pressure increased
1%
Pulmonary embolism
1%
Coagulopathy
1%
Intestinal infarction
1%
Left ventricular dysfunction
1%
Intestinal ischaemia
1%
Lung infection
1%
Cerebrovascular accident
1%
Intracranial pressure increased
1%
Death
1%
Brain oedema
1%
Subarachnoid haemorrhage
1%
Liver function test increased
1%
Tracheobronchitis
1%
Agitation
1%
Bronchitis
1%
Respiratory failure
1%
Hypoxic-ischaemic encephalopathy
1%
Stroke in evolution
1%
Acute kidney injury
1%
Leg amputation
1%
Stridor
1%
Acute respiratory distress syndrome
1%
Diabetic foot
1%
Metabolic alkalosis
1%
Pulmonary congestion
1%
Hepatocellular injury
1%
Bacterial sepsis
1%
Pneumonia bacterial
1%
Lactic acidosis
1%
Lung cancer metastatic
1%
Pneumothorax spontaneous
1%
Peripheral vascular disorder
1%
Gout
1%
Acute myocardial infarction
1%
Hypotension
1%
Pulmonary hypertension
1%
Pulmonary oedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cefiderocol
Meropenem

Trial Design

1Treatment groups
Experimental Treatment
Group I: CefiderocolExperimental Treatment1 Intervention
Participants will receive four to six doses of Cefiderocol as per current prescribing information based on calculated creatinine clearance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cefiderocol
2020
Completed Phase 3
~1800

Find a Location

Who is running the clinical trial?

Joseph L. Kuti, PharmDLead Sponsor
3 Previous Clinical Trials
47 Total Patients Enrolled
1 Trials studying Sepsis
8 Patients Enrolled for Sepsis
Shionogi Inc.Industry Sponsor
8 Previous Clinical Trials
722 Total Patients Enrolled
Joseph L Kuti, PharmDPrincipal InvestigatorHartford Hospital
4 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Sepsis
8 Patients Enrolled for Sepsis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an opportunity for participants to enroll in this trial?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial is currently calling for participants, having been first published on July 16th 2021 and most recently updated on August 3rd 2022. The study requires 8 volunteers from a single medical centre to partake in the research."

Answered by AI

What is the participant capacity of this investigation?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial has been open for recruitment since July 16th 2021 and was recently amended August 3rd 2022 with a goal of recruiting 8 participants at 1 location."

Answered by AI

What health issues may be addressed through Cefiderocol?

"Infections such as pyelonephritis, nosocomial pneumonia, and bacterial pneumonia can all be managed through the use of Cefiderocol."

Answered by AI

Which other experiments have been performed to evaluate Cefiderocol's efficacy?

"Currently, 4 clinical studies are underway to research Cefiderocol, with none of them reaching the third phase. Hartford hosts most of these trials; however, 84 other medical facilities have taken part in this investigation as well."

Answered by AI

Has the FDA sanctioned Cefiderocol for therapeutic applications?

"The safety of Cefiderocol earned a score of 1 due to the preliminary nature of this Phase 1 trial, meaning there is limited data proving its efficacy and overall safety."

Answered by AI

Is this trial a pioneering endeavor in the medical field?

"Since 2019, Shionogi has been sponsoring research into Cefiderocol. After their initial trial involving 439 subjects in the same year, this drug was granted Phase 2 approval and there are currently four active trials across 10 cities and 21 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cefiderocol PK in Patients on ECMO
Joseph L. Kuti, PharmD 2021. "Cefiderocol PK in Patients on ECMO". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995835.
All > Ecmo > Sepsis
~0 spots leftby Jul 2024
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