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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
Must not have
Females who are pregnant or breast-feeding
Severe renal dysfunction defined as a CrCL < 15 mL/min (as calculated by the Cockcroft Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how a new antibiotic, Cefiderocol, behaves in critically ill patients who are on ECMO life-support. ECMO helps patients breathe by taking over heart and lung functions, which can change how drugs work in their bodies. The goal is to understand these changes to ensure proper dosing of Cefiderocol. Cefiderocol is a new antibiotic designed to treat multi-drug resistant bacteria, including Acinetobacter baumannii.

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.
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.
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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant or breastfeeding.
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I have severe kidney problems or am on dialysis.
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I do not have a condition that could lead to death within 48 hours.
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I am being treated with Cefiderocol for an infection or expected to be treated with it soon.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1890

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
9 Previous Clinical Trials
762 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
~2 spots leftby Dec 2025
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