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Cephalosporin

Cefiderocol for Pharmacokinetics

Phase 1
Waitlist Available
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 to 12 hours
Awards & highlights

Summary

This trial is designed to assess how a new broad-spectrum antibiotic, Cefiderocol, is affected by continuous renal replacement therapies (CRRT), which are used to provide renal support for critically ill patients with acute kidney injury (AKI).

Who is the study for?
This trial is for adults on continuous renal replacement therapy (CRRT) due to acute kidney injury. It's not for those with severe liver injury, pregnant or breastfeeding women, people allergic to β-lactam antibiotics, those with very low hemoglobin levels, or anyone with a life-threatening illness that could interfere with the study.Check my eligibility
What is being tested?
The study tests how Cefiderocol, a new broad-spectrum antibiotic, behaves in the body of critically ill patients who are receiving CRRT. The goal is to understand if and how dosing should be adjusted in these patients.See study design
What are the potential side effects?
Potential side effects of Cefiderocol may include allergic reactions similar to other β-lactam antibiotics such as skin rashes or more serious hypersensitivity responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 to 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 to 12 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
Cefiderocol concentration
Cefiderocol maximum concentration

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%
Hyperkalaemia
3%
Pyrexia
3%
Clostridium difficile infection
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%
Bronchitis
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%
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 effluent rate
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?

Hartford HospitalLead Sponsor
135 Previous Clinical Trials
19,070 Total Patients Enrolled
Shionogi Inc.Industry Sponsor
8 Previous Clinical Trials
714 Total Patients Enrolled

Media Library

Cefiderocol (Cephalosporin) Clinical Trial Eligibility Overview. Trial Name: NCT05373615 — Phase 1
Pharmacokinetics Research Study Groups: Cefiderocol
Pharmacokinetics Clinical Trial 2023: Cefiderocol Highlights & Side Effects. Trial Name: NCT05373615 — Phase 1
Cefiderocol (Cephalosporin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373615 — Phase 1
~1 spots leftby Oct 2024
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