Cefiderocol for Pharmacokinetics

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hartford Hospital, Hartford, CT
Pharmacokinetics
Cefiderocol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how CRRT affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving CRRT.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Pharmacokinetics

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 8 to 12 hours

8 to 12 hours
Cefiderocol clearance
Cefiderocol concentration
Cefiderocol maximum concentration

Trial Safety

Safety Progress

1 of 3

Other trials for Pharmacokinetics

Side Effects for

Cefiderocol
15%Urinary tract infection
11%Hypokalaemia
9%Diarrhoea
8%Anaemia
6%Aspartate aminotransferase increased
6%Pleural effusion
5%Constipation
5%Alanine aminotransferase increased
5%Atrial fibrillation
5%Cardiac arrest
5%Hypomagnesaemia
4%Hypoglycaemia
4%Pneumonia
4%Acute respiratory failure
3%Thrombocytosis
3%Nausea
3%Hypoalbuminaemia
3%Septic shock
3%Gamma-glutamyltransferase increased
3%Transaminases increased
3%Hyperkalaemia
3%Hyperglycaemia
3%Hypertension
3%Hydrothorax
3%Insomnia
3%Multiple organ dysfunction syndrome
3%Hyponatraemia
3%Decubitus ulcer
3%Clostridium difficile infection
3%Delirium
3%Urinary tract infection fungal
3%Pyrexia
3%Hypocalcaemia
2%Pulmonary artery thrombosis
2%Iron deficiency anaemia
2%Amylase increased
2%Hepatic enzyme increased
2%Hypoproteinaemia
2%Phlebitis
2%Headache
2%Cardio-respiratory arrest
2%Bradycardia
2%Pneumonia aspiration
2%Post procedural haemorrhage
2%Hyperuricaemia
2%Sepsis
2%Anxiety
1%Hypoxic-ischaemic encephalopathy
1%Bacterial sepsis
1%Death
1%Acute kidney injury
1%Cardiovascular insufficiency
1%Metabolic alkalosis
1%Blood pressure increased
1%Brain oedema
1%Metabolic encephalopathy
1%Bronchitis
1%Status epilepticus
1%Acute myocardial infarction
1%Herpes zoster
1%Intracranial pressure increased
1%Gastric haemorrhage
1%Sudden death
1%Intestinal infarction
1%Bacteraemia
1%Liver function test increased
1%Cerebrovascular accident
1%Stroke in evolution
1%Pulmonary oedema
1%Diabetic foot
1%Thrombocytopenia
1%Oedema peripheral
1%Tracheobronchitis
1%Gout
1%Agitation
1%Pneumonia bacterial
1%Autonomic nervous system imbalance
1%Acute respiratory distress syndrome
1%Lung infection
1%Lung cancer metastatic
1%Pulmonary embolism
1%Abdominal wall haematoma
1%Cardiac failure
1%Hypotension
1%General physical health deterioration
1%Cerebral ischaemia
1%Intestinal ischaemia
1%Peripheral vascular disorder
1%Leg amputation
1%Pulmonary hypertension
1%Pulmonary congestion
1%Hepatocellular injury
1%Myocardial infarction
1%Coagulopathy
1%Pneumothorax spontaneous
1%Left ventricular dysfunction
1%Subarachnoid haemorrhage
1%Vomiting
1%Respiratory failure
1%Lactic acidosis
1%Spinal cord infection
1%Stridor
0%Cardiopulmonary failure
0%Pneumonia necrotising
0%Pseudomonas infection
0%Splenic rupture
0%Encephalopathy
0%Femoral artery embolism
0%Hypovolaemia
0%Disseminated intravascular coagulation
0%Haemorrhagic anaemia
0%Cardiac failure congestive
0%Brain injury
0%Acute abdomen
0%Hepatic function abnormal
0%Systemic candida
0%Septic encephalopathy
0%Lacunar stroke
0%Pneumothorax
0%Shock haemorrhagic
0%Electrolyte imbalance
0%Systemic inflammatory response syndrome
0%Respiratory distress
0%Liver function test abnormal
0%Brain abscess
0%Cardiac failure acute
0%Cardiogenic shock
0%Cardiovascular disorder
0%Meningitis
0%Meningoencephalitis bacterial
0%Cholecystitis acute
0%Chronic obstructive pulmonary disease
0%Hypovolaemic shock
0%Acinetobacter bacteraemia
0%Gastrointestinal haemorrhage
0%Bronchopleural fistula
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03032380) in the Cefiderocol ARM group. Side effects include: Urinary tract infection with 15%, Hypokalaemia with 11%, Diarrhoea with 9%, Anaemia with 8%, Aspartate aminotransferase increased with 6%.

Trial Design

1 Treatment Group

Cefiderocol
1 of 1
Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Cefiderocol · No Placebo Group · Phase 1

Cefiderocol
Drug
Experimental Group · 1 Intervention: Cefiderocol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cefiderocol
2022
Completed Phase 3
~920

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 to 12 hours

Trial Background

Tomefa Asempa, Associate Director, Clinical and Translational Infectious Diseases Research
Principal Investigator
Hartford Hospital
Closest Location: Hartford Hospital · Hartford, CT
2009First Recorded Clinical Trial
1 TrialsResearching Pharmacokinetics
251 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be between the ages of 18 and 55 years.
You are receiving CRRT, CVVH, CVVHD, or CVVHDF.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.