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Cephalosporin

Cefiderocol for Pharmacokinetics

Phase 1
Recruiting
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
No Placebo-Only Group

Study 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).

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%
Aspartate aminotransferase increased
6%
Pleural effusion
5%
Atrial fibrillation
5%
Cardiac arrest
5%
Alanine aminotransferase increased
5%
Hypomagnesaemia
5%
Constipation
4%
Acute respiratory failure
4%
Pneumonia
4%
Hypoglycaemia
3%
Multiple organ dysfunction syndrome
3%
Septic shock
3%
Urinary tract infection fungal
3%
Gamma-glutamyltransferase increased
3%
Transaminases increased
3%
Hypoalbuminaemia
3%
Hyponatraemia
3%
Hyperglycaemia
3%
Hypocalcaemia
3%
Hyperkalaemia
3%
Decubitus ulcer
3%
Hypertension
3%
Thrombocytosis
3%
Clostridium difficile infection
3%
Nausea
3%
Pyrexia
3%
Delirium
3%
Insomnia
3%
Hydrothorax
2%
Bradycardia
2%
Cardio-respiratory arrest
2%
Sepsis
2%
Pneumonia aspiration
2%
Pulmonary artery thrombosis
2%
Post procedural haemorrhage
2%
Hepatic enzyme increased
2%
Amylase increased
2%
Hypoproteinaemia
2%
Hyperuricaemia
2%
Phlebitis
2%
Iron deficiency anaemia
2%
Headache
2%
Anxiety
1%
Intestinal infarction
1%
Intestinal ischaemia
1%
Liver function test increased
1%
Bronchitis
1%
Acute kidney injury
1%
Gastric haemorrhage
1%
Metabolic encephalopathy
1%
Status epilepticus
1%
Stroke in evolution
1%
Blood pressure increased
1%
Intracranial pressure increased
1%
Tracheobronchitis
1%
Death
1%
Acute respiratory distress syndrome
1%
Thrombocytopenia
1%
Sudden death
1%
Cardiac failure
1%
Cardiovascular insufficiency
1%
Hepatocellular injury
1%
Bacterial sepsis
1%
Herpes zoster
1%
Lung infection
1%
Pneumonia bacterial
1%
Spinal cord infection
1%
Subarachnoid haemorrhage
1%
Lactic acidosis
1%
Lung cancer metastatic
1%
Pneumothorax spontaneous
1%
Pulmonary embolism
1%
Respiratory failure
1%
Peripheral vascular disorder
1%
Gout
1%
Acute myocardial infarction
1%
Hypotension
1%
Left ventricular dysfunction
1%
Myocardial infarction
1%
General physical health deterioration
1%
Pulmonary hypertension
1%
Pulmonary oedema
1%
Stridor
1%
Diabetic foot
1%
Leg amputation
1%
Metabolic alkalosis
1%
Autonomic nervous system imbalance
1%
Coagulopathy
1%
Abdominal wall haematoma
1%
Bacteraemia
1%
Brain oedema
1%
Cerebral ischaemia
1%
Cerebrovascular accident
1%
Hypoxic-ischaemic encephalopathy
1%
Vomiting
1%
Oedema peripheral
1%
Agitation
1%
Pulmonary congestion
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 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
132 Previous Clinical Trials
18,930 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

Frequently Asked Questions

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

What is the current enrollment capacity for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this scientific inquiry is currently on the search for volunteers as it was initially posted on July 25th 2022 and last modified August 1st 2022. 16 participants are needed from one location."

Answered by AI

To what extent has Cefiderocol been found to be hazardous for individuals?

"Cefiderocol has limited clinical evidence supporting its efficacy and safety, so it garnered a score of 1."

Answered by AI

Does this experiment allow for the participation of individuals aged 55 and over?

"This medical study outlines that the age range of participants is 18-120, with 3 separate studies for those younger and 29 trials specifically targeting older adults."

Answered by AI

Which demographics meet the eligibility requirements for this clinical experiment?

"This medical investigation is recruiting up to 16 participants aged between 18 and 120 with pharmacokinetics. Additional criteria for these patients include being at least eighteen years old, as well receiving some form of continuous renal replacement therapy including CVVH, CVVHD, or CVVHDF support."

Answered by AI

Is the recruitment process still open for this trial?

"That is correct. According to the clinicaltrials.gov website, this medical trial is actively seeking 16 participants from a single location and was initially posted on July 25th 2022 with its most recent update taking place August 1st of that same year."

Answered by AI
~6 spots leftby Feb 2025