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Cefiderocol for Cystic Fibrosis

Phase 4
Recruiting
Led By Joseph L Kuti, PharmD
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 0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose
Awards & highlights

Study Summary

This trial will study the effects of a new broad spectrum antibiotic, cefiderocol, on patients with Cystic Fibrosis who are admitted for a pulmonary exacerbation. The study will take place over 2 days and will assess the safety and tolerability of the antibiotic.

Eligible Conditions
  • Cystic Fibrosis
  • Bacterial Pneumonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance
Volume of Distribution
Secondary outcome measures
Probability of Target Attainment at 4 mcg/mL

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 intravenous cefiderocol at a dosing regimen consistent with the current prescribing information and according estimated renal function. Each dose will be infused over 3 hours.
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
133 Previous Clinical Trials
18,920 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
Shionogi Inc.Industry Sponsor
8 Previous Clinical Trials
718 Total Patients Enrolled
Keystone Bioanalytical, Inc.UNKNOWN
2 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

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

Are there any opportunities to participate in this experiment presently?

"Affirmative. According to clinicaltrials.gov, this medical trial was initially posted on June 1st 2022 and is currently searching for 12 volunteers at 5 separate locations. The date of the last update was October 6th 2022."

Answered by AI

What kind of safety record does Cefiderocol possess?

"Years of research have yielded a wealth of evidence regarding the safety profile of cefiderocol, resulting in it receiving a score 3 on our risk assessment scale."

Answered by AI

In which geographical locations is this study currently in operation?

"Patients are being accepted to this medical trial at UT Southwestern Clements University Hospital in Dallas, Texas, IU Health University Hospital in Pittsburgh, Indiana, Hartford Hospital in Indianapolis, Connecticut and five additional sites."

Answered by AI

What is the aggregate participant count of this clinical trial?

"This clinical trial necessitates 12 participants who meet the eligibility requirements. They may enter this study in either UT Southwestern Clements University Hospital located in Dallas, Texas or IU Health University Hospital situated in Pittsburgh, Indiana."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
Joseph L. Kuti, PharmD 2022. "Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05314764.
All > Cystic Fibrosis
~4 spots leftby Apr 2025
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