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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial is testing cefiderocol, a new IV antibiotic, in adults with Cystic Fibrosis who have lung infections. These patients often have infections that are hard to treat with regular antibiotics. Cefiderocol works by pretending to be iron, which bacteria need, and then kills the bacteria from the inside. This new antibiotic is designed to treat infections that are resistant to multiple drugs.

Eligible Conditions
  • Cystic Fibrosis
  • Bacterial Pneumonia
  • 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

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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 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
~1890

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
138 Previous Clinical Trials
19,385 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
Shionogi Inc.Industry Sponsor
9 Previous Clinical Trials
758 Total Patients Enrolled
Keystone Bioanalytical, Inc.UNKNOWN
2 Previous Clinical Trials
50 Total Patients Enrolled
~4 spots leftby Nov 2025
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