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Cefiderocol Pharmacokinetics in Adult Patients With 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
- Pneumonia
- Bacterial Pneumonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 1.5, 3, 3.25, 4, 5, 6, and 8 hours after the final dose
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 • NCT0303238015%
Urinary tract infection
11%
Hypokalaemia
9%
Diarrhoea
8%
Anaemia
6%
Aspartate aminotransferase increased
6%
Pleural effusion
5%
Constipation
5%
Atrial fibrillation
5%
Hypomagnesaemia
5%
Cardiac arrest
5%
Alanine aminotransferase increased
4%
Hypoglycaemia
4%
Pneumonia
4%
Acute respiratory failure
3%
Septic shock
3%
Gamma-glutamyltransferase increased
3%
Multiple organ dysfunction syndrome
3%
Hypoalbuminaemia
3%
Pyrexia
3%
Thrombocytosis
3%
Hyperkalaemia
3%
Transaminases increased
3%
Hyponatraemia
3%
Hydrothorax
3%
Nausea
3%
Clostridium difficile infection
3%
Urinary tract infection fungal
3%
Decubitus ulcer
3%
Hypocalcaemia
3%
Hypertension
3%
Hyperglycaemia
3%
Delirium
3%
Insomnia
2%
Amylase increased
2%
Phlebitis
2%
Post procedural haemorrhage
2%
Bradycardia
2%
Hyperuricaemia
2%
Hypoproteinaemia
2%
Iron deficiency anaemia
2%
Headache
2%
Sepsis
2%
Pulmonary artery thrombosis
2%
Hepatic enzyme increased
2%
Pneumonia aspiration
2%
Cardio-respiratory arrest
2%
Anxiety
1%
Metabolic alkalosis
1%
Stroke in evolution
1%
Thrombocytopenia
1%
Cerebral ischaemia
1%
Abdominal wall haematoma
1%
Acute kidney injury
1%
Subarachnoid haemorrhage
1%
Pneumothorax spontaneous
1%
Acute respiratory distress syndrome
1%
Pulmonary oedema
1%
Sudden death
1%
Herpes zoster
1%
Lung infection
1%
Stridor
1%
Vomiting
1%
Gout
1%
Pulmonary congestion
1%
Autonomic nervous system imbalance
1%
Brain oedema
1%
Cerebrovascular accident
1%
Myocardial infarction
1%
Blood pressure increased
1%
Peripheral vascular disorder
1%
Oedema peripheral
1%
Cardiac failure
1%
General physical health deterioration
1%
Pulmonary hypertension
1%
Leg amputation
1%
Intestinal ischaemia
1%
Hypoxic-ischaemic encephalopathy
1%
Gastric haemorrhage
1%
Lung cancer metastatic
1%
Pneumonia bacterial
1%
Acute myocardial infarction
1%
Lactic acidosis
1%
Hepatocellular injury
1%
Diabetic foot
1%
Intracranial pressure increased
1%
Intestinal infarction
1%
Pulmonary embolism
1%
Tracheobronchitis
1%
Bronchitis
1%
Hypotension
1%
Status epilepticus
1%
Left ventricular dysfunction
1%
Bacterial sepsis
1%
Spinal cord infection
1%
Liver function test increased
1%
Respiratory failure
1%
Bacteraemia
1%
Metabolic encephalopathy
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
Indiana University Health Methodist HospitalOTHER
3 Previous Clinical Trials
5,275 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
University of Pittsburgh Medical CenterOTHER
73 Previous Clinical Trials
76,857 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
16 Patients Enrolled for Cystic Fibrosis
University of TexasOTHER
189 Previous Clinical Trials
143,027 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
687 Patients Enrolled for Cystic Fibrosis
Joseph L Kuti, PharmDPrincipal InvestigatorHartford Hospital
4 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
39 Patients Enrolled for Cystic Fibrosis