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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Multiple-dose phase: Participant has a suspected or confirmed cUTI, HABP, or VABP that requires hospitalization for treatment with IV antibiotics
Single-dose phase: Participant has a suspected or confirmed infection type (including but not limited to cUTI, complicated intra-abdominal infections [cIAI], pneumonia, HABP/VABP, and sepsis or bloodstream infections [BSI]) that requires hospitalization for treatment with IV antibiotics.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during one of the dosing intervals from day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of cefiderocol in children with various bacterial infections.
Who is the study for?
This trial is for hospitalized children aged 3 months to less than 18 years with certain bacterial infections, including pneumonia and urinary tract infections. They must need IV antibiotics and not have severe kidney issues or allergies to beta-lactam antibiotics. Sexually active participants must agree to use contraception.Check my eligibility
What is being tested?
The study tests the safety, tolerability, and how the body processes Cefiderocol—a drug for treating Gram-negative bacterial infections—compared with standard care in sick kids who are given either a single dose or multiple doses depending on their age and infection type.See study design
What are the potential side effects?
Possible side effects of Cefiderocol may include allergic reactions similar to other antibiotics like rash or itching, digestive problems such as nausea or diarrhea, changes in blood test results indicating liver or kidney function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am hospitalized for a serious urinary or lung infection needing IV antibiotics.
Select...
I am hospitalized for an infection needing IV antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during one of the dosing intervals from day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during one of the dosing intervals from day 5-14, 1 (cohort 2 1 and 2 only), 3, 3.5 (cohorts 1 and 2 only), 5, and 8 hours after the start of infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Terminal Elimination Half-life of Cefiderocol in the Multiple Dose Phase
Apparent Terminal Elimination Half-life of Cefiderocol in the Single Dose Phase
Area Under the Plasma Concentration Time Curve Extrapolated from Time 0 to Infinity (AUCinf) of Cefiderocol in the Single Dose Phase
+5 moreSide effects data
From 2019 Phase 3 trial • 300 Patients • NCT0303238015%
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
3Treatment groups
Experimental Treatment
Active Control
Group I: Single Dose Phase: CefiderocolExperimental Treatment2 Interventions
Participants will receive a single dose of cefiderocol administered intravenously (IV) on Day 1, in addition to standard of care. Participants weighing less than 34 kilograms (kg) will receive 60 milligrams (mg)/kg cefiderocol and participants ≥34 kg will receive 2000 mg.
Group II: Multiple Dose Phase: CefiderocolExperimental Treatment2 Interventions
Participants will receive cefiderocol administered via IV every 8 hours for an expected 5 to 14 days in addition to standard of care. Participants weighing less than 34 kg will receive 60 mg/kg cefiderocol and participants ≥ 34 kg will receive 2000 mg. Dosage may be adjusted based on renal function.
Group III: Multiple Dose Phase: Standard of Care AloneActive Control1 Intervention
Participants will receive standard of care treatment according to local standards.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Cefiderocol
2020
Completed Phase 3
~1800
Find a Location
Who is running the clinical trial?
ShionogiLead Sponsor
116 Previous Clinical Trials
41,401 Total Patients Enrolled
1 Trials studying Bacterial Pneumonia
7 Patients Enrolled for Bacterial Pneumonia
Shionogi Clinical Trials Administrator Clinical Support Help LineStudy DirectorShionogi
41 Previous Clinical Trials
13,852 Total Patients Enrolled
1 Trials studying Bacterial Pneumonia
7 Patients Enrolled for Bacterial Pneumonia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another illness that is very serious and may significantly shorten your life.I have a very weak immune system or very low levels of neutrophils.I have severe kidney disease and am on dialysis or receiving special filtration treatments.I am currently breastfeeding.I have experienced shock recently or am currently in shock.I agree to use effective birth control during and up to 28 days after the study.I have given or will give my written agreement to participate, if I am of the age required by law.I have or might have an infection in my brain, spinal cord, or bones needing long-term antibiotics.I am between 3 months and 18 years old for multiple-dose, or up to 12 years for single-dose.I am pregnant, as confirmed by a test.My kidney function is low, as shown by my eGFR test results.My kidney function is very low, as shown by my eGFR test results.My infection is caused by a confirmed Gram-positive pathogen.You have had a bad reaction to a certain type of antibiotics called β-lactams, but a mild rash is okay.I have cystic fibrosis.My organs are failing.I am on medication to raise my blood pressure.I am hospitalized for a serious urinary or lung infection needing IV antibiotics.I am hospitalized for an infection needing IV antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Single Dose Phase: Cefiderocol
- Group 2: Multiple Dose Phase: Standard of Care Alone
- Group 3: Multiple Dose Phase: Cefiderocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the participation of elderly individuals encouraged in this experiment?
"The parameters for this clinical trial necessitate that the patients enrolled must be within 3 Months and 17 years of age. 237 trials are available to pediatric populations while 782 studies have been specifically designed with geriatric participants in mind."
Answered by AI
Has Cefiderocol been granted regulatory authorization by the FDA?
"Due to the absence of efficacy data, but limited safety evidence from a Phase 2 trial, our team assigned Cefiderocol a score of 2."
Answered by AI
Is this trial accepting new participants at the present time?
"The evidence available on clinicaltrials.gov suggests that enrollment for this medical trial is currently open. The study was first posted in February 19th 2020 and updated most recently in September 23rd 2022."
Answered by AI
Who meets the criteria for involvement in this medical experiment?
"This clinical trial has capacity for 85 participants battling pneumonia and bacterial infections aged between 3 months to 17 years. Eligibility requirements encompasses written consent from the patient's parent or legal representative, as well as various age restrictions depending on the phase of treatment. Further, sexually active female candidates must use reliable forms of contraception during screening up until 28 days after their final dose."
Answered by AI
Has Cefiderocol previously been subject to any other investigations?
"Presently, there are 4 ongoing Cefiderocol studies with 0 trials in the late-stage phase. Most of these investigations take place in Hartford, Connecticut; however, 84 other facilities across the world are also conducting research on this drug."
Answered by AI
Has this research endeavor been previously attempted elsewhere?
"Research on cefiderocol has been ongoing since 2019, spearheaded by a Phase 1 study organised by Shionogi. After this initial trial of 439 patients was concluded in the same year, Cefiderocol received its approval for clinical trials during Phase 2 and is now being examined through four separate studies conducted over 10 cities spanning 21 countries."
Answered by AI
What clinical applications has Cefiderocol been used for?
"Cefiderocol is generally prescribed for pyelonephritis, with the added capability to combat nosocomial pneumonia, bacterial pneumonia, and a variety of susceptible gram-negative microorganisms."
Answered by AI
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