Bacterial InfectionsNCT03780140

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

A study testing Cefiderocol in people with Bacterial Infections, run by Shionogi.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial. Read more about this study

Who is it for?: Any age
Conditions the study is for: Bacterial Infections
What is being tested?: Cefiderocol
Type of treatment: Injection or infusion
How many people: Not given
Where: No sites listed yet
Study dates: Start not givento not given
Phase: Expanded access
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Child, Adult, Older adult

Hospitalized patients with serious Gram-negative bacterial infections and who have limited treatment options and are not eligible for a clinical trial.

About this study

Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.

Conditions: Bacterial Infections
Being tested: Cefiderocol
Keywords: S-649266, cefiderocol, Gram-negative
Medical subject headings: Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CefiderocolDrug
Also called S-649266
Cefiderocol for intravenous infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

First posted19 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Expanded access

IDs, dates and publications

ClinicalTrials.gov ID: NCT03780140
Sponsor's protocol ID: S-649266-EA
Status last verified: Feb 2020
First submitted: 17 Dec 2018
Last updated: 28 Feb 2020
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
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RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

All Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections
ClinicalTrials.gov ID: NCT03780140
Acronym / sponsor ID: S-649266-EA
Conditions: Bacterial Infections
Keywords: S-649266, cefiderocol, Gram-negative
Study type: Expanded access
Recruitment status: Approved For Marketing
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
First posted: 19 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Expanded access may be provided for cefiderocol for qualified patients who have limited treatment options and are not eligible for a clinical trial.

Study design

Who may qualify

Sex: All
Age groups: Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CefiderocolAlso: S-649266Cefiderocol for intravenous infusion	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
Shionogi Compassionate UseLink provided by the sponsor.

Related trials for Bacterial Infections

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

Questions about this trial

What is this clinical trial studying?

A study testing Cefiderocol in people with Bacterial Infections, run by Shionogi.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03780140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.