Invasive CandidiasisNCT01213823

Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins

An observational study of Invasive Candidiasis and Candidemia, run by Pfizer.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to estimate the relative risk of severe hepatic injury in hospitalized patients with invasive candidiasis and candidemia who received anidulafungin, compared to patients who received caspofungin and/or micafungin. Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Invasive Candidiasis, Candidemia
What is being tested?: Does not apply
How many people: 536 participants
Where: No sites listed yet
Study dates: Sep 2008to May 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Acute-care inpatients aged 18 years or older, with at least one dose of echinocandin antifungal therapy during the hospitalization and a primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia identified in the Premier's PerspectiveTM Comparative Database (PCD) from 01 June 2006 to 30 June 2008.

Who may be able to join

Acute-care inpatients;
Aged 18 years or older;
At least one dose of echinocandin therapy during the hospitalization;
Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia.

Who cannot join

< 18 years of age;
No recorded echinocandin therapy during hospitalization;
Acetaminophen hepatotoxicity;
Pre-existing autoimmune hepatitis;
Autoimmune/metabolic liver disease;
Primary biliary cirrhosis;
Primary sclerosing cholangitis and orthotopic liver transplantation.

About this study

Conditions: Invasive Candidiasis, Candidemia
Being tested: Does not apply
Keywords: invasive candidiasis, candidemia, severe hepatic injury, echinocandins, anidulafungin, caspofungin, micafungin
Medical subject headings: Candidiasis, Invasive, Candidemia

What participants receive

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

Does not applyOther
This is a non-interventional study, therefore the intervention type / name do not apply
Does not applyOther
This is a non-interventional study, therefore the intervention type / name do not apply

Study groups in NCT01213823
Study group	Role	What they receive
Cases		Potential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69) Receives: Other: Does not apply
Controls		Controls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467) Receives: Other: Does not apply

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Any Severe Hepatic Injury Cases and Matched Controls
Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.
Measured: 01 June 2006 to 30 June 2008 (up to 25 Months)

Timeline

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

Sep 2008May 2011

First posted4 Oct 2010 (estimated)
Study startSep 2008
Primary completionMay 2011
Study completionMay 2011

Why it stopped: The study was terminated on May 5, 2011, due to methodological issues. The decision to terminate the study was not based on any safety or efficacy concerns.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 536 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01213823
Sponsor's protocol ID: A8851024
Status last verified: Mar 2016
First submitted: 30 Sep 2010
Last updated: 30 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis

All Invasive Candidiasis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Risk Of Severe Hepatic Injury In Patients With Invasive Candidiasis Treated With Echinocandins
ClinicalTrials.gov ID: NCT01213823
Acronym / sponsor ID: A8851024
Conditions: Invasive Candidiasis, Candidemia
Keywords: invasive candidiasis, candidemia, severe hepatic injury, echinocandins, anidulafungin, caspofungin, micafungin
Study type: Observational
Recruitment status: TerminatedReason stopped: The study was terminated on May 5, 2011, due to methodological issues. The decision to terminate the study was not based on any safety or efficacy concerns.
Enrolment: 536 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 4 Oct 2010 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

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

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Cases	–	Other: Does not applyPotential cases were defined as patients with a diagnosis of severe hepatic injury identified in the acute-care inpatient cohort using ICD-9 codes associated with the case definition of severe liver injury. Case status was validated by a Consultant Gastroenterologist blinded to study drug exposure via medical record review using an apriori algorithm. Only validated cases were included in the analysis (N=69)
Controls	–	Other: Does not applyControls were defined as patients without a diagnosis of severe hepatic injury (i.e. with no ICD-9 codes associated with the case definition of severe liver injury) selected at random from the same acute-care inpatient cohort as cases (N=467)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Acute-care inpatients aged 18 years or older, with at least one dose of echinocandin antifungal therapy during the hospitalization and a primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia identified in the Premier's PerspectiveTM Comparative Database (PCD) from 01 June 2006 to 30 June 2008.

Key inclusion criteria (4 listed)

Acute-care inpatients;
Aged 18 years or older;
At least one dose of echinocandin therapy during the hospitalization;
Primary or secondary ICD-9 discharge diagnosis of invasive candidiasis / candidemia.

Key exclusion criteria (7 listed)

< 18 years of age;
No recorded echinocandin therapy during hospitalization;
Acetaminophen hepatotoxicity;
Pre-existing autoimmune hepatitis;
Autoimmune/metabolic liver disease;

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
Does not applyThis is a non-interventional study, therefore the intervention type / name do not apply	Other	Cases
Does not applyThis is a non-interventional study, therefore the intervention type / name do not apply	Other	Controls

Primary outcome

Number of Any Severe Hepatic Injury Cases and Matched Controls
Time frame: 01 June 2006 to 30 June 2008 (up to 25 Months)
Severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified as: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [ULN] and direct bilirubin >2 times ULN and absence of alkaline phosphatase elevation); 3) ALT levels greater than or equal to (≥) 10 times ULN; 4) ALT levels >3 times ULN and less than (<) 10 times ULN; or 5) classified by clinician. Disease Related Group (DRG) severity of illness coding was reported for severe hepatic injury cases and matched controls.

Results and safety

Results posted to the registry on 4 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cases	69	69
Controls	467	467

Primary outcome: Number of Any Severe Hepatic Injury Cases and Matched Controls

Time frame: 01 June 2006 to 30 June 2008 (up to 25 Months). Number. Unit: Participants

Measure	Cases n = 69	Controls n = 467
DRG Severity Coding 1	0	1
DRG Severity Coding 2	0	10
DRG Severity Coding 3	1	66
DRG Severity Coding 4	68	389

Population analysed: Acute-care participants, with at least 1 dose of echinocandin antifungal therapy and a primary or secondary International Classification of Diseases 9 (ICD-9).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cases	0 of 0	0 of 0	Not reported
Controls	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Study results were invalidated due to lack of temporality, a critical methodological element of the study that was never established for the majority of the cases of severe hepatic injury.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Invasive Candidiasis

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis

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.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Invasive Candidiasis and Candidemia, run by Pfizer.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2016. 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?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Any Severe Hepatic Injury Cases and Matched Controls (time frame: 01 June 2006 to 30 June 2008 (up to 25 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01213823.

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 30 Mar 2016.