Trial · NCT00672841

β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients

NCT00672841, Not applicable, Completed, Duke University; results first posted 2013-04-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients. Trials, record NCT00672841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00672841

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: β-D-Glucan (BDG) Surveillance With Preemptive Anidulafungin vs. Standard Care for Invasive Candidiasis in Surgical Intensive Care Unit (SICU) Patients
NCT number: NCT00672841
Status: Completed
Phases: Not applicable
Enrollment: 64 participants, actual
Lead sponsor: Duke University
Conditions: Invasive Candidiasis
Interventions: Preemptive Therapy with Anidulafungin, Empiric antifungal therapy based on physician discretion.
First posted: 2008-05-06
Last updated: 2015-02-06
Results first posted: 2013-04-22
Limitations and caveats: This study represents a 1st attempt at preemptive antifungal therapy based on the fungal biomarker 1,3-Beta-D-Glucan in the intensive care unit. Main limitation: the small number of subjects with proven/probable invasive candidiasis.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Participants were followed until ICU discharge, an average of 17 days	Clinical utility was defined as β-D-glucan test performance. Biweekly βDG testing used a threshold of ≥ 60 pg/ml to indicate a positive test for invasive candidiasis. True and false positives, and true and false negatives were confirmed using a composite clinical definition of invasive candidiasis that combines physical symptom/signs and microbiology. Cases of proven/probable invasive fungal infection (IFI) were adjudicated by a single reviewer blinded to group assignment and BDG results.
Primary	Safety and Tolerability of Preemptive Anidulafungin	weekly until ICU discharge	reported as the Number of Adverse Events Possibly Related to Study Drug
Secondary	Validate Gene Expression Signatures Predictive of IC	Study Completion, an average of 17 days
Secondary	Incidence of Proven or Probable Invasive Fungal Infection (IFI)	Participants were followed until ICU discharge, an average of 17 days	Institution specific criteria were used to establish a diagnosis of proven or probable invasive candidiasis. Other IFIs were classified according to the European Organization for Research and Treatment of Cancer/Mycosis Study Group (EORTC/MSG) criteria. However, BDG results were not factored into the EORTC/MSG criteria.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Participants were followed until ICU discharge, an average of 17 days	Two study subjects in the preemptive therapy arm were excluded from the analysis of assay sensitivity and specific due to icteric serum specimens.	participants	NUMBER
SECONDARY	Validate Gene Expression Signatures Predictive of IC	Study Completion, an average of 17 days	Data was not collected for this outcome measure.
SECONDARY	Incidence of Proven or Probable Invasive Fungal Infection (IFI)	Participants were followed until ICU discharge, an average of 17 days	4 subjects in the preemptive therapy were excluded from this analysis. These subjects were treated with empiric antifungal therapy despite repeatedly negative glucan results.	participants	NUMBER
PRIMARY	Safety and Tolerability of Preemptive Anidulafungin	weekly until ICU discharge	Subjects receiving at least 1 dose of anidulafungin were assessed.	events	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Active Surveillance, Preemptive Therapy	True BDG Positives	3	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Standard Care, Empiric Treatment	True BDG Positives	3	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Active Surveillance, Preemptive Therapy	True BDG Negative	19	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Standard Care, Empiric Treatment	True BDG Negative	9	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Active Surveillance, Preemptive Therapy	False BDG Positives	23	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Standard Care, Empiric Treatment	False BDG Positives	5	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Active Surveillance, Preemptive Therapy	False BGD Negatives	0	participants
Clinical Utility of Biweekly β-D-glucan (BDG) Testing in At-risk Intensive Care Unit (ICU) Patients.	Standard Care, Empiric Treatment	False BGD Negatives	0	participants
Incidence of Proven or Probable Invasive Fungal Infection (IFI)	Standard Care, Empiric Treatment		3	participants
Incidence of Proven or Probable Invasive Fungal Infection (IFI)	Active Surveillance, Preemptive Therapy		3	participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Care, Empiric Treatment	17
Overall Study	STARTED	Active Surveillance, Preemptive Therapy	47
Overall Study	COMPLETED	Standard Care, Empiric Treatment	16
Overall Study	COMPLETED	Active Surveillance, Preemptive Therapy	32
Overall Study	NOT COMPLETED	Standard Care, Empiric Treatment	1
Overall Study	NOT COMPLETED	Active Surveillance, Preemptive Therapy	15

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Thrombocytopenia	Blood and lymphatic system disorders	Standard Care, Empiric Treatment	0	5	0
other	Thrombocytopenia	Blood and lymphatic system disorders	Active Surveillance, Preemptive Therapy	2	21	2
other	Abnormal liver function tests	Hepatobiliary disorders	Standard Care, Empiric Treatment	0	5	0
other	Abnormal liver function tests	Hepatobiliary disorders	Active Surveillance, Preemptive Therapy	9	21	9
other	Hypocalcemia	Metabolism and nutrition disorders	Standard Care, Empiric Treatment	0	5	0
other	Hypocalcemia	Metabolism and nutrition disorders	Active Surveillance, Preemptive Therapy	2	21	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Care, Empiric Treatment
Total, all-cause mortality	Active Surveillance, Preemptive Therapy
Total, other adverse events	Standard Care, Empiric Treatment	0	17
Total, other adverse events	Active Surveillance, Preemptive Therapy	10	47
Total, serious adverse events	Standard Care, Empiric Treatment	0	17
Total, serious adverse events	Active Surveillance, Preemptive Therapy	0	47

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22879929	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Active Surveillance, Preemptive Therapy vs Standard Care, Empiric Treatment: Incidence of Proven or Probable Invasive Fungal Infection (IFI)	Trial comparisons
Active Surveillance, Preemptive Therapy vs Standard Care, Empiric Treatment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00672841

GET https://conductscience.org/api/trials/v1/NCT00672841/registered

API reference For AI assistants