Negative Beta Glucan in ICU Patients

NCT01734525 | Completed Phase 4 Results

• 1 other identifier: Early Therapy
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help. Therefore, the objectives of this study are:

1. 1.To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
2. 2.To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Conditions

Candidemia

Keywords

candidemia; intensive care unit; 1,3 beta-D-glucan

Outcome Measures

Primary Outcomes (1)

• Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin

  The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin

  30 days

Study Arms (1)

Anidulafungin

EXPERIMENTAL

Patients at risk will receive therapy with anidulafungin

Drug: Anidulafungin

Interventions

Anidulafungin DRUG

Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards

Anidulafungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the ICU for \>2 days AND
• Systemic antibiotics on days 1-3 of ICU OR
• Central venous catheter on days 1-3 of ICU
• AND at least 2 of:
• Total parenteral nutrition on days 1-3 of ICU
• Any dialysis on days 1-3 of ICU
• Major surgery in the 7 days before admission in the ICU
• Pancreatitis in the 7 days before admission in the ICU
• Use of corticosteroids for at least 3 days in the 7 days before admission
• Use of other immunosuppressive agents in the 7 days before admission in the ICU
• In addition, the patient must have at least one of the following:
• Fever (axillary temperature \>37.5 oC)
• Hypothermia (axillary temperature \<35 oC)
• Hypotension
• Unexplained acidosis

You may not qualify if:

• Antifungal for \>3 days
• Allergy to an echinocandin

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941913, Brazil

Location

Related Publications (1)

• Nucci M, Nouer SA, Esteves P, Guimaraes T, Breda G, de Miranda BG, Queiroz-Telles F, Colombo AL. Discontinuation of empirical antifungal therapy in ICU patients using 1,3-beta-d-glucan. J Antimicrob Chemother. 2016 Sep;71(9):2628-33. doi: 10.1093/jac/dkw188. Epub 2016 Jun 10.

  PMID: 27287231 DERIVED

MeSH Terms

Conditions

Candidemia

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Marcio Nucci
• Organization: Federal University of Rio de Janeiro

mnucci@hucff.ufrj.br

5521-39382463

Study Officials

• Marcio Nucci, MD

  Universidade Federal do Rio de Janeiro

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 8, 2019
• Results First Posted: July 8, 2019

Record last verified: 2019-04

Locations

BR (1)