Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment

NCT00934934

Last updated date
Study Location
Hamilton Health Sciences Centre
Hamilton, Ontario, , Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ventilator Associated Pneumonia, Respiratory Tract Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Adult patients (>18 years old)

2. In the ICU > 48 hours

3. Mechanically ventilated (>48 hours)

4. Grow a Candida spp. on respiratory tract secretion culture (either by Bronchoalveolar Lavage or Endotracheal Aspirate) taken on or between 48 hours before or after the day of their suspicion of respiratory tract infection.

5. Develop a clinical suspicion of respiratory tract infection while ventilated as defined by the following criteria (as defined previously in our VAP trial)5:

- The presence of new, worsening or persistent radiographic features suggestive of pneumonia without another obvious cause AND

- The presence of any two of the following:

- Fever > 38C (core temperature)

- Leukocytosis (>11.0 x109/L) or neutropenia (<3.5 x109/L)

- Purulent endotracheal aspirates or change in character of aspirates

- Isolation of pathogenic bacteria from endotracheal aspirates

- Increasing oxygen requirements

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Patients not expected to be in ICU for more than 72 hours (due to imminent death,
withdrawal of aggressive care or discharge).


2. Patients with Candida spp. in the blood or another sterile body site.


3. Patients colonized at other non-pulmonary body site(s) with Candida.


4. Already being treated with antifungal drugs (because of documented fungal infection,
pre-emptive therapy, or prophylaxis).


5. Allergy to study drugs (Fluconazole or the Echinocandin on formulary at treating
institution).


6. Immunocompromised patients (post-organ transplantation, Acquired Immunodeficiency
Syndrome [AIDS], neutropenia [<1000 absolute neutrophils], corticosteroids [>20
mgs/day of prednisone or equivalent for more than 6 months]). These patients are
excluded since Candida may be more invasive and these patients are much more likely to
require systemic antifungal therapy.


7. Patients with fulminant liver failure or end stage liver disease (Child's Class C).


8. Women who are pregnant or lactating.


9. Enrollment in industry sponsored interventional trial (co-enrollment in other academic
studies would be allowed with the proviso that there was no potential interaction
between the protocols).


10. Prior randomization in this study.

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Ventilator Associated Pneumonia, Respiratory Tract InfectionCandida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment
NCT00934934
  1. Hamilton, Ontario
  2. Kingston, Ontario
  3. Ottawa, Ontario
  4. Montreal, Quebec
  5. Montreal, Quebec
  6. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment
Official Title  ICMJE Candida in the Respiratory Tract Secretions of Critically Ill Patients and The Efficacy of Antifungal Treatment (The CANTREAT Study): A Prospective, Randomized, Double Blind, Placebo Controlled Pilot Study
Brief Summary The purpose of the study is to determine whether the effect of treating Candida spp. isolated in the respiratory tract secretions of patients with a clinical suspicion of ventilator associated pneumonia (VAP) on clinical outcomes will be feasible and supported by biomarker data obtained.
Detailed Description

Candida spp. is commonly retrieved from microbiologic specimens of ICU patients with suspected VAP. It has been associated with increased systemic inflammation and worse clinical outcomes. This association may be due to the propensity for Candida to colonize those who are sicker, who have increased levels of systemic inflammation and worse clinical outcomes. However, an alternate possibility is that Candida is more than a colonizer and is responsible for the clinical and biochemical features observed. The only way to clarify the pathogenic role of Candida from this patient population is to treat the organism and see if patients improve compared to an untreated group. The purpose of this research program is to conduct such a study to determine if Candida in respiratory tract secretions should be routinely treated in critically ill patients. Since a definitive randomized controlled trial designed to demonstrate a reduction in mortality would be large, require the commitment of large amount of resources including both time and money, the investigators propose to first conduct a small pilot feasibility study.

Eligible patients will be randomized to receive antifungal treatment with anidulafungin or placebo. Following enrollment, study treatment (or placebo) will be started as soon as possible. When the Candida or yeast organisms have been speciated and/or a susceptibility profile is known, the study medication will be adjusted based on susceptibility patterns. The investigators propose to treat with antifungal therapy for a total of 14 days.

Patients will be followed daily for their entire stay in ICU or till day 28, whichever comes first. For patients discharged from the ICU to the ward, they will be followed until study treatment is complete (i.e. day 14). Mortality will be determined for the ICU stay, hospital stay and at 90 days. The investigators will record admission and discharge dates to ICU, step down units, and to hospital.

All patients will have 13 mL of blood/day drawn at baseline, day 3, day 8 and at the end of the treatment period on day 14 (or last day of treatment). The samples will be prepared on site and shipped to a central lab for processing. The investigators will use the blood specimens to measure markers of inflammation (C-reactive protein, Procalcitonin, and Interleukin-6 and others as determined by the investigators), markers of candida presence (b-glucan and other potential future markers) and markers of immune dysfunction (to be determined by investigators).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Ventilator Associated Pneumonia
  • Respiratory Tract Infection
Intervention  ICMJE
  • Other: Normal Saline
    Normal Saline
  • Drug: anidulafungin
    TBA
    Other Name: TBA
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Saline will serve as the placebo solution since the active comparator is clear and colourless.
    Intervention: Other: Normal Saline
  • Active Comparator: Antifungal
    Patient will receive a dose daily for a total of 14 days
    Intervention: Drug: anidulafungin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2013)
60
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2009)
80
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adult patients (>18 years old)
  2. In the ICU > 48 hours
  3. Mechanically ventilated (>48 hours)
  4. Grow a Candida spp. on respiratory tract secretion culture (either by Bronchoalveolar Lavage or Endotracheal Aspirate) taken on or between 48 hours before or after the day of their suspicion of respiratory tract infection.
  5. Develop a clinical suspicion of respiratory tract infection while ventilated as defined by the following criteria (as defined previously in our VAP trial)5:

    • The presence of new, worsening or persistent radiographic features suggestive of pneumonia without another obvious cause AND
    • The presence of any two of the following:

      • Fever > 38C (core temperature)
      • Leukocytosis (>11.0 x109/L) or neutropenia (<3.5 x109/L)
      • Purulent endotracheal aspirates or change in character of aspirates
      • Isolation of pathogenic bacteria from endotracheal aspirates
      • Increasing oxygen requirements

Exclusion Criteria:

  1. Patients not expected to be in ICU for more than 72 hours (due to imminent death, withdrawal of aggressive care or discharge).
  2. Patients with Candida spp. in the blood or another sterile body site.
  3. Patients colonized at other non-pulmonary body site(s) with Candida.
  4. Already being treated with antifungal drugs (because of documented fungal infection, pre-emptive therapy, or prophylaxis).
  5. Allergy to study drugs (Fluconazole or the Echinocandin on formulary at treating institution).
  6. Immunocompromised patients (post-organ transplantation, Acquired Immunodeficiency Syndrome [AIDS], neutropenia [<1000 absolute neutrophils], corticosteroids [>20 mgs/day of prednisone or equivalent for more than 6 months]). These patients are excluded since Candida may be more invasive and these patients are much more likely to require systemic antifungal therapy.
  7. Patients with fulminant liver failure or end stage liver disease (Child's Class C).
  8. Women who are pregnant or lactating.
  9. Enrollment in industry sponsored interventional trial (co-enrollment in other academic studies would be allowed with the proviso that there was no potential interaction between the protocols).
  10. Prior randomization in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934934
Other Study ID Numbers  ICMJE CANTREAT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
Study Sponsor  ICMJE Daren K. Heyland
Collaborators  ICMJE
  • The Physicians' Services Incorporated Foundation
  • Queen's University
  • Pfizer
Investigators  ICMJE
Study Chair:Daren Heyland, MDClinical Evaluation Research Unit
PRS Account Clinical Evaluation Research Unit at Kingston General Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP