NCT02283905

Brief Summary

All patients with pulmonary blastomycosis requiring mechanical ventilation will have their blood concentrations measured for the antifungal drugs, amphotericin-B and voriconazole; as well as an analysis of the susceptibility of their infecting species of blastomyces. This information will then be analyzed relative to their rate of clinical recovery from this serious fungal infection.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

5.3 years

First QC Date

October 31, 2014

Last Update Submit

September 25, 2020

Conditions

Blastomycosis

Keywords

amphotericin-Bcontinuously infusedvoriconazole

Outcome Measures

Primary Outcomes (1)

  • The concentration-time profile of antifungals during treatment relative to the level of susceptibility of the infecting organism

    within the first month of therapy

Secondary Outcomes (3)

  • Clinical recovery - as assessed by time to fever defervescence; and white blood cell (WBC) count resolution

    2 to 3 days

  • Clinical recovery - time to discontinuation of mechanical ventilation

    less than 7 days

  • Clinical recovery - time to respiratory dysfunction resolution

    less than 4 days

Study Arms (1)

Amphotericin-B and Voriconazole

OTHER

Treatment with a 24 hour continuous infusion of amphotericin B deoxycholate at 1.0 mg/kg/day for a total dose of at least 1 g (i.e. \~ 14 days); and then the patient is stepped down to voriconazole 6 mg/kg i.v. q12h for 2 doses, then 4 mg/kg q12h either i.v. or orally as appropriate. The oral dose will be rounded for convenience to either the 200 mg or 400 mg tablet twice daily.

Drug: amphotericin-BDrug: voriconazole

Interventions

amphotericin-BDRUG

continuously infused

Also known as: Fungizone
Amphotericin-B and Voriconazole
voriconazoleDRUG

intravenously or orally administered

Also known as: Vfend
Amphotericin-B and Voriconazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients 18 years of age or older admitted to the intensive care units of St. Boniface General Hospital with a diagnosis of acute pulmonary blastomycosis requiring mechanical ventilation.

You may not qualify if:

  • The patient's data will be excluded if they die within 3 days of hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (4)

  • Chapman SW, Dismukes WE, Proia LA, Bradsher RW, Pappas PG, Threlkeld MG, Kauffman CA; Infectious Diseases Society of America. Clinical practice guidelines for the management of blastomycosis: 2008 update by the Infectious Diseases Society of America. Clin Infect Dis. 2008 Jun 15;46(12):1801-12. doi: 10.1086/588300.

    PMID: 18462107BACKGROUND

  • Chowfin A, Tight R, Mitchell S. Recurrent blastomycosis of the central nervous system: case report and review. Clin Infect Dis. 2000 Jun;30(6):969-71. doi: 10.1086/313828.

    PMID: 10880319BACKGROUND

  • Ariano RE, Mitchelmore BR, Lagace-Wiens PR, Zelenitsky SA. Successful treatment of pulmonary blastomycosis with continuously infused amphotericin B deoxycholate after failure with liposomal amphotericin B. Ann Pharmacother. 2013 Jun;47(6):e26. doi: 10.1345/aph.1R703. Epub 2013 May 14.

    PMID: 23673538BACKGROUND

  • Eriksson U, Seifert B, Schaffner A. Comparison of effects of amphotericin B deoxycholate infused over 4 or 24 hours: randomised controlled trial. BMJ. 2001 Mar 10;322(7286):579-82. doi: 10.1136/bmj.322.7286.579.

    PMID: 11238151BACKGROUND

MeSH Terms

Conditions

Blastomycosis

Interventions

Amphotericin BVoriconazole

Condition Hierarchy (Ancestors)

DermatomycosesMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsSkin Diseases, InfectiousLung DiseasesRespiratory Tract DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert E. Ariano, Pharm.D.

    St. Boniface Hospital

    PRINCIPAL INVESTIGATOR

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
Professor of Pharmacy and Medicine, Critical Care Pharmacist

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 5, 2014

Study Start

June 1, 2015

Primary Completion

September 25, 2020

Study Completion

September 25, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)