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An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

Primary Purpose

Candidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APX001
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Provision of written consent
  • Adults ages 18 and above male or female
  • New diagnosis of candidemia
  • Able to have pre-existing intravascular catheters removed and replaced (as necessary)

Key Exclusion Criteria:

  • neutropenia
  • deep-seated Candida-related infections
  • hepatosplenic candidiasis
  • received more than 2 days of prior systemic antifungal treatment for current candidemia episode
  • severe hepatic impairment

Sites / Locations

  • University of Alabama at Birmingham School of Medicine
  • University of Alabama at Birmingham (UAB)
  • University of California, Davis
  • University of California-Davis Medical Center
  • Augusta University (Georgia Regents University)
  • University of Chicago
  • Washington University
  • Duke University Hospital Medical Center
  • University of Texas- Health Science Center and Medical School at Houston
  • Institut Jules Bordet,Service De Microbiologie
  • Hopital Erasme
  • Institut Jules Bordet
  • Universite Libre de Bruxelles (ULB) - Hopital Erasme
  • CHU de Charleroi - Hopital Civil Marie Curie
  • Mont-Godinne University Hospital
  • University Hospital Mont-Godinne
  • Klinik I fur Innere Medizin- Uniklinik Koln
  • University Hospital Heidelberg
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie
  • Infectious Diseases Unit, Rambam Medical Center
  • Rambam Medical Center
  • Infectious Diseases Unit
  • Sourasky Medical Center
  • Infectious Diseases Unit,Sheba Medical Center
  • Sheba Medical Center
  • Hospital Universitario Mutua de Terrassa
  • Hospital General Universitario de Alicante
  • Hospital Universitari Vall d'Hebron
  • Hospital VLL D Hebron

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APX001 Treatment

Arm Description

Outcomes

Primary Outcome Measures

Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)
Treatment Success is defined as meeting all of the following criteria: Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment

Secondary Outcome Measures

Time to First Negative Blood Culture
Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date.
Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)
Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)
Overall Survival at Study Day 30
Number of Patients With Treatment Emergent Adverse Events (TEAEs)

Full Information

First Posted
July 19, 2018
Last Updated
March 31, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03604705
Brief Title
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Official Title
An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
July 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older. Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APX001 Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
APX001
Intervention Description
APX001
Primary Outcome Measure Information:
Title
Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)
Description
Treatment Success is defined as meeting all of the following criteria: Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment
Time Frame
One to forty-two days
Secondary Outcome Measure Information:
Title
Time to First Negative Blood Culture
Description
Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date.
Time Frame
One to forty-nine days
Title
Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)
Time Frame
End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT)
Title
Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)
Time Frame
2 and 4 weeks after end of treatment (EOT)
Title
Overall Survival at Study Day 30
Time Frame
Day 30
Title
Number of Patients With Treatment Emergent Adverse Events (TEAEs)
Time Frame
One to forty-nine days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Provision of written consent Adults ages 18 and above male or female New diagnosis of candidemia Able to have pre-existing intravascular catheters removed and replaced (as necessary) Key Exclusion Criteria: neutropenia deep-seated Candida-related infections hepatosplenic candidiasis received more than 2 days of prior systemic antifungal treatment for current candidemia episode severe hepatic impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham (UAB)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
University of California-Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Augusta University (Georgia Regents University)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Duke University Hospital Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Texas- Health Science Center and Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Institut Jules Bordet,Service De Microbiologie
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
Country
Belgium
Facility Name
Universite Libre de Bruxelles (ULB) - Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
CHU de Charleroi - Hopital Civil Marie Curie
City
Lodelinsart
Country
Belgium
Facility Name
Mont-Godinne University Hospital
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
University Hospital Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
Klinik I fur Innere Medizin- Uniklinik Koln
City
Cologne
Country
Germany
Facility Name
University Hospital Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie
City
Mainz
Country
Germany
Facility Name
Infectious Diseases Unit, Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Infectious Diseases Unit
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Infectious Diseases Unit,Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sheba Medical Center
City
Tel HaShomer
Country
Israel
Facility Name
Hospital Universitario Mutua de Terrassa
City
Terrassa
State/Province
Barcelona
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital VLL D Hebron
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=APX001-201
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

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