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

Candidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604705
• Other study ID #: APX001-201
• Secondary ID: C4791009
• Status: Completed
• Phase: Phase 2
• Start date: October 3, 2018
• Est. completion date: July 2, 2020

Study information

• Verified date: May 2024
• Source: Basilea Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidemia

Intervention

Drug:
• APX001
APX001

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Institut Jules Bordet,Service De Microbiologie	Brussels
Belgium	Universite Libre de Bruxelles (ULB) - Hopital Erasme	Brussels
Belgium	CHU de Charleroi - Hopital Civil Marie Curie	Lodelinsart
Belgium	Mont-Godinne University Hospital	Yvoir
Belgium	University Hospital Mont-Godinne	Yvoir
Germany	Klinik I fur Innere Medizin- Uniklinik Koln	Cologne
Germany	University Hospital Heidelberg	Heidelberg
Germany	Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. Medizinische Klinik Haematologie/Onkologie	Mainz
Israel	Infectious Diseases Unit, Rambam Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Infectious Diseases Unit	Tel Aviv
Israel	Sourasky Medical Center	Tel Aviv
Israel	Infectious Diseases Unit,Sheba Medical Center	Tel Hashomer
Israel	Sheba Medical Center	Tel HaShomer
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital VLL D Hebron	Barcelona
Spain	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona
United States	Augusta University (Georgia Regents University)	Augusta	Georgia
United States	University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	University of Alabama at Birmingham School of Medicine	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	University of California, Davis	Davis	California
United States	Duke University Hospital Medical Center	Durham	North Carolina
United States	University of Texas- Health Science Center and Medical School at Houston	Houston	Texas
United States	University of California-Davis Medical Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Basilea Pharmaceutica

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One to forty-two days
Secondary	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.	One to forty-nine days
Secondary	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)		End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT)
Secondary	Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)		2 and 4 weeks after end of treatment (EOT)
Secondary	Overall Survival at Study Day 30		Day 30
Secondary	Number of Patients With Treatment Emergent Adverse Events (TEAEs)		One to forty-nine days