Clinical trial NCT00537329: Anidulafungin In Treatment Of Candidemia In Asian Subjects
Official title: A Phase IIIB Pilot Study Of Efficacy And Safety Of Anidulafungin In The Treatment Of Candidemia In Asian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.
* Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.
* Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.

Exclusion Criteria:

* Prior exposure to systemic antifungals for more than 48 hours.
* Subjects who had, at any time, previously received anidulafungin.
* Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples.
* Life expectancy \< 72 hours.

Primary outcomes:
measure: Number of Subjects With Global Response of Success at End of Treatment
timeFrame: End of treatment (EOT) = Day 5 up to Day 42
Secondary outcomes:
measure: Number of Subjects With Global Response of Success at Endpoints
timeFrame: End of intravenous treatment (EOIT), end of Week 2 after EOT (2 Wks post EOT), end of Week 6 after EOT (6 Wks post EOT), at end of 12 weeks after baseline (12 Wks post baseline)
measure: Number of Subjects With Clinical Response of Success at Endpoints
timeFrame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline
measure: Number of Subjects With Microbiological Response of Success at Endpoints
timeFrame: EOIT, EOT (Day 5 up to Day 42), 2 Wks post EOT, 6 Wks post EOT, 12 Wks post baseline
measure: Time to Death From Any Cause
timeFrame: Baseline through end of 12 weeks after baseline
measure: Time to Death Due to Candidemia
timeFrame: Baseline through end of 12 weeks after baseline
measure: Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
timeFrame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)
measure: Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment
timeFrame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)
measure: Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment
timeFrame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)
measure: Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT
timeFrame: Baseline, Day 3, Day 5, Day 7, EOT (Day 5 up to Day 42)
measure: Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups
timeFrame: EOT (Day 5 up to Day 42)
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Noida
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Legaspi Village, Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Pan-Chiao
country: Taiwan
facility: Pfizer Investigational Site
state: Taipei
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Pathumwan
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Amphoe Mueang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
city: Amphoe Mueang
country: Thailand
facility: Pfizer Investigational Site
state: Khon Kaen
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
citation: Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
citation: Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
citation: Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
citation: Mootsikapun P, Hsueh PR, Talwar D, Co VM, Rajadhyaksha V, Ong ML. Intravenous anidulafungin followed optionally by oral voriconazole for the treatment of candidemia in Asian patients: results from an open-label Phase III trial. BMC Infect Dis. 2013 May 15;13:219. doi: 10.1186/1471-2334-13-219.