A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

NCT01176058 | Terminated Phase 3 Results

• 1 other identifier: A8851023
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Conditions

Candidemia

Keywords

Phase 3b; Efficacy and Safety evaluation of Anidulafungin; ICC

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)

  Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available \[N/A\] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.

  End of Intravenous Treatment (Up to Day 42)

Secondary Outcomes (8)

• Percentage of Participants With Global Response at End of Treatment (EOT)

  End of Treatment (Up to Day 42)

• Percentage of Participants With Clinical Response at EOIT

  End of Intravenous Treatment (Up to Day 42)

• Percentage of Participants With Clinical Response at EOT

  End of Treatment (Up to Day 42)

• Percentage of Participants With Clinical Response at Follow-Up

  Post treatment follow-up visit (Up to Day 52)

• Percentage of Participants With Microbiological Response at EOIT

  End of Intravenous Treatment (Up to Day 42)

Study Arms (1)

open label

ACTIVE COMPARATOR

Drug: Anidulafungin/Fluconazole

Interventions

Anidulafungin/Fluconazole DRUG

Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of candidemia or invasive candidiasis.
• Presence of one or more of signs and symptoms of acute fungal infection.

You may not qualify if:

• Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
• Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Nanjing General Hospital of Nanjing Military Command/Respiratory Department

Nanjing, Jiangsu, 210002, China

Location

Changhai Hospital, Hemotology Department

Shanghai, Shanghai Municipality, 200433, China

Location

The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology

Hangzhou, Zhejiang, 310003, China

Location

Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

Peking Union Medical College Hospital / Department of Infectious Disease

Beijing, 100730, China

Location

Institute of Antibiotics, Hua Shan Hospital, Fudan University

Shanghai, 200040, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidemia

Interventions

Anidulafungin; Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to small enrollment, the per-protocol population was not determined, and analysis was performed on the mITT population.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: October 28, 2015
• Results First Posted: September 21, 2015

Record last verified: 2015-08

Locations

CN (7)