Trial of Combination Antifungal Therapy (Vori+Mica vs. Vori+Placebo) in Invasive Aspergillosis

NCT01207128 | Withdrawn Phase 2 DMC

• 1 other identifier: UARK 2010-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the therapeutic effectiveness of combination antifungal therapy (CAT) of voriconazole plus micafungin versus voriconazole plus placebo equivalent as primary therapy for invasive aspergillosis (IA) in patients with hematological cancer.

Conditions

Aspergillosis

Outcome Measures

Primary Outcomes (1)

• Response

  Response is defined as normalization of the serum Aspergillus galactomannan index (GMI)values (first normal GMI value is considered day of response).

  maximum 6 weeks

Study Arms (2)

Voriconazole, Micafungin

ACTIVE COMPARATOR

Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV) Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.

Drug: Voriconazole, micafungin

Voriconazole+Micafungin or Voriconazole+Placebo

NO INTERVENTION

Voriconazole+Micafungin or Voriconazole+Placebo

Interventions

Voriconazole, micafungin DRUG

Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.

Voriconazole, Micafungin

Eligibility Criteria

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

You may qualify if:

• The patient or legally authorized representative has signed an informed consent/assent.
• Assent will be obtained as required by the UAMS IRB.
• The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI
• The patient is 18 years of age or older.

You may not qualify if:

• The patient is being treated with an unlicensed investigational drug for aspergillosis.
• The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for \> 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled.
• Patient has invasive aspergillosis but with negative Aspergillus GM index.
• The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug.
• The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal.
• The patient has hepatic cirrhosis.
• Patients with creatinine \> 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours).
• The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry.
• The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents.
• The patient has previously enrolled into this study.
• The patient has a concomitant medical condition, which in the opinion of the Investigator may create an unacceptable additional risk.
• The patient has an active microbiologically-documented deep infection due to a non-Aspergillus mold.
• The patient has a life expectancy of less than seven days.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (2)

UAMS

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Aspergillosis

Interventions

Voriconazole; Micafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

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

Study Officials

• Elias Anaissie, MD

  University of Arkansas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (2)