Back to results

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

Primary Purpose

Aspergillosis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Voriconazole, micafungin

About this trial

This is an interventional treatment trial for Aspergillosis

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

UAMS
University of Arkansas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Voriconazole, Micafungin

Voriconazole+Micafungin or Voriconazole+Placebo

Arm Description

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 or Voriconazole+Placebo

Outcomes

Primary Outcome Measures

Response

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01207128

First Posted

September 21, 2010

Last Updated

April 18, 2012

Sponsor

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT01207128

Brief Title

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

Official Title

A Phase II Randomized, Double Blind, Placebo-controlled, Trial of Combination Antifungal Therapy (Voriconazole Plus Micafungin vs. Voriconazole Plus Placebo Equivalent) in the Treatment of Invasive Aspergillosis (IA) in Patients With Hematological Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

None enrolled

Study Start Date

February 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

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

Aspergillosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Voriconazole, Micafungin

Arm Type

Active Comparator

Arm Description

Arm Title

Voriconazole+Micafungin or Voriconazole+Placebo

Arm Type

No Intervention

Arm Description

Voriconazole+Micafungin or Voriconazole+Placebo

Intervention Type

Drug

Intervention Name(s)

Voriconazole, micafungin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response

Description

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

Time Frame

maximum 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elias Anaissie, MD

Organizational Affiliation

University of Arkansas

Official's Role

Study Chair

Facility Information:

Facility Name

UAMS

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

University of Arkansas

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs