Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

This study has been completed.

Study NCT00418951 Information provided by M.D. Anderson Cancer Center

First Received on January 3, 2007. Last Updated on May 25, 2011 History of Changes

Results First Received: April 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Acute Myelogenous Leukemia Myelodysplastic Syndrome
Interventions:	Drug: Voriconazole Drug: Liposomal amphotericin B

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 11/3/2006 to 8/4/09. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eight of 120 patients registered never received study drug, therefore were excluded from the study.

Reporting Groups

	Description
Liposomal Amphotericin B: 3 mg/kg	3 mg/kg intravenously (IV) three times per week
Liposomal Amphotericin B: 9 mg/kg	9 mg/kg IV once per week
Voriconazole: 400 mg	400 mg oral twice daily day 1 followed by 200 mg twice daily

Participant Flow: Overall Study

	Liposomal Amphotericin B: 3 mg/kg	Liposomal Amphotericin B: 9 mg/kg	Voriconazole: 400 mg
STARTED	39	33	40
COMPLETED	39	33	40
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Liposomal Amphotericin B: 3 mg/kg	3 mg/kg intravenously (IV) three times per week
Liposomal Amphotericin B: 9 mg/kg	9 mg/kg IV once per week
Voriconazole: 400 mg	400 mg oral twice daily day 1 followed by 200 mg twice daily

Baseline Measures

	Liposomal Amphotericin B: 3 mg/kg	Liposomal Amphotericin B: 9 mg/kg	Voriconazole: 400 mg	Total
Number of Participants [units: participants]	39	33	40	112
Age [units: years] Median ( Full Range )	60 ( 25 to 84 )	71 ( 23 to 78 )	71 ( 19 to 80 )	60 ( 19 to 84 )
Gender [units: participants]
Female	19	16	19	54
Male	20	17	21	58
Region of Enrollment [units: participants]
United States	39	33	40	112

Outcome Measures

1. Primary:

Number of Participants With Invasive Fungal Infection [ Time Frame: 35 days from the start of therapy for induction participants and 42 days for salvage participants. ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Jorge Cortes, MD / Professor
Organization: The University of Texas MD Anderson Cancer Center
phone: 713-745-5783
e-mail: eharrison@mdanderson.org

No publications provided

Responsible Party:	Jorge Cortes, MD / Professor, U.T. M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00418951 History of Changes
Other Study ID Numbers:	2006-0536
Study First Received:	January 3, 2007
Results First Received:	April 15, 2011
Last Updated:	May 25, 2011
Health Authority:	United States: Institutional Review Board