Trial Outcomes & Findings for Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections (NCT NCT00418951)

Last Updated: 2012-08-07

Results Overview

Endpoint was whether participant had an invasive fungal infection or not, a potentially fatal complication with leukemia patients. Efficacy defined as absence of proven and probable fungal infection. Probable fungal infection is: 1) Positive radiographic findings consistent with fungal infections documented on CT imaging: Lower respiratory tract infection: halo sign, air crescent-sign, or cavity within areas of consolidation; Sinus: erosion of sinus walls or extension of infection to neighboring structures, extensive skull base destruction; and/or 2) Two positive galactomannan index test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

120 participants

Primary outcome timeframe

35 days from the start of therapy for induction participants and 42 days for salvage participants.

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 11/3/2006 to 8/4/09. All patients registered at The University of Texas M.D. Anderson Cancer Center.

Eight of 120 patients registered never received study drug, therefore were excluded from the study.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	39	33	40
Overall Study COMPLETED	39	33	40
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Amphotericin B: 3 mg/kg n=39 Participants 3 mg/kg intravenously (IV) three times per week	Liposomal Amphotericin B: 9 mg/kg n=33 Participants 9 mg/kg IV once per week	Voriconazole: 400 mg n=40 Participants 400 mg oral twice daily day 1 followed by 200 mg twice daily	Total n=112 Participants Total of all reporting groups
Age Continuous	60 years n=93 Participants	71 years n=4 Participants	71 years n=27 Participants	60 years n=483 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	16 Participants n=4 Participants	19 Participants n=27 Participants	54 Participants n=483 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	17 Participants n=4 Participants	21 Participants n=27 Participants	58 Participants n=483 Participants
Region of Enrollment United States	39 participants n=93 Participants	33 participants n=4 Participants	40 participants n=27 Participants	112 participants n=483 Participants

PRIMARY outcome

Timeframe: 35 days from the start of therapy for induction participants and 42 days for salvage participants.

Population: Outcome evaluability required at least two doses of study drug.

Outcome measures

Outcome measures
Measure	Liposomal Amphotericin B: 3 mg/kg n=35 Participants 3 mg/kg intravenously (IV) three times per week	Liposomal Amphotericin B: 9 mg/kg n=28 Participants 9 mg/kg IV once per week	Voriconazole: 400 mg n=39 Participants 400 mg oral twice daily day 1 followed by 200 mg twice daily
Number of Participants With Invasive Fungal Infection	3 participants	4 participants	2 participants

Adverse Events

Liposomal Amphotericin B: 3 mg/kg

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Liposomal Amphotericin B: 9 mg/kg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Voriconazole: 400 mg

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Liposomal Amphotericin B: 3 mg/kg n=39 participants at risk 3 mg/kg intravenously (IV) three times per week	Liposomal Amphotericin B: 9 mg/kg n=33 participants at risk 9 mg/kg IV once per week	Voriconazole: 400 mg n=40 participants at risk 400 mg oral twice daily day 1 followed by 200 mg twice daily
Cardiac disorders Supravnetricular Tachycardia	5.1% 2/39 • Number of events 2 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
General disorders Death	5.1% 2/39 • Number of events 2 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	5.0% 2/40 • Number of events 2 • Three years, ten months.
General disorders Allergic Reaction	0.00% 0/39 • Three years, ten months.	3.0% 1/33 • Number of events 1 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
Hepatobiliary disorders Hyperbilirubinemia	2.6% 1/39 • Number of events 1 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	2.5% 1/40 • Number of events 1 • Three years, ten months.
Renal and urinary disorders Acute Renal Failure	2.6% 1/39 • Number of events 1 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	2.6% 1/39 • Number of events 1 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
Infections and infestations Infection Sepsis	2.6% 1/39 • Number of events 1 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
General disorders Chest Pain	0.00% 0/39 • Three years, ten months.	3.0% 1/33 • Number of events 1 • Three years, ten months.	0.00% 0/40 • Three years, ten months.
Hepatobiliary disorders Elevated alanine aminotransferase	0.00% 0/39 • Three years, ten months.	0.00% 0/33 • Three years, ten months.	2.5% 1/40 • Number of events 1 • Three years, ten months.

Other adverse events

Adverse event data not reported

Additional Information

Jorge Cortes, MD / Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-745-5783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place