Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) - Study Results

Voriconazole Versus Itraconazole In Primary Prophylaxis Of Invasive Fungal Infection (IFI) In Subjects With Allogeneic Hematopoietic Stem Cell Transplants (HSCT) (IMPROVIT)

This study has been completed.

Study NCT00289991 Information provided by Pfizer

First Received on February 9, 2006. Last Updated on March 26, 2010 History of Changes

Results First Received: February 9, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Antifungal Prophylaxis of Invasive Fungal Infections
Interventions:	Drug: Itraconazole Drug: Vfend - voriconazole

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were stratified at the time of randomization by the following factors: conditioning regimen (myeloablative or non-myeloablative); relatedness of donor (matched/related or mismatched/unrelated).

Reporting Groups

	Description
Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Description

Voriconazole

Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).

Itraconazole

Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Participant Flow: Overall Study

	Voriconazole	Itraconazole
STARTED	234	255
COMPLETED	176	175
NOT COMPLETED	58	80
Death	35	38
Adverse Event	15	13
Failure of prophylaxis	1	1
Fungal breakthrough infection	0	1
Lost to Follow-up	0	1
Withdrawal by Subject	2	12
Unspecified	5	14

Baseline Characteristics

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Reporting Groups

	Description
Voriconazole	Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
Itraconazole	Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.

Baseline Measures

	Voriconazole	Itraconazole	Total
Number of Participants [units: participants]	234	255	489
Age, Customized [units: participants]
<18 years	9	11	20
Between 18 and 44 years	106	119	225
Between 45 and 64 years	104	115	219
>=65 years	15	10	25
Age [units: years] Mean ± Standard Deviation	43.3 ± 14.4	42.7 ± 14.6	43.0 ± 14.5
Gender [units: participants]
Female	96	100	196
Male	138	155	293

Outcome Measures

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1. Primary:

Success at Day 180: Percent of Responders (Randomization Strata) [ Time Frame: Day 180 (Visit 9) ]

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2. Secondary:

Success at Day 100: Percent of Responders (Randomization Strata) [ Time Frame: Day 100 (Visit 7) ]

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3. Secondary:

Time to Breakthrough Invasive Fungal Infection (IFI) [ Time Frame: Day 1 up to Day 180 (Visit 9) ]

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4. Secondary:

Percent of Subjects With Occurrence of Breakthrough IFI [ Time Frame: Day 1 up to Day 100 (Visit 7) and Day 180 (Visit 9) ]

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5. Secondary:

Survival: Percent of Subjects Who Died at or Before Day 180 [ Time Frame: Day 1 up to Day 180 (Visit 9) ]

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6. Secondary:

Time to Discontinuation of Study Treatment [ Time Frame: Day 1 up to Day 180 (Visit 9) ]

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7. Secondary:

Survival: Percent of Subjects Who Died Within 1 Year [ Time Frame: Day 1 up to 1 year (Day 365) ]

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8. Secondary:

Duration of Treatment [ Time Frame: Day 1 up to Day 180 ]

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9. Secondary:

Percent of Subjects With Use of Other Systemic Antifungal Agents as Empirical or Therapeutic Treatment [ Time Frame: Day 1 up to Day 180 ]

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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:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
Data was excluded from 1 site due to Good Clinical Practices deviations.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00289991 History of Changes
Other Study ID Numbers:	A1501073
Study First Received:	February 9, 2006
Results First Received:	February 9, 2010
Last Updated:	March 26, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency