This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00548262

First received: October 19, 2007

Last updated: December 15, 2010

Last verified: December 2010

History of Changes

Results First Received: October 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Candidemia Invasive Candidiasis
Interventions:	Drug: Anidulafungin Drug: 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
The planned sample size for this study was 210 subjects; however, due to slow enrollment, only 54 subjects were screened and randomized.

Reporting Groups

	Description
Anidulafungin-Voriconazole	Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.

Participant Flow: Overall Study

	Anidulafungin-Voriconazole
STARTED	54 ^[1]
COMPLETED	22 ^[2]
NOT COMPLETED	32
Death	21
Adverse Event	2
Lack of Efficacy	4
Lost to Follow-up	1
Unspecified	3
Withdrawal by Subject	1

[1]	1 participant (N) had death recorded twice; reported as 1 death in reason for discontinuation (D/C)
[2]	1 N had D/C recorded as died and as lack of efficacy; reported as lack of efficacy in reason for D/C

Baseline Characteristics

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Reporting Groups

	Description
Anidulafungin-Voriconazole	Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.

Baseline Measures

	Anidulafungin-Voriconazole
Number of Participants [units: participants]	54
Age, Customized [units: participants]
Between 18 and 44 years	18
Between 45 and 64 years	18
≥ 65 years	18
Gender [units: participants]
Female	32
Male	22

Outcome Measures

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1. Primary:

Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment [ Time Frame: End of Treatment (EOT) (up to Day 42) ]

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2. Secondary:

Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) [ Time Frame: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up ]

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3. Secondary:

Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT [ Time Frame: Baseline, EIVT (up to Day 42) ]

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4. Secondary:

Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT [ Time Frame: Baseline, EOT (up to Day 42) ]

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5. Secondary:

Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up [ Time Frame: Baseline, Week 2 Follow-up ]

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6. Secondary:

Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT [ Time Frame: Baseline, EOT (up to Day 42) ]

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7. Secondary:

Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT [ Time Frame: EIVT (up to Day 42) ]

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8. Secondary:

Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up [ Time Frame: Baseline, Week 2 Follow-up (F/U) ]

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9. Secondary:

Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score [ Time Frame: EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up ]

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10. Secondary:

Number of Participants Per Survival Status (Alive or Dead) on Day 30 [ Time Frame: Day 30 ]

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11. Secondary:

Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis [ Time Frame: Baseline to Week 6 Follow-up ]

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12. Secondary:

Time to Negative Blood, Specimen, or Tissue Culture [ Time Frame: Baseline to Week 2 Follow-up ]

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13. Secondary:

Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment [ Time Frame: Baseline to Day 42 ]

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14. Secondary:

Length of Hospital Stay [ Time Frame: Baseline to Week 6 Follow-up ]

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15. Secondary:

Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Baseline up to Week 6 Follow-up ]

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16. Secondary:

Change From Baseline in Vital Signs: Supine Blood Pressure [ Time Frame: Baseline to Week 2 Follow-up ]

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17. Secondary:

Change From Baseline in Vital Signs: Supine Heart Rate [ Time Frame: Baseline to Week 2 Follow-up ]

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18. Secondary:

Change From Baseline in Vital Signs: Weight [ Time Frame: Baseline to Week 2 Follow-up ]

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19. Secondary:

Change From Baseline in Vital Signs: Temperature [ Time Frame: Baseline to Week 2 Follow-up ]

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20. Secondary:

Change From Baseline in Vital Signs: Respiration Rate [ Time Frame: Baseline to Week 2 Follow-up ]

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21. Secondary:

Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) [ Time Frame: Baseline to Week 2 Follow-up ]

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Measure Type	Secondary
Measure Title	Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
Measure Description	Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).
Time Frame	Baseline to Week 2 Follow-up
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.

Reporting Groups

	Description
Anidulafungin-Voriconazole	Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.

Measured Values

	Anidulafungin-Voriconazole
Number of Participants Analyzed [units: participants]	27
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) [units: mg/dL] Median ( Full Range )
Baseline median: total bilirubin (n=19)	0.6 ( NA to NA ) ^[1]
Change from baseline: total bilirubin	-0.2 ( NA to NA ) ^[2]
Baseline median: direct bilirubin (n=19)	0.2 ( NA to NA ) ^[1]
Change from baseline: direct bilirubin	-0.1 ( NA to NA ) ^[2]
Baseline median: indirect bilirubin (n=17)	0.3 ( NA to NA ) ^[1]
Change from baseline: indirect bilirubin	0.0 ( NA to NA ) ^[2]
Baseline median: blood urea nitrogen (n=25)	37.4 ( NA to NA ) ^[1]
Change from baseline: blood urea nitrogen	-4.8 ( NA to NA ) ^[2]
Baseline median: creatinine (n=27)	0.8 ( NA to NA ) ^[1]
Change from baseline: creatinine	0.0 ( NA to NA ) ^[2]
Baseline median: glucose (n=24)	99 ( NA to NA ) ^[1]
Change from baseline: glucose	-6 ( NA to NA ) ^[2]

[1]	Measure of dispersion was not calculated for baseline median.
[2]	Measure of dispersion was not calculated for median change from baseline.

No statistical analysis provided for Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)

22. Secondary:

Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) [ Time Frame: Baseline to Week 2 Follow-up ]

Show Outcome Measure 22

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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
Protocol registration indicated timeframes for EIVT and/or Week 2 F/U for time to event, mortality, vital signs, and labs; however, analyses were continuous and reported from baseline to EIVT (up to Day 42), Week 2 F/U, or Week 6 telephone F/U visit.

Results Point of Contact:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00548262 History of Changes
Other Study ID Numbers:	A8851015
Study First Received:	October 19, 2007
Results First Received:	October 6, 2010
Last Updated:	December 15, 2010
Health Authority:	Brazil: Agencia Nacional de Vigilância Sanitária / Conselho Nacional de Ética em Pesquisa

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