A Study Of The Efficacy And Safety Of Anidulafungin Vs. F... | NCT01176058

NCT01176058

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
open label	Active Comparator		Drug: Anidulafungin/Fluconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anidulafungin/Fluconazole	Drug	Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days	open label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)	Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.	End of Intravenous Treatment (Up to Day 42)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Global Response at End of Treatment (EOT)	Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response). Failure - Any case that did not meet the criteria for success.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nanfang Hospital		Guangzhou	Guangdong	510515	China
Nanjing General Hospital of Nanjing Military Command/Respiratory Department

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
BG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0018 BG00217

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

Between 18 and 44 years

Title	Measurements
	BG0001 BG0014 BG0025

Between 45 and 64 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0013 BG002

Presence of Signs and Symptoms of Candidemia

Each participant could have been counted in more than 1 category for the signs and symptoms of Candidemia.

Number

participants

Title

Denominators

Categories

Fever

Title	Measurements
	BG0007 BG0017 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)

Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available [N/A] for a participant with a successful clinical response).

Failure - Any case that did not meet the criteria for success.

Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Intravenous Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Units	Counts
Participants	OG0008 OG0017

Title

Denominators

Categories

Success

Title	Measurements
	OG00062.50(29.0 to 96.0) OG00171.43(38.0 to 100.0)

Failure

Title	Measurements
	OG000

Secondary

Percentage of Participants With Global Response at End of Treatment (EOT)

Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).

Failure - Any case that did not meet the criteria for success.

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Clinical Response at EOIT

Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Intravenous Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Clinical Response at EOT

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Clinical Response at Follow-Up

MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

Post treatment follow-up visit (Up to Day 52)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Microbiological Response at EOIT

Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Intravenous Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Microbiological Response at EOT

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

End of Treatment (Up to Day 42)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Percentage of Participants With Microbiological Response at Follow-Up

MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.

Posted

Number

95% Confidence Interval

percentage of participants

Post treatment follow-up visit (Up to Day 52)

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Secondary

Number of Participants Who Died

Safety population: All participants who have received at least one dose of study medication.

Posted

Number

participants

Baseline to Day 52

ID	Title	Description
OG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
OG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Anidulafungin	Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.			2	9	6	9
EG001	Fluconazole	IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.			0	8	6	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment		EG0001 affected9 at risk EG0010 affected8 at risk
Disease progression	General disorders	MedDRA 14.1	Non-systematic Assessment		EG0001 affected9 at risk EG0010 affected8 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Supraventricular tachycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0012 affected8 at risk
Intestinal obsturction	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0011 affected8 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0012 affected8 at risk
Chest discomfort	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0011 affected8 at risk
Chills	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Pyrexia	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected9 at risk EG0011 affected8 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Nasopharyngitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0011 affected8 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
C-reactive protein increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
White blood cell count increased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0002 affected9 at risk EG0010 affected8 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0012 affected8 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0011 affected8 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected9 at risk EG0010 affected8 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Insomnia	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0011 affected8 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Proteinuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected9 at risk EG0011 affected8 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected9 at risk EG0010 affected8 at risk

Due to small enrollment, the per-protocol population was not determined, and analysis was performed on the mITT population.

Certain Agreements

ID	Term
D058387	Candidemia

Ancestor Terms

ID	Term
D058365	Candidiasis, Invasive
D002177	Candidiasis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000072742	Invasive Fungal Infections
D016469	Fungemia
D018805	Sepsis
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000077612	Anidulafungin
D015725	Fluconazole

Ancestor Terms

ID	Term
D054714	Echinocandins
D010456	Peptides, Cyclic
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

OG00128.57(0.0 to 62.0)

Units	Counts
Participants	OG0008 OG0017

Units	Counts
Participants	OG0008 OG0017

Units	Counts
Participants	OG0008 OG0017