Trial Outcomes & Findings for Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis (NCT NCT00761267)

Last Updated: 2019-04-04

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

70 participants

Primary outcome timeframe

Baseline up to 6 weeks after EOT (up to 91 days)

Results posted on

2019-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
Overall Study STARTED	20	20	30
Overall Study Treated	19	19	30
Overall Study COMPLETED	18	16	24
Overall Study NOT COMPLETED	2	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.
Overall Study Death	1	2	5
Overall Study Lost to Follow-up	0	0	1
Overall Study Randomized but not treated	1	1	0
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=19 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	Total n=68 Participants Total of all reporting groups
Age, Continuous	0.93 years STANDARD_DEVIATION 0.52 • n=5 Participants	3.09 years STANDARD_DEVIATION 0.68 • n=7 Participants	10.67 years STANDARD_DEVIATION 3.68 • n=5 Participants	5.83 years STANDARD_DEVIATION 5.05 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	30 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	15 Participants n=7 Participants	20 Participants n=5 Participants	54 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to 6 weeks after EOT (up to 91 days)

Population: The safety population included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=19 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	17 Participants	19 Participants	30 Participants	—	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	7 Participants	10 Participants	13 Participants	—	—

PRIMARY outcome

Timeframe: Baseline up to 6 weeks after EOT (up to 91 days)

Population: The safety population included all randomized participants who received at least 1 dose of study medication.

Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.EOT visit defined as last day of study treatment (IV or oral).

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=19 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Number of Participants With Laboratory Abnormalities	19 Participants	18 Participants	30 Participants	—	—

SECONDARY outcome

Timeframe: End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)

Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.

Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection\[CI\]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral).

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=16 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=18 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Number of Participants With Global Response EOIVT · Success	11 Participants	14 Participants	20 Participants	—	—
Number of Participants With Global Response EOIVT · Failure	2 Participants	1 Participants	3 Participants	—	—
Number of Participants With Global Response EOIVT · Indeterminate	3 Participants	3 Participants	7 Participants	—	—
Number of Participants With Global Response EOIVT · Missing	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Global Response EOT · Success	11 Participants	14 Participants	21 Participants	—	—
Number of Participants With Global Response EOT · Failure	2 Participants	1 Participants	3 Participants	—	—
Number of Participants With Global Response EOT · Indeterminate	3 Participants	3 Participants	6 Participants	—	—
Number of Participants With Global Response EOT · Missing	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Global Response 2 week follow-up · Success	11 Participants	13 Participants	22 Participants	—	—
Number of Participants With Global Response 2 week follow-up · Failure	2 Participants	1 Participants	4 Participants	—	—
Number of Participants With Global Response 2 week follow-up · Indeterminate	3 Participants	1 Participants	0 Participants	—	—
Number of Participants With Global Response 2 week follow-up · Missing	0 Participants	3 Participants	4 Participants	—	—
Number of Participants With Global Response 6 week follow-up · Success	11 Participants	12 Participants	20 Participants	—	—
Number of Participants With Global Response 6 week follow-up · Failure	2 Participants	2 Participants	6 Participants	—	—
Number of Participants With Global Response 6 week follow-up · Indeterminate	3 Participants	2 Participants	0 Participants	—	—
Number of Participants With Global Response 6 week follow-up · Missing	0 Participants	2 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion

Population: PK subgroup population included the first 6 participants aged between 1 month to \<2 years.

Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=6 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup	66449.1 nanogramhour per milliliter (nghr/mL) Geometric Coefficient of Variation 28	—	—	—	—

SECONDARY outcome

Timeframe: Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion

Population: PK subgroup population included the first 6 participants aged between 1 month to \<2 years.

Cmax was obtained directly from the observed concentration data on Day 2.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=6 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup	5963.53 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 29	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose

Population: The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years.

Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=8 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup	NA ng*hr/mL Geometric Coefficient of Variation NA Only one value was above LLOQ, hence, AUC24 of polysorbate 80 could not be calculated.	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose

Population: The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years.

Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=8 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup	NA ng/mL Geometric Coefficient of Variation NA Only one value was above LLOQ, hence, Cmax of polysorbate 80 could not be calculated.	—	—	—	—

SECONDARY outcome

Timeframe: Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion

Population: PK population included all those participants who had 1 or more PK samples available.

AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=17 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin	69.87 microgramhour per milliliter(mcghr/ml) Standard Deviation 17.65	82.81 microgramhour per milliliter(mcghr/ml) Standard Deviation 31.9	86.77 microgramhour per milliliter(mcghr/ml) Standard Deviation 31.12	—	—

SECONDARY outcome

Population: PK population included all those participants who had 1 or more PK samples available.

Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=17 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin	1.98 microgram per milliliter (mcg/ml) Standard Deviation 0.58	2.51 microgram per milliliter (mcg/ml) Standard Deviation 1.11	2.52 microgram per milliliter (mcg/ml) Standard Deviation 0.96	—	—

SECONDARY outcome

Timeframe: Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days)

Population: Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.

The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=13 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=18 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=14 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) n=10 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) n=11 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)	1 Participants	3 Participants	5 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline to EOIVT (maximum of 35 days)

Population: Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available.

The probability of having at least one GI adverse event whilst on Anidulafungin treatment was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=13 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=18 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=14 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) n=10 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) n=11 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Number of Participants With Greater Than or Equal to 1 Gastro-Intestinal (GI) Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss)	5 Participants	10 Participants	6 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: EOIVT (maximum of 35 days) and EOT (maximum of 49 days)

Population: mITT population: participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. Here "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and 'Number analyzed' = Participants evaluable for this outcome measure at specified categories.

The probabilities of a global response of success or failure were compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. For the analysis of this outcome measure, global response was categorized as: success or failure. Success defined as clinical response (CR) of cure (resolution of signs, symptoms attributed to Candida infection \[CI\]). Failure defined as CR of failure (no significant improvement in signs symptoms/ death due to CI) and/or microbiological failure (persistence/new infection at follow-up/relapse of infection at follow-up).

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=10 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=15 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=9 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) n=8 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) n=8 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) EOT: Failure	0 percentage of participants	6.67 percentage of participants	22.22 percentage of participants	12.5 percentage of participants	12.5 percentage of participants
Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) EOIVT: Success	100 percentage of participants	93.33 percentage of participants	77.78 percentage of participants	87.5 percentage of participants	85.71 percentage of participants
Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) EOIVT: Failure	0 percentage of participants	6.67 percentage of participants	22.22 percentage of participants	12.5 percentage of participants	14.29 percentage of participants
Percentage of Participants With Global Response Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) EOT: Success	100 percentage of participants	93.33 percentage of participants	77.78 percentage of participants	87.5 percentage of participants	87.5 percentage of participants

SECONDARY outcome

Timeframe: During 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)

Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.

Relapse was defined as any baseline Candida species isolated following eradication (documented or presumed); or culture data not available for a participant with a clinical response of failure after a previous response of success. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection. Participants had received at least 3 doses of study medication to be classified as a failure. Clinical response of success was defined as resolution of sign and symptoms attributed to Candida infection occurred with no additional systemic or oral antifungal treatment required to complete the course of therapy. Eradication or presumed eradication: baseline pathogen not isolated from original site culture(s), or culture data are not available for a participant with successful clinical outcome. End of treatment visit defined as last day of study treatment (IV or oral).

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=16 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=18 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Percentage of Participants With Relapsed Response 2 week follow-up	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Participants With Relapsed Response 6 week follow-up	0.0 percentage of participants	5.6 percentage of participants	6.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: During 2 week follow-up (up to 63 days) and 6 week follow-up (up to 91 days) after EOT

Population: The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection.

New infection was defined as a participant presenting with clinical failure with the emergence of new Candida species at the original site of infection or at a distant site of infection. Clinical response of failure was defined as no significant improvement in signs and symptoms, or death due to the Candida infection occurred. Participants had received at least 3 doses of study medication to be classified as a failure. End of treatment visit defined as last day of study treatment (IV or oral).

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=16 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=18 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
Percentage of Participants With New Infection 2 week follow-up	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Participants With New Infection 6 week follow-up	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Overall treatment period (up to 49 days); during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days)

Population: The safety population included all randomized participants who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years n=19 Participants Participants received Anidulafungin loading dose of 3 milligrams per kg(mg/kg) intravenously(IV) on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed invasive candidiasis/candidemia(ICC) and who fulfilled protocol specified criteria \[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC,could switch to oral fluconazole(6-12 mg/kg/day,maximum 800mg/day) upto 49 days. First 6 participants received second antifungal agent, if required at Investigator's discretion.	Anidulafungin: Participants Aged 2 to <5 Years n=19 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria \[1)afebrile for \>=24 2hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\] and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) for upto 49 days.	Anidulafungin: Participants Aged 5 to <18 Years n=30 Participants Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days. After \>=10 days treatment, participants with microbiologically confirmed ICC and who fulfilled protocol specified criteria (\[1)afebrile for \>=24 hours, 2)tolerate oral medication, 3)documentation of 2 blood cultures \[24 hours apart\] negative for Candida, 4)eradication/presumed eradication of Candida from other infection sites,identified at enrollment,5)specific Candida isolate susceptible/presumed susceptible to fluconazole, 6)switched to oral fluconazole if improvement in signs,symptoms of Candida infection\]and after \>=5 days treatment, participants without microbiologically confirmed ICC, could switch to oral fluconazole (6-12 mg/kg/day, maximum 800mg/day) upto 49 days.	AUC0-24ss (>89-109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 89 to 109 mcg\h/ml).	AUC0-24ss (>109 mcghr/ml) Participants received Anidulafungin loading dose of 3mg/kg, IV on Day 1 and maintenance dose of 1.5mg/kg, every 24 hours for minimum 10 and maximum 35 days and having AUC0-24ss (more than 109 mcg\h/ml).
All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits overall study treatment period	0 Participants	1 Participants	4 Participants	—	—
All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits 2 Week Follow-up	0 Participants	0 Participants	1 Participants	—	—
All-Cause Mortality - Number of Participants Who Died During Overall Study Treatment Period and Follow-Up Visits 6 Week Follow-up	1 Participants	1 Participants	0 Participants	—	—

Adverse Events

Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years

Serious events: 7 serious events

Other events: 17 other events

Deaths: 1 deaths

Anidulafungin: Participants Aged 2 to <5 Years

Serious events: 10 serious events

Other events: 17 other events

Deaths: 2 deaths

Anidulafungin: Participants Aged 5 to <18 Years

Serious events: 13 serious events

Other events: 30 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER