NCT00761267|CompletedPhase 3ResultsDMCFDA Drug

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

A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

Pfizer ClinicalTrials.gov

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2 other identifiers

A88510082008-004150-32

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredSep 2008

StartedFeb 2009

CompletionFeb 2018

Brief Summary

Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Feb 2009

Longer than P75 for phase_3

Geographic Reach

10 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 years study duration

First Submitted

Initial submission to the registry

September 25, 2008

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed

4 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed

9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

8 months until next milestone

Results Posted

Study results publicly available

September 14, 2018

Completed

Last Updated

April 4, 2019

Status Verified

March 1, 2019

Enrollment Period

9 years

First QC Date

September 25, 2008

Results QC Date

August 14, 2018

Last Update Submit

March 19, 2019

Conditions

Candidemia

Keywords

Anidulafunginpediatricscandidemiainvasive candidiasissafety

Outcome Measures

Primary Outcomes (2)

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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).
Baseline up to 6 weeks after EOT (up to 91 days)
Number of Participants With Laboratory Abnormalities
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).
Baseline up to 6 weeks after EOT (up to 91 days)

Secondary Outcomes (13)

Number of Participants With Global Response
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)
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup
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
Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup
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
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
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
Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup
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
+8 more secondary outcomes

Study Arms (1)

Anidulafungin IV

EXPERIMENTAL

All subjects meeting screening criteria will receive IV anidulafungin.

Drug: AnidulafunginDrug: Fluconazole

Interventions

AnidulafunginDRUG

Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Maximum treatment duration with anidulafungin is 35 days.

Also known as: Eraxis

Anidulafungin IV

FluconazoleDRUG

Subjects may be switched to oral fluconazole \[6-12 mg/kg/day (not to exceed 800mg/day\] provided they meet specified criteria. Maximum total treatment duration is 49 days.

Also known as: Diflucan

Anidulafungin IV

Eligibility Criteria

Age1 Month - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Subject must be either (1) at high risk for candidiasis (1 month - \< 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)
Male and female patients from 1 month to less than 18 years of age.

You may not qualify if:

Any patients with allergy to the drug; and any pregnant female or lactating.
Failed previous antifungal therapy or expected to live \< 3 days.
Patients with documented or suspected Candida meningitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (45)

Miller Children's Hospital Bickerstaff Pediatric Family Center

Long Beach, California, 90806, United States

Location

University of California - Los Angeles

Los Angeles, California, 90095-1752, United States

Location

University of California - Los Angeles - Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

University of California - Los Angeles - Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Children's Hospital & Research Center Oakland (CHRCO)

Oakland, California, 94609, United States

Location

Children's Hospital of Orange County - Inpatient Pharmacy

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals of Cleveland Laboratory University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Le Bonheur Children's Hospital - 4th Floor