Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Invasive Fungal Infections Clinical Trial

Official title:

Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174457
• Other study ID #: 9463-MA-1006
• Status: Completed
• Start date: June 21, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.

Description:

The study will collect safety and efficacy data from pediatric patients who are prescribed intravenous micafungin for prophylaxis. During this trial, patients with two separate indications will be treated. The first, Invasive candidiasis will have a minimum treatment of 2 weeks. The second, Oesophageal candidiasis will have a minimum treatment of 1 week. Both indications will have a follow-up period of 4 weeks after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Prescribed micafungin for prophylaxis or treatment of fungal infections.

According to treatment guidelines, micafungin may not be a suitable treatment for the following patients:

• The patient has evidence of impaired liver function: alanine aminotransferase (AST), aspartate aminotransferase (ALT) >5 times the upper limit of normal (ULN) or total bilirubin >2 times ULN.

• The patient has a history of allergy, hypersensitivity, or any serious reaction to the echinocandin class of antifungals.

• The patient has a confirmed systemic fungal infection with a non-Candida species.

Exclusion Criteria:

• The patient is receiving micafungin treatment in combination with other antifungal drugs.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Invasive Fungal Infections
• Mycoses

Intervention

Drug:
• Micafungin
Intravenous

Locations

Country	Name	City	State
Hong Kong	Site HK203	New Territories
Hong Kong	Site HK202	Pok Fu Lam
Korea, Republic of	Site KR401	Seoul
Korea, Republic of	Site KR402	Seoul
Korea, Republic of	Site KR403	Seoul
Korea, Republic of	Site KR404	Seoul
Singapore	Site SG801	Singapore
Taiwan	Site TW606	Changhua
Taiwan	Site TW603	Taichung
Taiwan	Site TW605	Taichung
Taiwan	Site TW601	Taipei
Taiwan	Site TW604	Taipei
Taiwan	Site TW602	Taoyuan
Thailand	Site TH701	Bangkok
Thailand	Site TH703	Bangkok
Thailand	Site TH704	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Singapore Pte. Ltd.

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period	ADR is considered to be any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship (drug-event) is at least a reasonable possibility	Up to end of trial (up to 95 weeks)
Primary	Safety assessed by incidence of Serious Adverse Events (SAEs)	Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event	Up to end of trial (up to 95 weeks)
Primary	Incidence of death attributable to micafungin treatment	Death, if considered by the clinician to be attributable to micafungin	Up to end of trial (up to 95 weeks)
Primary	Safety assessed by vital sign measurements	Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature	Up to end of trial (up to 95 weeks)
Primary	Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)	This includes hepatic dysfunction, renal dysfunction, infusion-related reactions, haemolytic events, histamine-release/allergic-type reactions and injection site reactions	Up to end of trial (up to 95 weeks)
Secondary	Safety assessed by nature, frequency and severity of Adverse Events (AEs)	Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs that started or worsened during the observational period after the start of micafungin treatment will be summarized by the time period of onset. AE occurring within 3 days after end of therapy will be defined as treatment emergent adverse events	Up to end of trial (up to 95 weeks)
Secondary	Overall treatment success	The overall treatment success will be defined as a complete or partial clinical response in proven fungal infection, and by an empirical treatment composite outcome score in probable/possible fungal infection. Overall treatment success for patients receiving prophylactic treatment is defined as the absence of proven, probable, possible or suspected Invasive Fungal Infection (IFI) during the period of prophylactic therapy and up to 4 weeks after stopping micafungin administration	Up to end of trial (up to 95 weeks)
Secondary	Change from baseline to end of treatment in safety laboratory parameters	Indication of hepatic or renal dysfunction	Up to end of trial (up to 95 weeks)
Secondary	Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species	Response will be defined as eradication, presumed eradication, or overall	Up to end of trial (up to 95 weeks)