Clinical trial NCT03174457: Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Fungal Infections
Keywords: Oesophageal Candidiasis
Paediatric
Invasive Candidiasis
Prophylaxis of Candida Infections
Candidemia
Aspergillosis
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period
timeFrame: Up to end of trial (up to 95 weeks)
measure: Safety assessed by incidence of Serious Adverse Events (SAEs)
timeFrame: Up to end of trial (up to 95 weeks)
measure: Incidence of death attributable to micafungin treatment
timeFrame: Up to end of trial (up to 95 weeks)
measure: Safety assessed by vital sign measurements
timeFrame: Up to end of trial (up to 95 weeks)
measure: Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)
timeFrame: Up to end of trial (up to 95 weeks)
Secondary outcomes:
measure: Safety assessed by nature, frequency and severity of Adverse Events (AEs)
timeFrame: Up to end of trial (up to 95 weeks)
measure: Overall treatment success
timeFrame: Up to end of trial (up to 95 weeks)
measure: Change from baseline to end of treatment in safety laboratory parameters
timeFrame: Up to end of trial (up to 95 weeks)
measure: Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species
timeFrame: Up to end of trial (up to 95 weeks)
Other outcomes:
Locations:
city: New Territories
country: Hong Kong
facility: Site HK203
city: Pok Fu Lam
country: Hong Kong
facility: Site HK202
city: Seoul
country: Korea, Republic of
facility: Site KR401
city: Seoul
country: Korea, Republic of
facility: Site KR402
city: Seoul
country: Korea, Republic of
facility: Site KR403
city: Seoul
country: Korea, Republic of
facility: Site KR404
city: Singapore
country: Singapore
facility: Site SG801
city: Changhua
country: Taiwan
facility: Site TW606
city: Taichung
country: Taiwan
facility: Site TW603
city: Taichung
country: Taiwan
facility: Site TW605
city: Taipei
country: Taiwan
facility: Site TW601
city: Taipei
country: Taiwan
facility: Site TW604
city: Taoyuan
country: Taiwan
facility: Site TW602
city: Bangkok
country: Thailand
facility: Site TH701
city: Bangkok
country: Thailand
facility: Site TH703
city: Chiang Mai
country: Thailand
facility: Site TH704
Study officials:
affiliation: Astellas Pharma Singapore Pte. Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References: