Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
- Registration Number
- NCT03174457
- Lead Sponsor
- Astellas Pharma Singapore Pte. Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- The patient is receiving micafungin treatment in combination with other antifungal drugs.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment: micafungin Micafungin Participants receive once daily by intravenous infusion.
- Primary Outcome Measures
Name Time Method Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment) Up to end of trial (up to 95 weeks) This includes hepatic dysfunction, renal dysfunction, infusion-related reactions, haemolytic events, histamine-release/allergic-type reactions and injection site reactions
Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period Up to end of trial (up to 95 weeks) 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
Incidence of death attributable to micafungin treatment Up to end of trial (up to 95 weeks) Death, if considered by the clinician to be attributable to micafungin
Safety assessed by incidence of Serious Adverse Events (SAEs) Up to end of trial (up to 95 weeks) 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
Safety assessed by vital sign measurements Up to end of trial (up to 95 weeks) Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature
- Secondary Outcome Measures
Name Time Method Change from baseline to end of treatment in safety laboratory parameters Up to end of trial (up to 95 weeks) Indication of hepatic or renal dysfunction
Safety assessed by nature, frequency and severity of Adverse Events (AEs) Up to end of trial (up to 95 weeks) 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
Overall treatment success Up to end of trial (up to 95 weeks) 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
Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species Up to end of trial (up to 95 weeks) Response will be defined as eradication, presumed eradication, or overall
Trial Locations
- Locations (16)
Site TW601
🇨🇳Taipei, Taiwan
Site TW604
🇨🇳Taipei, Taiwan
Site KR401
🇰🇷Seoul, Korea, Republic of
Site SG801
🇸🇬Singapore, Singapore
Site TW606
🇨🇳Changhua, Taiwan
Site TW603
🇨🇳Taichung, Taiwan
Site KR402
🇰🇷Seoul, Korea, Republic of
Site KR404
🇰🇷Seoul, Korea, Republic of
Site TW602
🇨🇳Taoyuan, Taiwan
Site TH703
🇹🇭Bangkok, Thailand
Site TH704
🇹🇭Chiang Mai, Thailand
Site KR403
🇰🇷Seoul, Korea, Republic of
Site HK202
🇭🇰Pok Fu Lam, Hong Kong
Site TW605
🇨🇳Taichung, Taiwan
Site TH701
🇹🇭Bangkok, Thailand
Site HK203
🇭🇰New Territories, Hong Kong