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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
Intravenous
Site HK203
New Territories, Hong Kong
Site HK202
Pok Fu Lam, Hong Kong
Site SG801
Singapore, Singapore
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
Time frame: Up to end of trial (up to 95 weeks)
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
Time frame: Up to end of trial (up to 95 weeks)
Incidence of death attributable to micafungin treatment
Death, if considered by the clinician to be attributable to micafungin
Time frame: Up to end of trial (up to 95 weeks)
Safety assessed by vital sign measurements
Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature
Time frame: Up to end of trial (up to 95 weeks)
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
Time frame: Up to end of trial (up to 95 weeks)
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
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Site KR401
Seoul, South Korea
Site KR402
Seoul, South Korea
Site KR403
Seoul, South Korea
Site KR404
Seoul, South Korea
Site TW606
Changhua, Taiwan
Site TW603
Taichung, Taiwan
Site TW605
Taichung, Taiwan
...and 6 more locations
Time frame: Up to end of trial (up to 95 weeks)
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
Time frame: Up to end of trial (up to 95 weeks)
Change from baseline to end of treatment in safety laboratory parameters
Indication of hepatic or renal dysfunction
Time frame: Up to end of trial (up to 95 weeks)
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
Time frame: Up to end of trial (up to 95 weeks)