Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: micafungin | Participants receive once daily by intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | Intravenous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
According to treatment guidelines, micafungin may not be a suitable treatment for the following patients:
Exclusion Criteria:
Not provided
Not provided
Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Singapore Pte. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site HK203 | New Territories | Hong Kong | ||||
| Site HK202 |
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | Up to end of trial (up to 95 weeks) |
| Pok Fu Lam |
| Hong Kong |
| Site SG801 | Singapore | Singapore |
| 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 |
| Site TW601 | Taipei | Taiwan |
| Site TW604 | Taipei | Taiwan |
| Site TW602 | Taoyuan | Taiwan |
| Site TH701 | Bangkok | Thailand |
| Site TH703 | Bangkok | Thailand |
| Site TH704 | Chiang Mai | Thailand |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D058365 | Candidiasis, Invasive |
| D058387 | Candidemia |
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D002177 | Candidiasis |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
Not provided
Not provided