Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Treatment: micafungin Participants receive once daily by intravenous infusion. |
Drug: Micafungin
Intravenous
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 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
- 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
Secondary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site HK203 | New Territories | Hong Kong | ||
| 2 | Site HK202 | Pok Fu Lam | Hong Kong | ||
| 3 | Site KR401 | Seoul | Korea, Republic of | ||
| 4 | Site KR402 | Seoul | Korea, Republic of | ||
| 5 | Site KR403 | Seoul | Korea, Republic of | ||
| 6 | Site KR404 | Seoul | Korea, Republic of | ||
| 7 | Site SG801 | Singapore | Singapore | ||
| 8 | Site TW606 | Changhua | Taiwan | ||
| 9 | Site TW603 | Taichung | Taiwan | ||
| 10 | Site TW605 | Taichung | Taiwan | ||
| 11 | Site TW601 | Taipei | Taiwan | ||
| 12 | Site TW604 | Taipei | Taiwan | ||
| 13 | Site TW602 | Taoyuan | Taiwan | ||
| 14 | Site TH701 | Bangkok | Thailand | ||
| 15 | Site TH703 | Bangkok | Thailand | ||
| 16 | Site TH704 | Chiang Mai | Thailand |
Sponsors and Collaborators
- Astellas Pharma Singapore Pte. Ltd.
Investigators
- Study Director: Medical Director, Astellas Pharma Singapore Pte. Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 9463-MA-1006