Trials / Completed
CompletedNCT03174457
Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Astellas Pharma Singapore Pte. Ltd. · Industry
- Sex
- All
- Age
- 0 Years – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Micafungin | Intravenous |
Timeline
- Start date
- 2017-06-21
- Primary completion
- 2018-05-31
- Completion
- 2018-05-31
- First posted
- 2017-06-02
- Last updated
- 2024-10-21
Locations
16 sites across 5 countries: Hong Kong, Singapore, South Korea, Taiwan, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03174457. Inclusion in this directory is not an endorsement.