Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

NCT03174457 | Completed FDA Drug

• 1 other identifier: 9463-MA-1006
• Study Type: observational
• Target: 120
• Locations: 5 countries
• Sites: 16

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.

Conditions

Invasive Fungal Infections

Keywords

Oesophageal Candidiasis; Paediatric; Invasive Candidiasis; Prophylaxis of Candida Infections; Candidemia; Aspergillosis; Micafungin

Outcome Measures

Primary Outcomes (5)

• 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)

Secondary Outcomes (4)

• Safety assessed by nature, frequency and severity of Adverse Events (AEs)

  Up to end of trial (up to 95 weeks)

• Overall treatment success

  Up to end of trial (up to 95 weeks)

• Change from baseline to end of treatment in safety laboratory parameters

  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

  Up to end of trial (up to 95 weeks)

Study Arms (1)

Treatment: micafungin

Participants receive once daily by intravenous infusion.

Drug: Micafungin

Interventions

Micafungin DRUG

Intravenous

Also known as: micafungin sodium, Mycamine, FK463

Treatment: micafungin

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections

You may qualify if:

• 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.

You may not qualify if:

• The patient is receiving micafungin treatment in combination with other antifungal drugs.

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (16)

Site HK203

New Territories, Hong Kong

Location

Site HK202

Pok Fu Lam, Hong Kong

Location

Site SG801

Singapore, Singapore

Location

Site KR401

Seoul, South Korea

Location

Site KR402

Seoul, South Korea

Location

Site KR403

Seoul, South Korea

Location

Site KR404

Seoul, South Korea

Location

Site TW606

Changhua, Taiwan

Location

Site TW603

Taichung, Taiwan

Location

Site TW605

Taichung, Taiwan

Location

Site TW601

Taipei, Taiwan

Location

Site TW604

Taipei, Taiwan

Location

Site TW602

Taoyuan District, Taiwan

Location

Site TH701

Bangkok, Thailand

Location

Site TH703

Bangkok, Thailand

Location

Site TH704

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Invasive Fungal Infections; Candidiasis, Invasive; Candidemia; Aspergillosis

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Candidiasis; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Medical Director

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: June 21, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 21, 2024

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2); SG (1); TW (6); TH (3); KR (4)