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NCT Number: NCT03174457

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

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.

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Key information

Conditions

Invasive Fungal Infections Aspergillosis Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site HK203, New Territories, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Micafungin

Drug

Intravenous

Other names: micafungin sodium, Mycamine, FK463

Primary outcomes

  1. Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period

    Time frame: 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

  2. Safety assessed by incidence of Serious Adverse Events (SAEs)

    Time frame: 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

  3. Incidence of death attributable to micafungin treatment

    Time frame: Up to end of trial (up to 95 weeks)

    Death, if considered by the clinician to be attributable to micafungin

  4. Safety assessed by vital sign measurements

    Time frame: Up to end of trial (up to 95 weeks)

    Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature

  5. Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Overall treatment success

    Time frame: 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

  3. Change from baseline to end of treatment in safety laboratory parameters

    Time frame: Up to end of trial (up to 95 weeks)

    Indication of hepatic or renal dysfunction

  4. Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species

    Time frame: Up to end of trial (up to 95 weeks)

    Response will be defined as eradication, presumed eradication, or overall

Sponsors and collaborators

Lead sponsor

Astellas Pharma Singapore Pte. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2017
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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