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

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ClinicalTrials.gov Identifier: NCT03174457
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. )

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
Invasive Fungal Infections Drug: Micafungin

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 Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
Actual Study Start Date : June 21, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018


Group/Cohort Intervention/treatment
Treatment: micafungin
Participants receive once daily by intravenous infusion.
Drug: Micafungin
Intravenous
Other Names:
  • micafungin sodium
  • Mycamine
  • FK463




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174457


Locations
Hong Kong
Site HK203
New Territories, Hong Kong
Site HK202
Pok Fu Lam, Hong Kong
Korea, Republic of
Site KR401
Seoul, Korea, Republic of
Site KR402
Seoul, Korea, Republic of
Site KR403
Seoul, Korea, Republic of
Site KR404
Seoul, Korea, Republic of
Singapore
Site SG801
Singapore, Singapore
Taiwan
Site TW606
Changhua, Taiwan
Site TW603
Taichung, Taiwan
Site TW605
Taichung, Taiwan
Site TW601
Taipei, Taiwan
Site TW604
Taipei, Taiwan
Site TW602
Taoyuan, Taiwan
Thailand
Site TH701
Bangkok, Thailand
Site TH703
Bangkok, Thailand
Site TH704
Chiang Mai, Thailand
Sponsors and Collaborators
Astellas Pharma Singapore Pte. Ltd.
Investigators
Study Director: Medical Director Astellas Pharma Singapore Pte. Ltd.

Responsible Party: Astellas Pharma Singapore Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03174457     History of Changes
Other Study ID Numbers: 9463-MA-1006
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. ):
Oesophageal Candidiasis
Paediatric
Invasive Candidiasis
Prophylaxis of Candida Infections
Candidemia
Aspergillosis
Micafungin

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents