Invasive Fungal InfectionsNCT03174457
Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study
An observational study of Invasive Fungal Infections, run by Astellas Pharma Singapore Pte. Ltd. at 16 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 21 Jun 2017to 31 May 2018
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections
Who may be able to join
- 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.
Who cannot join
- The patient is receiving micafungin treatment in combination with other antifungal drugs.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Taiwan6 sites
Site TW606
Changhua
Site TW603
Taichung
Site TW605
Taichung
Site TW601
Taipei
Site TW604
Taipei
Site TW602
Taoyuan
South Korea4 sites
Site KR401
Seoul
Site KR402
Seoul
Site KR403
Seoul
Site KR404
Seoul
About this study
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
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.
Read the 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
- Invasive Fungal Infections
- Being tested
- Micafungin
- Keywords
- Oesophageal Candidiasis, Paediatric, Invasive Candidiasis, Prophylaxis of Candida Infections, Candidemia, Aspergillosis, Micafungin
- Medical subject headings
- Invasive Fungal Infections, Candidiasis, Invasive, Candidemia, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Also called micafungin sodium, Mycamine, FK463
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Treatment: micafungin | Participants receive once daily by intravenous infusion. Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to end of trial (up to 95 weeks)
Secondary outcomes (4)
Safety assessed by nature, frequency and severity of Adverse Events (AEs)
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
Measured: Up to end of trial (up to 95 weeks)
Overall treatment success
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
Measured: Up to end of trial (up to 95 weeks)
Change from baseline to end of treatment in safety laboratory parameters
Indication of hepatic or renal dysfunction
Measured: 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
Response will be defined as eradication, presumed eradication, or overall
Measured: Up to end of trial (up to 95 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start21 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Singapore Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174457
- Sponsor's protocol ID
- 9463-MA-1006
- Status last verified
- Oct 2018
- First submitted
- 31 May 2017
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03174457
- Acronym / sponsor ID
- 9463-MA-1006
- Conditions
- Invasive Fungal Infections
- Keywords
- Oesophageal Candidiasis, Paediatric, Invasive Candidiasis, Prophylaxis of Candida Infections, Candidemia, Aspergillosis, Micafungin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: micafungin | – | Drug: MicafunginParticipants receive once daily by intravenous infusion. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- The patient is receiving micafungin treatment in combination with other antifungal drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicafunginAlso: micafungin sodium, Mycamine, FK463Intravenous | Drug | Treatment: micafungin |
Primary outcome
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
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
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
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
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
4 secondary outcomes
Safety assessed by nature, frequency and severity of Adverse Events (AEs)
Time frame: Up to end of trial (up to 95 weeks)
Overall treatment success
Time frame: Up to end of trial (up to 95 weeks)
Change from baseline to end of treatment in safety laboratory parameters
Time frame: 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
Time frame: Up to end of trial (up to 95 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Singapore Pte. Ltd.
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infections, run by Astellas Pharma Singapore Pte. Ltd. at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Taiwan, South Korea, Thailand, Hong Kong, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period (time frame: Up to end of trial (up to 95 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.