CandidemiaPhase 4NCT01982071
A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
A Phase 4 study testing Micafungin in people with Candidemia and Candidiasis, run by Astellas Pharma China, Inc. at 15 sites in China.
Trial summary
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Candidemia, Candidiasis
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 15 sitesChina
- Study dates
- 26 Sep 2013to 28 Aug 2015
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
- The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
- The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
- Risk factor (s) of infection
- Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
- Two or more positive sputum culture for Candida
Who cannot join
- Patient received any other antifungal drug within 1 month prior to enrollment.
- HIV positive patient
- Patients with organ transplant
- Patients with agranulocytosis
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Study site
Beijing
Study site
Changsha
Study site
Chengdu
Study site
Fuzhou
Study site
Guangzhou
Study site
Harbin
Study site
Hengyang
Study site
Jinan
Study site
Nanjing
Study site
Shanghai
Study site
Shaoyang
Study site
Shenyang
Study site
Tianjin
Study site
Xi'an
Study site
Xiamen
About this study
Official title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
- Conditions
- Candidemia, Candidiasis
- Being tested
- Micafungin
- Keywords
- Micafungin, candidiasis, candidemia, Open-label design
- Medical subject headings
- Candidemia, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Intravenous (IV) Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
Measured: up to 8 weeks
Secondary outcomes (1)
Safety assessed by the incidence of adverse events
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start26 Sep 2013
- Primary completion28 Aug 2015
- Study completion28 Aug 2015
Why it stopped: Due to administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Principal investigator, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982071
- Sponsor's protocol ID
- ACN-MA-MYC-IC-2012
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2013
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (CFDA Commitment)
- ClinicalTrials.gov ID
- NCT01982071
- Acronym / sponsor ID
- ACN-MA-MYC-IC-2012
- Conditions
- Candidemia, Candidiasis
- Keywords
- Micafungin, candidiasis, candidemia, Open-label design
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to administrative reasons
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2013 (actual)
- Primary completion
- 28 Aug 2015 (actual)
- Study completion
- 28 Aug 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: MicafunginIntravenous (IV) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
- The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
- The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
Key exclusion criteria (4 listed)
- Patient received any other antifungal drug within 1 month prior to enrollment.
- HIV positive patient
- Patients with organ transplant
- Patients with agranulocytosis
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 |
|---|---|---|
| MicafunginIntravenous (IV) | Drug | Treatment group |
Primary outcome
Overall success rate
Time frame: up to 8 weeks
success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)
1 secondary outcome
Safety assessed by the incidence of adverse events
Time frame: up to 10 weeks
Results and safety
The study was stopped early (reason given: Due to administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 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/.
Related trials for Candidemia
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
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Candidemia
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 principal investigator
Astellas Pharma Inc
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micafungin in people with Candidemia and Candidiasis, run by Astellas Pharma China, Inc. at 15 sites in China.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to administrative reasons). Results are not available in the source record.
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?
Overall success rate (time frame: up to 8 weeks). 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 20 Nov 2024.