Invasive Fungal InfectionsNCT02678598
A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
An observational study of Invasive Fungal Infections, run by Astellas Pharma China, Inc. at 17 sites in China.
Trial summary
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infections
- What is being tested?
- Micafungin
- Type of treatment
- Injection or infusion
- How many people
- 2,555 participants
- Where
- 17 sitesChina
- Study dates
- Mar 2015to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The hospitalized patients who received intravenous micafungin for treatment according to the clinical judgment of the treating physician before the end of April 2015
Who may be able to join
- Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy
- Patients received Micafungin treatment at least 1 dose
Who cannot join
- Patients received Micafungin treatment combined with other antifungal drugs at the same time
- Neither efficacy or safety can be evaluated because of missing data, confused record
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Study site
Beijing
Study site
Changchun
Study site
Chengdu
Study site
Chongqing
Study site
Fuzhou
Study site
Guangzhou
Study site
Guizhou
Study site
Haikou
Study site
Hangzhou
Study site
Harbin
Study site
Hengyang
Study site
Langfang
Study site
Shanghai
Study site
Shijiazhuang
Study site
Wuhan
Study site
Xiamen
Study site
Zhengzhou
About this study
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
- Conditions
- Invasive Fungal Infections
- Being tested
- Micafungin
- Keywords
- Micafungin, Candida, Aspergillosis, Antifungal
- Medical subject headings
- Invasive Fungal Infections, Torulopsis, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicafunginDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Micafungin group | Not described Receives: Drug: Micafungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success rate
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%
Measured: Up to 12 months
Secondary outcomes (2)
Overall incidence and severity of adverse events
Measured: Up to 12 months
Overall incidence and severity of adverse drug reactions
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678598
- Sponsor's protocol ID
- 9463-MA-3003
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zheng X, Huang X, Luo J, Li J, Li W, Liu Q, Niu T, Wang X, Zhou J, Zhang X, Hu J, Liu K. Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study. Adv Ther. 2018 Sep;35(9):1400-1410. doi: 10.1007/s12325-018-0762-5. Epub 2018 Aug 13.
PubMed 30105657
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections
- ClinicalTrials.gov ID
- NCT02678598
- Acronym / sponsor ID
- 9463-MA-3003
- Conditions
- Invasive Fungal Infections
- Keywords
- Micafungin, Candida, Aspergillosis, Antifungal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,555 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Feb 2016 (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.
The objective of this study is to evaluate the efficacy of intravenous micafungin for the empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy patients with invasive fungal infections caused by Candida sp. or Aspergillus sp. (fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micafungin group | – | Drug: Micafungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The hospitalized patients who received intravenous micafungin for treatment according to the clinical judgment of the treating physician before the end of April 2015
Key inclusion criteria (2 listed)
- Patients who received Micafungin as empirical antifungal therapy, pre-emptive antifungal therapy, diagnostic driven antifungal therapy or targeted antifungal therapy
- Patients received Micafungin treatment at least 1 dose
Key exclusion criteria (2 listed)
- Patients received Micafungin treatment combined with other antifungal drugs at the same time
- Neither efficacy or safety can be evaluated because of missing data, confused record
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 | Drug | Micafungin group |
Primary outcome
Overall success rate
Time frame: Up to 12 months
Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100%
2 secondary outcomes
Overall incidence and severity of adverse events
Time frame: Up to 12 months
Overall incidence and severity of adverse drug reactions
Time frame: Up to 12 months
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 10 Feb 2016.
- Derived from this study: PubMed 30105657Zheng X, Huang X, Luo J, Li J, Li W, Liu Q, Niu T, Wang X, Zhou J, Zhang X, Hu J, Liu K. Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study. Adv Ther. 2018 Sep;35(9):1400-1410. doi: 10.1007/s12325-018-0762-5. Epub 2018 Aug 13.
- Individual participant dataSharing planned: Undecided
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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 China, Inc.
17 sites in 1 country: 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 China, Inc. at 17 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 2 inclusion and 2 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
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?
Overall success rate (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678598, which also lists 1 linked publication.
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 10 Feb 2016.