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TerminatedNCT01982071Updated Nov 20, 2024

A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

A Phase 4 interventional study of Micafungin in Candidemia and Candidiasis, sponsored by Astellas Pharma China, Inc.. Terminated at 15 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Astellas Pharma China, Inc. (part of Astellas Pharma Inc) · Phase 4, Interventional, and Treatment

Why this study was terminated
Due to administrative reasons
Phase
Phase 4
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Candidemia
  • Candidiasis

Keywords

  • Micafungin
  • candidiasis
  • candidemia
  • Open-label design
03

In context

Candidemia

73 studies on the registry are indexed under Candidemia; 5 are open to participants now.

This study's enrollment of 59 is close to the median of 63 across 44 interventional studies indexed under Candidemia.

Browse Candidemia studies →

Lead sponsor

Astellas Pharma China, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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:

    1. Risk factor (s) of infection
    2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
    3. Two or more positive sputum culture for Candida

Exclusion criteria

Exclusion Criteria:

  • Patient received any other antifungal drug within 1 month prior to enrollment.
  • positive patient
  • Patients with organ transplant
  • Patients with agranulocytosis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Treatment group

    Intravenous (IV)

    Drug: Micafungin

Interventions

06

What researchers measure

Primary outcomes

  1. Overall success rate

    success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment)

    Time frame: up to 8 weeks

Secondary outcomes

  1. Safety assessed by the incidence of adverse events

    Time frame: up to 10 weeks

07

Study locations

15 sites
  • Beijing, China
  • Changsha, China
  • Chengdu, China
  • Fuzhou, China
  • Guangzhou, China
  • Harbin, China
  • Hengyang, China
  • Jinan, China
  • Nanjing, China
  • Shanghai, China
  • Shaoyang, China
  • Shenyang, China
  • Tianjin, China
  • Xi'an, China
  • Xiamen, China
08

References and documents

Individual participant data

Plan to share: 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/.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2013 to primary completion in Aug 2015, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2013
First posted
Nov 13, 2013
StartActual
Sep 26, 2013
Primary completionActual
Aug 28, 2015
CompletionActual
Aug 28, 2015
Last update
Nov 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01982071
Responsible party
Sponsor
First posted
Nov 13, 2013
Start date
Sep 26, 2013
Primary completion
Aug 28, 2015
Completion
Aug 28, 2015
Last update
Nov 20, 2024

Study contacts

Medical Director
principal investigator · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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