Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine

Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine - Usefulness of micafungin in the empiric therapy of invasive fungal infections in surgery and intensive-care medicine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011388

Enrollment

Registered

2013-08-07

Start date

2013-06-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing gastroenterological surgery

Interventions

1. Patients with a proven or probable invasive fungal infections Micafungin, 150 mg (dissolved in saline) per day, is administered as a more than 1-hour infusion. Initial assessment is done on the 1

s symptoms and the physical examination findings, is insufficient within 14 days, the dose increase or change to other drug at a physician&#39

s discretion is permitted. Micafungin (300 mg) is administered to the patients with funduscopic finding. 2. Patients with a possible invasive fungal infections Micafungin, 100 mg (dissolved in salin

s symptoms and the physical examination findings, is insufficient within 7 days, the dose increase or change to other drug at a physician&#39

s discretion is permitted.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with a diagnosis of invasive fungal infections among febrile patients unresponsive to broad-spectrum antibiotics with several risk factors. 1.High APACHIII score 2.ICU length of stay: more than 7 days 3.Mechanical ventilator: more than 48 hours 4.Patients with renal dysfunction or on dialysis 5.Severe acute pancreatitis, diabetes 6.Perforation of the upper gastrointestinal tract 7.IVH indwelling line, high-calorie infusion 8.Steroid administration: more than 3 weeks 9.Within 30 days after the last immunosuppressant therapy 10.Other serious disease complication 2.Patients with a proven or probable invasive fungal infections Patients for whom Candida species are detected at blood, tip of a central venous catheter, puncture of abscess or sterile site, or for whom fungal endophthalmitis is observed in funduscopic finding. 3.Patients with a possible invasive fungal infections Patients with a possible invasive fungal infections for whom beta-D-glucan is positive or the colonization Candida species is detected in surveillance culture.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of drug allergy against micafungin. 2. Patients with severe hepatic dysfunction. (bilirubin concentrations three times or ALT or AST five times the upper limit of the normal reference range)

Design outcomes

Primary

Measure	Time frame
1. The efficacy of micafungin in patients with a proven or probable invasive fungal infection is evaluated on the 14th day (initial assessment) and at the end of dosing (final assessment). 2. The efficacy of micafungin in patients with a possible invasive fungal infection is evaluated on the 7th day (initial assessment) and at the end of dosing (final assessment).	—

Secondary

Measure	Time frame
1. Persistence rate of micafungin administration 2. Adverse event during micafungin administration and follow-up 3. Mortality rate during micafungin administration 4.Susceptibility of isolated Candida spp.	—

Countries

Japan

Contacts

Public ContactHiroki Ohge

Hiroshima University Hospital Department of infectious disease

ohge@hiroshima-u.ac.jp082-257-1613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026