Skip to content

A prospective, multicenter, single-arm study to evaluate the safety and efficacy of micafungin for prophylaxis of invasive fungal infection in high risk hematological patients

A prospective, multicenter, single-arm study to evaluate the safety and efficacy of micafungin for prophylaxis of invasive fungal infection in high risk hematological patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PNC-11001575
Enrollment
Unknown
Registered
2011-09-20
Start date
2011-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Invasive Fungal Infections

Interventions

1:Mycamine ( Micafungin Sodium for injection) should be administered 50mg/day, Intravenous infusion, and should be taken on the first day of the transplantation/ chemotherapy, with administration peri

Sponsors

Shanghai First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 ~ 60 of either gender; 2. patients with malignant haematological disease undergoing a hematopoietic stem cell transplant or chemotherapy; 3. patient with high-risk of IFI: patient with anticipated neutropenia (absolute neutrophil count [ANC] <500 cells/mm3 )for 7 days or profound neutropenia (absolute neutrophil count [ANC] <100 cells/mm3) even application of G-CSF is also considered; 4. Patients with no history of IFI and antifungal prophylaxis; 5. Given written informed consent.

Exclusion criteria

Exclusion criteria: 1. G test positive at screening; 2. Diagnosed as IFI (including possible, probable or proven) before enrollment; 3. Pregnant woman or breast-feeding mother; 4. Elevated AST/SGOT or ALT/SGPT >5 times ULN; 5. Total bilirubin >2.5 times ULN; 6. Known allergy to echinocandin; 7. Other patients with complications who are unsuitable to be included in the trial judged by investigator; 8. Patients who is participating in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Treatment successful rate at the end of treatment;

Secondary

MeasureTime frame
The incidence of possible invasive fungal infection;The incidence of proven or probable invasive fung;

Countries

China

Contacts

Public ContactChun. Wang
wangchun2@medmail.com.cn+86 13386259777

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026