NCT01501708

Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection

Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.

Detailed description

Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection

Conditions

• Leukemia
• Transplantation, Hematopoietic Stem Cell

Interventions

Type	Name	Description
DRUG	Caspofugin based combination therapy	Caspofungin: 70 mg on the first day of therapy, followed by 50 mg q.d. * All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given. * In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given.

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2011-12-29
• Last updated: 2016-05-10

Locations

1 site across 1 country: China