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

NCT ID: NCT01501708

Last Updated: 2016-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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

Conditions

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Leukemia Transplantation, Hematopoietic Stem Cell

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caspofugin based combination therapy

Caspofugin based combination therapy:

Patients will recieve caspofungin with voriconazole or amphotericin B

Group Type EXPERIMENTAL

Caspofugin based combination therapy

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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caspofungin + voriconazole or amphotericin B

Eligibility Criteria

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Inclusion Criteria

* adult patient undergoing allogeneic hematopoietic stem cell transplantation
* age 18-55 years
* with inform consent
* no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
* HLA mismatched related (3\~5/6) or unrelated donors (at least 8/10)
* proven or probable IFI

Exclusion Criteria

* age less than 18 years or over 56 years
* HLA mismatched related donor
* liver function/renal function damage (over 2 X upper normal range)
* with mental disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jiong HU

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rui Jin Hospital, Shanghai JiaoTong University School of Medicine

Locations

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Blood & Marrow Transplantation Center, RuiJin Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiong HU, M.D.

Role: CONTACT

86-21-64370045 ext. 601818

Facility Contacts

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Ling Wang, M.D

Role: primary

86-21-64370045 ext. 601818

Other Identifiers

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RJH-2011-71

Identifier Type: -

Identifier Source: org_study_id

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