Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection
|ClinicalTrials.gov Identifier: NCT01198236|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : October 14, 2011
Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients with a history of invasive fungal infection (IFI) are at high risk of developing relapse and fatal complications.
Prompt intensive antifungal therapy, have improved responses and survival, allowing an increase of antifungal treatments, including secondary antifungal prophylaxis.
Few studies have addressed the role of previous IFI in the feasibility of stem cell transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of infection after transplantation. However, given the lack of prospective studies, the role of secondary antifungal prophylaxis remains unclear.
Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans, non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides, Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma spp. and various kinds of yeast fungi and mycetes.
The role of itraconazole IFI prophylaxis treatment has been proved by many interventional studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will be given at standard dose to patients undergoing allogeneic stem cell transplantation or chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of itraconazole secondary prophylaxis.
|Condition or disease||Intervention/treatment||Phase|
|Invasive Fungal Infection||Drug: Itraconazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||November 2010|
Itraconazole will be administered intravenously 2×200 mg/d(200mg twice a day, with 12 hours interval, and should be completed in no less than 60 minutes each time) in the first two days of treatment as a loading dose, then 200mg/d intravenously (200mg once a day with 24 hours interval and completed in no less than 60 minutes) until the end of the at-risk period.
In transplant patients, the end of "at-risk period" is defined as a stable engraftment of 1*109/L neutrophil cells; in patients who have undergone chemotherapy, it is defined as the resolution of neutropenia (neutrophil cells> 0.5*109/L).
If needed, the patients will take itraconazole solution orally after intravenous administration.
- successful prophylaxis rate [ Time Frame: more than 7 days ]The rate of patients without documented relapse of the fungal infection and the absence of new proven, probable or possible IFI at the end of secondary prophylaxis treatment and 7 days later.
- rate of patients who developed persistent fever or pulmonary infiltrates of unknown etiology [ Time Frame: at least 7 days ]The rate of patients who developed persistent fever or pulmonary infiltrates of unknown etiology. For those neutropenic patients with persistent fever, antibiotics should be used according to the International anti-infection guideline in order to exclude the possibility of bacterial infection. If the fever persists after 5-6 days' combination use of itraconazole and antibiotics, this case would be regarded as "secondary prophylaxis failure" and the trial is terminated , while doctors should search for further clinical therapy to save the patient.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198236
|The First Hospital of Zhejiang Medical Colleage Zhejiang University|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||He Huang, MD||The First Hopspital of Zhejiang Medical Colleage, Zhejiang University|