Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation
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Purpose
- The primary objective of this study is to evaluate the efficacy and safety profile of itraconazole as in primary prophylaxis
- The second objective of this study is to find the difference between long-term versus short-term sequential therapy of Itraconazole (intravenous followed by oral itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients undergoing allogeneic stem cell transplantation (allo-SCT)
- also to explore the relationship between the incidence of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole
| Condition | Intervention | Phase |
|---|---|---|
|
Hematological Diseases Allogeneic Stem Cell Transplantation |
Drug: itraconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation |
- efficacy evaluation [ Time Frame: 90 days ] [ Designated as safety issue: No ]the success rate of prophylaxis therapy by itraconazole
- group difference evaluation [ Time Frame: 90 days ] [ Designated as safety issue: No ]efficacy difference between long-term and short-term groups per success rate at day 90
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
long-term group
long-term group refers to prophylaxis by using itraconazole for up to 90 days
|
Drug: itraconazole
the two groups are defined by different treatment duration
|
|
short term group
short term group refers to prophylaxis by itraconazole for 30 days
|
Drug: itraconazole
the two groups are defined by different treatment duration
|
Detailed Description:
Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients receiving high dose chemotherapy or allo-SCT. Especially, patients undergoing allo-SCT generally receive intensive immunosuppressive therapy, which make those patients at high risk of developing IFI.
Prompt intensive antifungal therapy may increase the incidence rate of IFI and improved responses and survival. Antifungal prophylaxis has been recommended in patients undergoing allo-SCT by Infectious diseases society of America (IDSA) and Chinese guidelines for the diagnosis and management of IFI in patients with hematologic/malignant tumor (revised).
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 primary antifungal prevention and the course of treatment remain 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 in IFI prophylaxis has been proved by many interventional studies. However the optimal course of prophylaxis is still unknown，especially in China. In this prospective, multicentric study of primary antifungal prevention, long-term or short-term sequential therapy (intravenous followed by oral itraconazole) will be given at standard dose to patients undergoing allogeneic stem cell transplantation to assess the efficacy and safety of itraconazole in primary prophylaxis, and to analysis the relationship between the incidence rate of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole.
Eligibility| Ages Eligible for Study: | 14 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Man or woman between 14 and 60 years of age, inclusive
- Patients who affected by hematological diseases, receiving allo-SCT
- Patients with no previous proven or probable invasive fungal infections. Patients without microbiological evidence but with effective anti-fungal therapy history are inclusive
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
- Currently taking the contra-indicated medications such as teldane, astemizol, cisapride and HMG-CoA reductase inhibitor（e.g. Simvastatin, lovastatin, oral Midazolam and Triazolam）
- History of allergy or intolerance to imidazole or azoles anti-fungal agents (e.g. Fluconazol, Itraconazole, Ketoconazole, Miconazole, Clotrimazole)
- Pregnant women, lactating women or women of child bearing potential without applying valid contraceptive measures
- Patients with current cardiac dysfunction (especially with congestive heart failure) or with the history of congestive heart failure
- Patients with severe liver dysfunction (aminotransferase levels >= 5 times the upper limit of normal and total bilirubin level >= 3mg/dL(51.3 μmol/L); or the severity of liver dysfunction does not match this criteria but the patient is in bad condition and not suitable for this trial( doctors make the decision);
- Patients with renal insufficiency having serum Ccr level <30ml/min, calculated from the following formula:
Male: Ccr (ml/min)=(140-age)×weight (kg) /(0.8136×Crea (μmol/L) ) Female:Ccr (ml/min)=(140-age)×weight (kg) ×0.85/(0.8136× Crea (μmol/L) )
- Patients received any experimental drug within 14 days before the planned start of treatment.
- Patients with bad whole body status and not suitable for the trial (doctors make the decision)
Contacts and Locations| Contact: Yonghua Li, MD | 8613751880527 | lyhood@163.com |
| Contact: Xiaohui Zeng, Pharm D | 8613560327666 | gzlcyljd@163.com |
| China, Guangdong | |
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting |
| Guangzhou, Guangdong, China, 510010 | |
| Contact: Yonghua Li, MD 8613751880527 lyhood@163.com | |
| Contact: Xiaohui Zeng, Pharm D 8613560327666 gzlcyljd@163.com | |
| Principal Investigator: Yang Xiao, MD | |
| Principal Investigator: | Yang Xiao, MD | Guangzhou General Hospital of Guangzhou Military Command |
More Information
Publications:
| Responsible Party: | Jian Liu (President of the hospital), Guangzhou General Hospital of Guangzhou Military Command |
| ClinicalTrials.gov Identifier: | NCT01160952 History of Changes |
| Other Study ID Numbers: | SPO-I-08-CN-041-C, ITRFUN4046 |
| Study First Received: | July 12, 2010 |
| Last Updated: | July 23, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Guangzhou General Hospital of Guangzhou Military Command:
|
primary prophylaxis itraconazole stem cell transplantation |
Additional relevant MeSH terms:
|
Hematologic Diseases Itraconazole Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013