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| Sponsor: | Singapore General Hospital |
|---|---|
| Collaborator: |
National University Hospital, Singapore |
| Information provided by: | Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00361517 |
Purpose
Chemotherapy lowers the white blood cell count or weakens the immune system for a long time. This puts the patients at a high risk of getting a serious fungal infection of the internal organs or blood. One of these infections is caused by a mold called Aspergillus and can be life threatening. Usually doctors give preventive antifungal therapy to try to lower the risk of this infection. Despite this, patients are still at risk of getting fungal infection. This study is thus designed to test Galactomannan - a component of cell wall of Aspergillus and hence detect and treat fungal infection early.
| Condition | Intervention | Phase |
|---|---|---|
|
Aspergillosis |
Behavioral: Galactomannan antigen monitoring, Aspergillus PCR Other: blood draws Other: blood draws for GM monitoring Drug: Amphotericin-B deoxycholate Other: blood test Other: Blood test |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Using Serum Galactomannan Levels in a Prospective, Randomised, Non-Blinded Trial to Guide Early Anti-Fungal Therapy in Haematology Patients at Risk of Invasive Aspergillosis. |
| Enrollment: | 47 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | June 2009 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GM test
Twice weekly blood draws from the patients in this arm for serial GM monitoring. They will be given standard antifungal prophylaxis but no antifungal therapy unless two consecutive GM readings are positive.
|
Behavioral: Galactomannan antigen monitoring, Aspergillus PCR
There will be blood draws twice weekly for monitoring GM antigen and once a week for Aspergillus PCR.
Other: blood draws
Blood is drawn for monitoring of Galactomannan antigen in the blood
Other: blood draws for GM monitoring
blood samples will be taken twice weekly for monitoring of GM antigen levels in the blood and once a week for Aspergillus PCR.
Drug: Amphotericin-B deoxycholate
1-1.5mg/kg, i.v, once a day
Other Name: Fungizone, Abelcet, AmBisome, Fungisome, Amphocil,
Other: blood test
Blood will be tested twice a week for the presence of Galactomannan.
Other: Blood test
Blood will be drawn twice a week and it will be tested for the presence of GM(a component of the cell wall of the mold Aspergillus which is released during growth)
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|
No Intervention: no GM monitoring
in this arm the patients will not have any GM monitoring and they will be given standard antifungal prophylaxis and treatment according to the published guidelines.
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The diagnosis of invasive Aspergillosis (IA) remains a challenge in the febrile neutropenic and the hematopoietic stem cell transplant (HSCT) recipients. Recent studies have shown that early diagnosis of IA is possible in this group of high-risk patients. Serial screening of circulating Galactomannan (GM), an epitopic determinant of several antigens secreted by the Aspergillus early in its growth, has been shown to be sensitive and specific in the diagnosis of IA. This test may help us to detect IA early, thereby permitting a pre-emptive strategy to be initiated in high-risk patients. In a prospective, randomized, non-blinded study, we seek to compare the outcome of a novel GM-guided anti-fungal strategy against the conventional empirical antifungal therapy. Patients randomized to the conventional arm will not undergo serial GM monitoring, but will receive standard anti-fungal prophylaxis and standard empirical antifungal therapy in accordance with published guidelines. Patients randomized to the GM arm will receive standard anti-fungal prophylaxis but will not receive empiric anti-fungal therapy unless 2 GM readings are positive. The study aims to determine if such a strategy permits targeted, pre-emptive therapy in those at greatest risk, and spare febrile patients without evidence of fungal infection other than prolonged fever from unnecessary and potentially toxic therapy. It also aims to determine if GM guided pre-emptive antifungal therapy using Amphotericin-B deoxycholate prevents the development of proven or probable invasive aspergillosis (IA). The study will also prospectively evaluate (in a blinded fashion) the use of realtime polymerase chain reaction (RT PCR) assay in the same cohort of patients receiving GM serial monitoring, and investigate its role in the diagnosis and treatment monitoring of invasive Aspergillosis.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Singapore | |
| Singapore General Hospital | |
| Singapore, Singapore, 169608 | |
| Principal Investigator: | Ban H Tan, Dr | Singapore General Hospital |
More Information
| Responsible Party: | Dr Tan Ban Hock, Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00361517 History of Changes |
| Other Study ID Numbers: | NMRC/0984/2005, IRB #291/2005 |
| Study First Received: | August 6, 2006 |
| Last Updated: | June 23, 2009 |
| Health Authority: | Singapore: Health Sciences Authority |
|
GM monitoring Immunocompromised hematological disorder Allogenic HSCT recipients Aspergillus PCR assay |
|
Aspergillosis Mycoses Amphotericin B Liposomal amphotericin B Antifungal Agents Amphotericin B, deoxycholate drug combination Deoxycholic Acid Amebicides |
Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents Cholagogues and Choleretics Gastrointestinal Agents |
