- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361517
To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early
September 24, 2018 updated by: Singapore General Hospital
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.
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Singapore, Singapore, 169608
- Singapore General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days
- Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days
- Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin
- Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens
- Patients are at least 12 years of age, with Karnofsky score of 70%.?
- Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days
Exclusion Criteria:
- Patients who are human immunodeficiency virus (HIV) infected
- Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation
- Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10].
- Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid
- Patients on palliative chemotherapy
- Patients with history of allergy to triazoles
- Patients with prior history of anaphylactic reaction to conventional amphotericin B
- Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min
- Patients with expected life-expectancy < 72 hours
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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There will be blood draws twice weekly for monitoring GM antigen and once a week for Aspergillus PCR.
Blood is drawn for monitoring of Galactomannan antigen in the blood
blood samples will be taken twice weekly for monitoring of GM antigen levels in the blood and once a week for Aspergillus PCR.
1-1.5mg/kg, i.v, once a day
Other Names:
Blood will be tested twice a week for the presence of Galactomannan.
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of proven or probable invasive fungal infection, fungal related mortality and overall survival in an intention to treat basis.
Time Frame: During neutropenia, or, in HSCT patients, while under immunosuppressive therapy
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During neutropenia, or, in HSCT patients, while under immunosuppressive therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of antifungal therapy and toxicity associated with antifungal therapy.
Time Frame: while patient is on follow-up.
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while patient is on follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ban H Tan, Dr, Singapore General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lin SJ, Schranz J, Teutsch SM. Aspergillosis case-fatality rate: systematic review of the literature. Clin Infect Dis. 2001 Feb 1;32(3):358-66. doi: 10.1086/318483. Epub 2001 Jan 26.
- Tan BH, Low JG, Chlebicka NL, Kurup A, Cheah FK, Lin RT, Goh YT, Wong GC. Galactomannan-guided preemptive vs. empirical antifungals in the persistently febrile neutropenic patient: a prospective randomized study. Int J Infect Dis. 2011 May;15(5):e350-6. doi: 10.1016/j.ijid.2011.01.011. Epub 2011 Mar 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
October 30, 2007
Study Completion (Actual)
June 30, 2009
Study Registration Dates
First Submitted
August 6, 2006
First Submitted That Met QC Criteria
August 6, 2006
First Posted (Estimate)
August 8, 2006
Study Record Updates
Last Update Posted (Actual)
September 26, 2018
Last Update Submitted That Met QC Criteria
September 24, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Aspergillosis
- Anti-Infective Agents
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Amebicides
- Cholagogues and Choleretics
- Deoxycholic Acid
- Amphotericin B
- Liposomal amphotericin B
- Amphotericin B, deoxycholate drug combination
Other Study ID Numbers
- NMRC/0984/2005
- IRB #291/2005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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