To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00361517|
Recruitment Status : Completed
First Posted : August 8, 2006
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||June 1, 2006|
|Actual Primary Completion Date :||October 30, 2007|
|Actual Study Completion Date :||June 30, 2009|
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)
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.
- 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 ]
- Duration of antifungal therapy and toxicity associated with antifungal therapy. [ Time Frame: while patient is on follow-up. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361517
|Singapore General Hospital|
|Singapore, Singapore, 169608|
|Principal Investigator:||Ban H Tan, Dr||Singapore General Hospital|