To Determine Whether Galactomannan Test Will Help to Detect Fungal Infections Early and Hence Start Treatment Early

NCT00361517 | Completed Phase 3 DMC

• 2 other identifiers: NMRC/0984/2005IRB #291/2005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aspergillosis

Keywords

GM monitoring; Immunocompromised; hematological disorder; Allogenic HSCT recipients; Aspergillus PCR assay

Outcome Measures

Primary Outcomes (1)

• Development of proven or probable invasive fungal infection, fungal related mortality and overall survival in an intention to treat basis.

  During neutropenia, or, in HSCT patients, while under immunosuppressive therapy

Secondary Outcomes (1)

• Duration of antifungal therapy and toxicity associated with antifungal therapy.

  while patient is on follow-up.

Study Arms (2)

GM test

EXPERIMENTAL

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; Other: blood draws; Other: blood draws for GM monitoring; Drug: Amphotericin-B deoxycholate; Other: blood test

no GM monitoring

NO INTERVENTION

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.

Interventions

Galactomannan antigen monitoring, Aspergillus PCR BEHAVIORAL

There will be blood draws twice weekly for monitoring GM antigen and once a week for Aspergillus PCR.

GM test

blood draws OTHER

Blood is drawn for monitoring of Galactomannan antigen in the blood

GM test

blood draws for GM monitoring OTHER

blood samples will be taken twice weekly for monitoring of GM antigen levels in the blood and once a week for Aspergillus PCR.

GM test

Amphotericin-B deoxycholate DRUG

1-1.5mg/kg, i.v, once a day

Also known as: Fungizone, Abelcet, AmBisome, Fungisome, Amphocil,

GM test

Blood test OTHER

Blood will be tested twice a week for the presence of Galactomannan.

GM test

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead
• National University Hospital, Singapore: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (2)

• 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.

  PMID: 11170942 BACKGROUND

• 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.

  PMID: 21397541 DERIVED

MeSH Terms

Conditions

Aspergillosis; Hematologic Diseases

Interventions

Blood Specimen Collection; amphotericin B, deoxycholate drug combination; Amphotericin B; liposomal amphotericin B; Hematologic Tests

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Ban H Tan, Dr

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2006
• First Posted: August 8, 2006
• Study Start: June 1, 2006
• Primary Completion: October 30, 2007
• Study Completion: June 30, 2009
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

SG (1)