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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00003938 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients
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Scientific title:
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A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials |
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Date of first enrolment:
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June 1999 |
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Target sample size:
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115 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00003938 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Primary Purpose: Supportive Care
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Countries of recruitment
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Belgium
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Czech Republic
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France
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Germany
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Greece
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Hungary
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Israel
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Italy
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Netherlands
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Portugal
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Slovakia
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Spain
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Sweden
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Turkey
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United Arab Emirates
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Contacts
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Name:
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P. Ljungman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska University Hospital, Huddinge |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Hematologic malignancy or solid tumor
- Must be undergoing remission induction and/or consolidation therapy for hematologic
malignancy only OR
- Must be undergoing allogeneic or autologous bone marrow transplantation
- Granulocyte count less than 500/mm^3 and profound granulocytopenia expected to last
for greater than 5 days
- Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less
than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial,
fungal, viral, parasitic, and mycobacterial infections
- Peripheral blood cultures and central venous catheter cultures negative for
infections
- No microbiological documentation of a bacterial infection (e.g., abscess at catheter
site)
- No invasive fungal infection
- No probable noninfectious cause of fever
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 40-100% OR
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No prior anaphylactic reaction to amphotericin B
- No psychological, familial, sociological, or geographical conditions that would
prevent compliance
- Not pregnant or nursing
- Normal chest X-ray or normal high resolution CT scan of the lungs
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g.,
azoles or polyenes)
- No prior IV amphotericin B during same neutropenic episode
- No change in antibacterial regimen within 48 hours prior to study
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Drug: liposomal amphotericin B
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Secondary ID(s)
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EORTC-19951
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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