PER-020-00
Completed
未知
A MULTICENTRIC, DOUBLE-BLIND, COMPARATIVE, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF MK-0991 COMPARED WITH (ANFOTERICIN B) LIPOSOMAL INJECTABLE AS EMPIRICAL THERAPY IN PATIENTS WITH PERSISTENT FEVER AND NEUTROPENIA
MERCK SHARP & DOHME PERU S.R.L.,0 sites0 target enrollmentMarch 24, 2000
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -R509 Fever, unspecified
- Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient receives chemotherapy because of leukemia, lymphoma or other cancers, or underwent a bone marrow or peripheral blood stem cell transplant.
- •Has an absolute neutrophil count \<250 / mm ^, has fever that does not resolve within 120 hours (resolution of fever is defined as \<38\.0 ° C for 48 consecutive hours), while receiving antibacterial therapy empirical Fever is defined as oral temperature\> 38\.3 ° C (or core temperature\> 38\.0 ´´ C) on one occasion, or\> 38\.0 ° C on two or more occasions during a 12\-hour period.
- •The patient is at least 16 years old (female or male).
- •For women of childbearing age, the patient has a negative pregnancy analysis in serum or urine, sensitive to 25 IU of HCG, prior to entering the study, and subsequently uses birth control measures defined as adequate by the researcher. Oral contraceptives should not be used as the only method of birth control, because the effect of MK\-0991 on the effectiveness of such contraceptives has not yet been established.
Exclusion Criteria
- •At the time of admission, the patient has a bacterial infection that has been handled improperly.
- •At the time of admission, the patient has a documented invasive fungal infection.
- •The patient shows abnormal laboratory values:
- •o Platelet count \<5000 / p\-l.
- •or NIR\> 1\.6 (if the patient receives anticoagulants, INR\> 4\.0\)
- •or Bilirubin\> 3 times the upper limit of normal.
- •or AST (SGOT) or ALT (SGPT)\> 5 times the normal upper limit.
- •or alkaline phosphatase\> 3 times the upper limit of normal.
- •The patient has a history of allergy, hypersensitivity, or any serious reaction to the echinocandin antifungal or an amphotericin B formulation.
- •The patient received any form of parenteral amphotericin B within 10 days prior to the administration of the study medication.
Outcomes
Primary Outcomes
Not specified
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