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
- Conditions
- -R509 Fever, unspecifiedFever, unspecifiedR509
- Registration Number
- PER-020-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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.
• the patient is not expected to survive at least 5 days.
• The patient is pregnant or breast-feeding.
• The patient has a diagnosis of hepatitis or acute cirrhosis due to any cause.
• The patient participated or is participating in any other clinical study that includes the administration of a drug under investigation, with the exception of antineoplastic agents, within 14 days prior to entering the study, or during the course of the study. The use of antineoplastic agents under investigation is only prohibited during the course of the study therapy.
• The patient participated in this study at any other time.
• The patient presents any concomitant condition or disease that, in the opinion of the investigator, could confuse the results of the study, or pose an additional risk in the administration of study drugs.
• The patient receives rifampin, cyclosporin A. or concomitant systemic antifungal therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A treatment is defined as successful if it meets the following 5 criteria: 1) survival for 7 days after completing treatment with the study drug, 2) resolution of fever during the period of neutropenia, 3) successful treatment of any infection fungal infection, if present, 4) absence of new fungal infections during the administration of the study medication, or within 7 days after the end of treatment, and 5) absence of premature discontinuation of study medication due to drug-related toxicity or lack of efficacy.<br>Measure:Proportion of patients who have a successful treatment outcome.<br>Timepoints:28 days<br>
- Secondary Outcome Measures
Name Time Method