None listed
Conditions
Interventions
Group 1 Type of group
MK-0991 70 mg daily dose intravenously, 1 day, followed by 50 mg daily plus placebo for (amphotericin B) injectable liposomal. Treatment duration is 28 days.
Group name:Group 2 Type of group
Amphotericin B liposomal, 3.0 mg / kg daily, plus placebo for MK-0991
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion 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 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Proportion of patients who have a successful treatment outcome. Timepoints:28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Patients will be monitored for adverse experiences throughout the antifungal treatment and in the follow-up of the study. Blood and urine tests will be done in the selection. Measure:Safety Timepoints:Blood and urine tests will be done twice a week during the studys intravenous antifungal therapy, and at the follow-up visit, 2 weeks after the antifungal therapy is complete. ; Outcome name:Clinical Examination Measure:The proportion of patients within each treatment group that survives for 7 days or more after the study medication has ended. Timepoints:7 days ; Outcome name:Absolute white blood cell and neutrophil count Measure:The proportion of patients within each treatment group whose fever resolves during the period of neutropenia. Timepoints:At the pre-study visit, days 4 and 7 of the treatment and the last day of therapy ; Outcome name:Evaluation of signs and symptoms Measure:Proportion of patients within each treatment group with successful treatment of basal fungal infection. Timepoints:The last day of therapy and week 1 and 2 of finishing therapy. ; Outcome name:Evaluation of the signs and symptoms, blood and urine samples for safety (Daily and while the patient receives the study medication will be made white blood cell and absolute neutrophil count) Measure:The proportion of patients within each treatment group with new fungal infections during the administration of the study medication or within 7 days after completing it. Timepoints:Evaluation of signs and symptoms daily and one week after the end of treatment. Samples on days 4, 7 and the last day of treatment. ; Outcome name:Monitoring of adverse events Measure:The proportion of patients within each treatment group who discontinued the study medication due to toxicity related to the study medication or lack of efficacy. Timepoints:Every day of treatment and once a week and two weeks after the end of therapy | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed