None listed
Conditions
Interventions
Group 1 Type of group
linezolid 600 mg IV every 12 hours for 28 days
Group name:Group 2 Type of group
vancomycin 1 g IV every 12 hours (dose can be adjusted according to renal function) for 28 days
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female subject of at least 13 years of age and weighing at least 40 kg. • Be in a feverish state. It is not allowed to take the temperature in tympanic / auricular or axillary form. • Present neutropenia or expect neutropenia to occur within 48 hours, defined as an absolute neutrophil count (ANO) <500 cells / mm3. • Have an oncological / hematological malignancy (including solid tumor, lymphoma or leukemia) whereby at least one chemotherapy agent known to induce neutropenia has been administered in a consistent manner. • Present an alleged gram-positive infection • Present will and be able to complete all activities related to the study and the follow-up visit. • Be able to receive, during the study, 300 ml of fluid volume intravenously, for 60 minutes and every 12 hours.
Exclusion criteria
Exclusion criteria: • Women with fertile potential who are unable to take adequate contraception precautions, who have a positive pregnancy test result within 24 hours before entering the study, or who are known to be pregnant or breast-feeding a baby in the present. • Current episode of fever clearly associated with the administration of substances known as pyrogens (for example, phlegmatic components, transfusions, hematopoietic growth factors, interferon alpha or other cytokines). This criterion does not necessarily exclude the use of these types of treatment, it only applies if they are associated with fever. • Identification of a specific pathogen responsible for the fever prior to entering the study. • Fever in patients who have convincing evidence of a noninfectious source of fever (eg, deep vein thrombosis or drug fever). • Neutropenia associated with syndromes unrelated to a high risk of bacterial infection (eg, benign chronic neutropenia). • Infection with the human immunodeficiency virus (HIV). • Improbability to survive during the treatment period and follow-up evaluation (7 to 14 days after treatment). • Bone marrow transplant within 4 weeks before entering the study. • Patients in whom it is believed that an intravenous catheter is the origin of the infection and whose line will not be removed within 48 hours after the start of the study medication. • Administration for more than 24 hours of a potentially effective antibiotic treatment within 72 hours prior to entering the study, in the presence of clinical improvement. In the absence of clinical improvement, patients can be randomized to the study without any washing interval. Patients receiving antibiotics as prophylaxis are not excluded from the study. In randomization patients will be stratified according to the use of prophylactic antibiotics. • Patients with suspected or documented active systemic viral infections or fungal infections requiring intravenous therapy (patients receiving antifungals or oral antivirals or topical baseline are eligible to enter the study). • Endocarditis, meningitis, osteomyelitis, or infections of the central nervous system (CNS). If their existence is assumed, these diagnoses must be excluded before incorporating the patient into the study. • Uncontrolled or untreated hypertension. • Pheochromocytoma, carcinoid syndrome, or untreated hyperthyroidism, known. • Cystic fibrosis, or patients with known or suspected active tuberculosis. • Empyema or pulmonary abscess without draining. • Decubitus and ischemic ulcers, necrotizing fasciitis, gas gangrene, or burns that cover more than 20% of the total body surface area. • Have previously entered this protocol or another linezolid protocol. • Hypersensitivity to linezolid or vancomycin or to any of its excipients. • Concurrent use of another medication under investigation, or its use within 30 days of entering the study (for the purposes of this study, under investigation is defined as a medication that has not been approved to be used at least for an indication ). This criterion does not exclude patients receiving regimens under investigation of approved chemotherapeutic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Obtained from the Clinical Result of the Investigator registered in the CRF, with a conservative review evaluated by the Sponsor Measure:Clinical Outcome Defined by the Sponsor Timepoints:After the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Microbiological Outcome of the Patient Defined by the Sponsor Measure:Microbiological Outcome Timepoints:At the end of the study ; Outcome name:Rates of eradication of individual pathogens Measure:Eradication of the pathogen Timepoints:After treatment ; Outcome name:Defined as a Tmax 500 cells / mm3. Measure:Resolution of neutropenia Timepoints:After treatment ; Outcome name:Time elapsed until the resolution of neutropenia. Measure:Time elapsed until the resolution of neutropenia. Timepoints:Time after the treatment ; Outcome name:Survival 7 days after the end of therapy. Measure:Mortality rate Timepoints:7 days | — |
Outcome results
None listed