Health Condition 1: null- Adult hemat-oncology neutropenic patients with fever.
Conditions
Interventions
Intervention1: Daptomycin: Cubicin is indicated for the treatment of the infections listed below:
Complicated skin and skin structure infections caused by Gram-positive susceptible isolates.
Daptomy
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either gender, above the age of 18 years, who have received atleast 1 dose on daptomycin 2. Hemato-Oncology patients with diagnosis of neutropenic fever o Temperature 38.3 degrees C once OR greater than or equal to 38 degrees C twice within 12 hours o Absolute neutrophil count 500/cubic mm and greater than or equal to 1 of the following: � Mucositis � Concurrent skin or soft tissue infection � Indwelling catheter and/or suspected catheter infection � Recent quinolone prophylaxis � Positive blood cultures for gram-positive cocci before final identification Known Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin) � Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise o Expected duration of neutropenia greater than or equal to 3 days 3. Have a life expectancy of greater than or equal to 2 weeks. 4. Have performance status with an Eastern Cooperative Oncology Group score of less than or equal to 2. 5. Creatinine clearance greater than or equal to 30 mL/min 6. Negative pregnancy test [Note : Fertile patients must use effective double-method contraception] 7. No psychiatric disorders that would preclude study compliance, No HIV positivity. 8. No suspected meningitis or osteomyelitis. 9. No documented or suspected gram-positive pneumonia 10. No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation 1,000 U/L (5 times upper limit of normal [ULN]) [No CPK elevations 10 times ULN in patients with no signs or symptoms of myopathy] 11. No known sensitivity to daptomycin or product excipients 12. Patient is willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Known allergic reaction to daptomycin or product excipients 2. Known to be infected with a daptomycin-resistant organism or a gram-negative organism and did not yet meet the criteria for the addition of antimicrobial therapy for the treatment of an infection caused by a gram-positive organism; 3. Suspected meningitis or osteomyelitis 4. Currently pregnant, were positive for serum human chorionic gonadotropin, or lactating 5. Have a creatinine clearance (CLCR) level of 30 ml per min; or on hemodialysis or continuous ambulatory peritoneal dialysis; 6. Psychiatric disorders with an inability to comply with study protocols; 7. Documented or suspected pneumonia caused by a gram-positive organism; 8. Life expectancy of 2 weeks; 9. Have rhabdomyolysis or a history of rhabdomyolysis or have signs and symptoms of myopathy with an elevation of the creatine phosphokinase (CPK) level of 1,000 U per liter (approximately five times the upper limit of normal); or reported signs or symptoms of myopathy and elevations of the CPK level of 10 times the upper limit of normal 10. Diabetic patient taking concurrent medication Piglitazone 11. No concurrent hydroxymethyl glutaryl coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin) 12. Hemoglobulin levels below 7gm per dl. 13. Patient unable or unwilling to follow or comply with all study-related procedures 14. Patient participating in another clinical study requiring follow-up examinations 15. Patients, who in the opinion of the Investigator is not suitable for this study regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of daptomycin in treating neutropenic patients with fever due to known or suspected gram positive infections in hemato-oncology patients in terms of the : Clinical Response to therapy. Timepoint: At 72 hours and End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the mean time to clinical improvement -Resolution of patient signs and symptoms (eg. time to afebrile state with or without neutropenia, etc) or other evidence of infection, including cultures, which responded while on daptomycin therapy. -To determine the incidence of breakthrough infections that requires a change of therapy or additional agents to clear. -To evaluate safety of daptomycin treatment (in terms of number of adverse events)Timepoint: During and end of treatment. | — |
Countries
India
Contacts
Public ContactDr Sameer Guliani
Novartis India Limited
Outcome results
None listed