CTRI/2013/03/003477
Recruiting
Phase 4
An exploratory, observational study to evaluate the efficacy and safety of daptomycin in treating neutropenic patients with fever due to known or suspected gram positive infections in adult hemato-oncology patients.
ovartis Healthcare Pvt Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •oTemperature 38\.3 degrees C once OR greater than or equal to 38 degrees C twice within 12 hours
- •oAbsolute neutrophil count 500/cubic mm and greater than or equal to 1 of the following:
- •ï?§Mucositis
- •ï?§Concurrent skin or soft tissue infection
- •ï?§Indwelling catheter and/or suspected catheter infection
- •ï?§Recent quinolone prophylaxis
- •ï?§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)
- •ï?§Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise
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
Outcomes
Primary Outcomes
Not specified
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