Daptomycin in treating patients with cancer having low blood count with fever due to known or suspected serious bacterial infections

Phase 4

• Conditions: Health Condition 1: null- Adult hemat-oncology neutropenic patients with fever.

• Registration Number: CTRI/2013/03/003477
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 100

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

�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

oExpected 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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified