To evaluate the efficacy and safety of daptomycin in treatment of gram positive bacterial infection in adults with end stage renal disease on dialysis.

Phase 4

• Conditions: Health Condition 1: null- gram positive bacteremia

• Registration Number: CTRI/2012/12/003195
• 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: 50

Inclusion Criteria

•Male or female greater than 18 years of age;

•Suspected or Culture proven gram positive bacteremia. Note â?? patients with mixed infections (i.e. with anaerobic or gram negative bacteremia in addition) may be included.

•End-stage renal disease (ESRD) patients on stable dialysis regimen

•Written informed consent prior to any study-related procedure not part of normal medical care;

•Considered to be in appropriate health for study entry by the Investigator (e.g., no acute, debilitating medical problems) and appropriate candidate for completing study treatment;

•If female of childbearing potential; willing to practice reliable birth control measures during study treatment, not lactating or pregnant, has a documented negative pregnancy test result within 24 hours prior to study medication administration, and willing to practice effective means of birth control for greater than 28 days after study completion;

•If infected catheter lines or devices (if any) are removed but patient continuing on daptomycin therapy data will still be collected. Removal of lines or devices will be at the discretion of the investigator as clinical indicated.

Exclusion Criteria

•Females: if pregnant or lactating;

•Received an investigational drug (including experimental biologic agents) within 30 days of study entry;

•Suspected or known concomitant infection which may interfere with the study outcome.

•Known to be allergic or intolerant to daptomycin;

•Patients with evidence of resistance to daptomycin

•Patients with only Gram negative bacteremia.

•Patients diagnosed with Peritonitis.

•Baseline creatinine phosphokinase (CPK) values 3X ULN (upper limit of normal);

•Known HIV-infected subjects with CD4 count less than or equal to 200 cells per cubic mm;

•Active illicit drug and/or alcohol abuse;

•Hospitalized for non-vascular or peritoneal dialysis (PD) access issues within 30 days;

•Subjects with a history of muscular disease (e.g., polymyositis, muscular dystrophy);

•Intramuscular injection within 7 days of study drug administration;

•Has a moribund clinical condition (i.e., high likelihood of death during the next 3 days);

•Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations;

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Clinical Outcome <br/ ><br>IA. Clinical Outcome Assessment: <br/ ><br>For each of the patients included in the clinical outcome at the end of daptomycin therapy (EOT) should be assessed using the following criteria: <br/ ><br> <br/ ><br>â?¢Cure <br/ ><br> <br/ ><br>â?¢Improved <br/ ><br> <br/ ><br>â?¢Failure <br/ ><br> <br/ ><br>â?¢Non-EvaluableTimepoint: at the end of daptomycin therapy (EOT)based on the discretion of the investigator after a minimum of 7 days of therapy with Daptomycin

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints: <br/ ><br> <br/ ><br>Efficacy end points: <br/ ><br>â?¢Duration of treatment <br/ ><br>â?¢Time to clinical improvement <br/ ><br> <br/ ><br>Safety end points: <br/ ><br>â?¢Adverse events <br/ ><br>â?¢Serious Adverse events (SAE) <br/ ><br>Timepoint: at the end of daptomycin therapy (EOT)based on the discretion of the investigator after a minimum of 7 days of therapy with Daptomycin