CTRI/2012/12/003195
Recruiting
Phase 4
An, observational study to evaluate the efficacy and safety of daptomycin in suspected or culture proven gram positive bacteremia in adults with End Stage Renal Disease on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis
ovartis Healthcare Pvt Ltd0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- gram positive bacteremia
- Sponsor
- ovartis Healthcare Pvt Ltd
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
To evaluate the effectiveness of ultrasound guided thoracic epidural block and serratus anterior plane block for pain relief after thoracic surgeies.CTRI/2023/08/056428ot applicable
Recruiting
Not Applicable
An observational study to evaluate the efficacy of suturing mucosal defects post duodenal endoscopic submucosal dissectiosuperficial non-ampullary duodenal epithelial tumorJPRN-UMIN000050513Keio University220
Not yet recruiting
Phase 2
An study to evaluate the requirement of post operative pain medication in patients undergoing thoracic surgeries if ultrasound guided serratus plane block and erector spinae plane block was giveHealth Condition 1: O- Medical and SurgicalCTRI/2023/07/055040A
Not yet recruiting
Phase 2
A study to see the effect of wet cupping on Acne vulgaris.Health Condition 1: L700- Acne vulgarisCTRI/2024/06/069418Islamic University of Science and technology
Recruiting
Not Applicable
The study to evaluate the effectiveness and safety of Elidel® in small children/babies affected by mild to moderate Atopic dermatitis (AD) in IndiaHealth Condition 1: L209- Atopic dermatitis, unspecifiedCTRI/2023/02/049923Mylan Pharmaceuticals Private Limited