Vancomycin Versus Daptomycin for the Treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the efficacy of daptomycin treatment versus vancomycin treatment in the treatment of methicillin resistant staphylococcus aureus (MRSA) bloodstream infections (BSI) due to isolates with high vancomycin minimum inhibitory concentrations (MIC) (i.e. > or equal to 1.5 ug/ml) in terms of reducing all-cause mortality.

Our secondary aim is to compare clinical failure rates of daptomycin treatment versus vancomycin treatment and to compare time to microbiological clearance in patients treated with daptomycin versus those treated with vancomycin.

Our primary hypothesis is that Daptomycin treatment is superior to vancomycin treatment in reducing mortality from BSIs due to MRSA with high vancomycin MIC from 25% to 10%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore General Hospital
• Collaborator: Singapore Clinical Research Institute
• Treatments: Daptomycin; Vancomycin

Criteria

Inclusion Criteria:

• Age > 21 years.

• Inpatient at the time of enrolment.

• MRSA bacteremia due to MRSA isolates with a vancomycin MIC > 1.5 ug/ml.

• Be prepared to undergo all treatments and procedures, and attend follow-ups as per the trial protocol.

Exclusion Criteria:

• Allergy to any of the study medications.

• Pregnant or breastfeeding females.

• Unable to provide consent or have no legally authorized representatives.

• Currently enrolled or within the past three months participated in an interventional antibiotic or vaccine trial.

• >48 hours after MRSA vancomycin MIC > or equal to1.5 ug/ml confirmation by the microbiology laboratory (assessed from time of lab report).

• Patients on palliative care or with less than 24 hours of life expectancy (as discussed with their primary physicians).

• Polymicrobial bacteremia [see (a) below].

• Pneumonia [see (b) below].

• On treatment with linezolid, tigecycline or ceftaroline immediately prior to enrolment.

• Previous blood cultures positive for MRSA in the preceding one month.

• On vancomycin or daptomycin treatment for more than 96 hours prior to enrolment.

• BSI due to MRSA with vancomycin MIC > or equal to 4 ug/ml.

• Baseline serum creatine kinase more than 1.5 times the upper limit of normal.

• Patients with prosthetic heart valves

• Any other significant condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial.

1. .Isolation of a significant organism other than MRSA from index blood cultures or blood cultures taken up to two weeks prior to enrolment and/or for which the patient is still on treatment.

2. .Chest x-ray at baseline consistent with pneumonia AND at least 2 of the following signs and symptoms: New onset or worsening cough, purulent sputum or increased suctioning requirements, dyspnea/tachypnea or respiratory rate > 30/min, hypoxemia or worsening gas exchange as determined by study investigator.)