Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Bacteremia Clinical Trial

— DASH  

Official title:

Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02972983
• Other study ID #: 2017-2666
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: September 2019

Study information

• Verified date: September 2020
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in combination with a beta lactam antibiotic on treating bloodstream infection caused by methicillin-susceptible S. aureus.

Description:

When patients have a blood infection with methicillin-susceptible S. aureus, they will all be treated with the usual standard of care, including abeta-lactam antibiotic, have their blood tested daily for the presence of the infection until they test negative, as well as an ultrasound of the heart to rule out an infection of the heart valves, as well as have any catheters removed (if possible) to ensure adequate control of the infection.

This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating blood infections due to Staphylococcus aureus. It is currently not used in combination with a beta-lactam for these infections because there is insufficient evidence of benefit to justify the cost.

The study participants will receive an additional daily iv therapy which will consist of either daptomycin or a placebo for a total of five days while admitted to the hospital. During this time, the participants will continue to have their blood drawn to assess for the presence of bacteria. The participants' liver and muscle enzymes will also be measured on the first and fifth day of therapy to test for potential side effects of the daptomycin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has a methicillin susceptible Staphylococcus aureus bacteremia.

Exclusion Criteria:

• Underlying terminal illness

• Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe adverse drug reaction)

• Expected death before 5 days

• Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN

Related Conditions & MeSH terms

• Bacteremia
• Methicillin Susceptible Staphylococcus Aureus Septicemia
• Sepsis

Intervention

Drug:
• Daptomycin
Adjuvant therapy for up to five days

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Cheng MP, Lawandi A, Butler-Laporte G, De l'Etoile-Morel S, Paquette K, Lee TC. Adjunctive Daptomycin in the Treatment of Methicillin-Susceptible Staphylococcus aureus Bacteremia: A Randomized Controlled Trial. Clin Infect Dis. 2020 Jul 15. pii: ciaa1000. doi: 10.1093/cid/ciaa1000. [Epub ahead of print] — View Citation

Cheng MP, Lawandi A, Butler-Laporte G, Paquette K, Lee TC. Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial. Trials. 2018 May 29;19(1):297. doi: 10.1186/s13063-018-2668-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood culture clearance	Time between first positive and first negative blood culture	5 days
Secondary	Mortality	Death from all causes (yes/no)	30 days
Secondary	Adverse Reactions	Daptomycin adverse reactions	5 days
Secondary	Intensive care admission	Admission to the intensive care unit (yes/no)	30 days
Secondary	Metastatic infection	The development of a new deep seated infection (e.g. osteomyelitis, abscess, endocarditis) not present at time of initial bacteremia	30 days
Secondary	Recurrent infection	The presence of a new positive blood culture occurring after the first negative culture and within 30 days of the initial positive	30 days