Clinical trial NCT02972983: Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
Official title: Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Methicillin Susceptible Staphylococcus Aureus Septicemia
Bacteremia
Keywords: Staphylococcus aureus
Bacteremia
Daptomycin
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood culture clearance
timeFrame: 5 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Adverse Reactions
timeFrame: 5 days
measure: Intensive care admission
timeFrame: 30 days
measure: Metastatic infection
timeFrame: 30 days
measure: Recurrent infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Todd C Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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. 2021 May 4;72(9):e196-e203. doi: 10.1093/cid/ciaa1000.