NCT02972983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.6 years

First QC Date

November 21, 2016

Last Update Submit

September 18, 2020

Conditions

Methicillin Susceptible Staphylococcus Aureus SepticemiaBacteremia

Keywords

Staphylococcus aureusBacteremiaDaptomycin

Outcome Measures

Primary Outcomes (1)

  • Blood culture clearance

    Time between first positive and first negative blood culture

    5 days

Secondary Outcomes (5)

  • Mortality

    30 days

  • Adverse Reactions

    5 days

  • Intensive care admission

    30 days

  • Metastatic infection

    30 days

  • Recurrent infection

    30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia

Other: Placebo

Daptomycin

EXPERIMENTAL

51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia

Drug: Daptomycin

Interventions

DaptomycinDRUG

Adjuvant therapy for up to five days

Also known as: Cubicin
Daptomycin
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has a methicillin susceptible Staphylococcus aureus bacteremia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital)

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 29843781BACKGROUND

  • 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.

    PMID: 32667982BACKGROUND

MeSH Terms

Conditions

BacteremiaStaphylococcal Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsGram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Todd C Lee, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 21, 2016

First Posted

November 25, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

CA(1)