CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Daptomycin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02660346
NCT02660346Phase 4Completed
CompareCT.gov

A Multi-center Prospective Randomized Open Label Study of Utilizing Interleukin 10 (IL-10) Levels as a Guide for Antibiotic Selection for Methicillin Resistant Staphylococcus Aureus Bacteremia

Sharp HealthCare·interventional·Posted Jan 21, 2016·Updated Feb 1, 2018

In Brief

A Phase 4 clinical trial evaluating Daptomycin, Vancomycin, and 1 other intervention for Bacteremia. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

Patients with MRSaB have high therapeutic failure rates and mortality rates. Recent studies have shown that an elevated IL-10 level is an independent risk factor of mortality. It may also serve as biomarker for very early risk stratification. The aim of this study is to compare the outcomes for patients with elevated IL-10 levels (≥8 pg/ml) when treated with standard antibiotic therapy (daptomycin or vancomycin) versus early aggressive therapy (daptomycin with ceftaroline) for the treatment of MRSaB.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacteremia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 21, 2016
Enrollment StartNov 1, 2015
Primary CompletionSep 15, 2017
Study CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.4 years ago

Interventions

Daptomycindrug

Control Arm Treatment if used as monotherapy. Study Arm Treatment if used in combination with ceftaroline.

Vancomycindrug

Control Arm Treatment

Ceftarolinedrug

Study Arm Treatment