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Trial record 10 of 32 for:    Interleukin-10

IL-10 Stratifying Tool for Towards Antibiotic Selection for MRSaB

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02660346
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : February 1, 2018
Information provided by (Responsible Party):
Matthew Geriak, Sharp HealthCare

Brief 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.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: Daptomycin Drug: Vancomycin Drug: Ceftaroline Phase 4

Detailed Description:

Patients with MRSaB have primary therapeutic failure rates of 40-50% and high mortality rate of 10-50% when treated with the recommended standard antimicrobial therapy. (Sharp) local data for MRSaB for 2014 shows an all-cause mortality rate of 29%. Recent studies have been published that utilize the predictive biomarker, IL-10, aiding the understanding for the wide variability in mortality. Further studies are needed to elucidate the clinical relevance of utilizing IL-10 levels to optimize MRSaB management and whether or not patient outcomes are enhanced.

Under current standard treatment strategies, vancomycin 15 mg/kg IVPB every 12 hrs following a 30 mg/kg IVPB loading dose is the first line of antibiotic therapy initiated with known or suspected MRSaB. Only when patients have showed an unsatisfactory clinical response such as prolonged bacteremia and/or continued clinical signs of uncontrolled infection are more potent/aggressive and more expensive antibiotic choices considered in most cases. Even the time for consideration of such a switch is a matter of controversy, with current MRSA treatment guidelines recommending a switch after 7-days of failure.

Several recent studies have shown that an elevated IL-10 level is an independent risk factor of mortality. In animal models, it has been shown that the bacterial cell wall of Staphylococcus aureus stimulates the production of IL-10. A small study by Rose et al. showed that this observation is consistent in humans. In another study, the authors concluded that elevated IL-10 at the time of presentation is a predictive value of mortality in patients with MRSaB4. In addition, the authors concluded that IL-10 may serve as a biomarker for very early risk stratification, with selection of standard therapy for low-risk patients and more potent, expensive, and cumbersome antibiotic therapies reserved for the high-risk patients. Furthermore, it is postulated that treating high risk patients with aggressive/intensified therapy earlier may improve economic and microbiological outcomes, such as a decreased length of treatment, decreased time in the Intensive Care Unit, decreased length of stay in the hospital, and decreased duration of bacteremia.

The aim in this study is to compare the outcomes for patients with elevated IL-10 levels (≥ 8 pg/mL) when treated with standard antibiotic therapy versus early aggressive therapy for the treatment of MRSaB. Aggressive therapy is defined in study to be daptomycin (6-8mg/kg/day) with ceftaroline (600 mg q8hr).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2015
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Group A - Daptomycin or Vancomycin
Standard of Therapy of physician's choice, usually daptomycin 6-8 mg/kg IVPB daily or vancomycin IVPB adjusted dose per site protocol with a goal vancomycin trough level: 15-20 mcg/mL.
Drug: Daptomycin
Control Arm Treatment if used as monotherapy. Study Arm Treatment if used in combination with ceftaroline.
Other Name: Cubicin

Drug: Vancomycin
Control Arm Treatment
Other Name: Vancocin HCL

Experimental: Group B - Daptomycin with Ceftaroline
Daptomycin (6-8 mg/kg/day IVPB daily) with Ceftaroline (600 mg IVPB q8hr) to start within 72hrs of hospital admission. Daptomycin will be renally adjusted per package insert. Ceftaroline will be renally adjusted per institutional renal dosing recommendations for Q8h.
Drug: Daptomycin
Control Arm Treatment if used as monotherapy. Study Arm Treatment if used in combination with ceftaroline.
Other Name: Cubicin

Drug: Ceftaroline
Study Arm Treatment
Other Name: Teflaro

Primary Outcome Measures :
  1. Time to bacteremia clearance [ Time Frame: 1-4 weeks ]
    To determine whether or not early aggressive antibiotic therapy are correlated to shorter time to bacteremia clearance compared to standard therapy

Secondary Outcome Measures :
  1. Comparison of IL-10 levels between standard and aggressive therapy treatments [ Time Frame: About 2 months from blood draw to the batch results ]
    To determine whether or not patients who have high IL-10 levels treated with aggressive antibiotic therapy have better outcomes compared with standard therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult (≥ 18 years of age) men or women.
  • Diagnosis of MRSaB
  • Has not been treated with antibiotics for MRSaB within 7 days of admission
  • Has been on standard antibiotics for < 72hrs prior to randomization
  • In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy.

Exclusion Criteria:

  • Medical history of hypersensitivity or allergic reaction to vancomycin, or vancomycin derivatives, daptomycin or ceftaroline
  • Severe allergy to cephalosporins, i.e. Type 1 reaction, especially IgE mediated anaphylaxis
  • Comfort care patients
  • Death within 72hrs of the start of antibiotic therapy
  • Polymicrobial bacteremia: Staphylococcus aureus and another gram positive, gram negative or anaerobic pathogen
  • Burns covering ≥ 10% of body.
  • Pt currently enrolled in an investigational study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02660346

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United States, California
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
Sharp Memorial Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare
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Study Director: DeAnn Cary, PhD Sharp HealthCare

Additional Information:
Rose W, Berti AD, Hayney MS, Henriquez K, Ranzoni A, Cooper MA, Shukla SK, Proctor RA, Nizet V, Sakoulas G. Associaction of IL-10 concentrations with bacterial bloodstream inoculum and mortality in patients with Staphylococcus aureus bacteremia. 2014. Abstr. International Symposium Staphylococci & Staphylococcal Infections. abstr 207.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Matthew Geriak, Investigational Research Pharmacist, Sharp HealthCare Identifier: NCT02660346     History of Changes
Other Study ID Numbers: IL-10 MRSaB
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing any IPD with other researchers until the study is complete.

Keywords provided by Matthew Geriak, Sharp HealthCare:

Additional relevant MeSH terms:
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Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Ceftaroline fosamil
Anti-Infective Agents