{"id":44072,"date":"2019-02-13T15:56:27","date_gmt":"2019-02-13T14:56:27","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=44072"},"modified":"2019-02-13T16:09:21","modified_gmt":"2019-02-13T15:09:21","slug":"unreported-trial-of-the-week-utilizing-interleukin-10-il-10-levels-as-a-guide-for-antibiotic-selection-in-mrsab-infection-nct02660346","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2019\/02\/13\/unreported-trial-of-the-week-utilizing-interleukin-10-il-10-levels-as-a-guide-for-antibiotic-selection-in-mrsab-infection-nct02660346\/","title":{"rendered":"Unreported trial of the week: Utilizing Interleukin 10 levels as a guide for antibiotic selection in MRSaB infection (NCT02660346)"},"content":{"rendered":"

Maria van Hove,\u00a0Nick\u00a0DeVito, Ben Goldacre<\/p>\n

Background<\/em><\/strong><\/p>\n

The US FDA Amendments Act (FDAAA 2007) requires certain clinical trials to report their results onto ClinicalTrials.gov within one year of completion. European Union (EU) guidelines are broader: they require\u00a0all trials of medicinal products registered on their\u00a0EU Clinical Trials Registry<\/a>\u00a0(EUCTR) since 2004 to report results within one year of completion. Our\u00a0FDAAA TrialsTracker<\/a>\u00a0and\u00a0EU TrialsTracker<\/a>\u00a0show all individual trials that breach these legal requirements. Each week we write about one unreported clinical trial: you can read more background\u00a0here<\/a>,\u00a0and past entries are\u00a0here<\/a>.<\/p>\n

Trials NCT02660346<\/em><\/strong><\/p>\n

This week\u2019s unreported trial is titled \u201cA 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\u201d (NCT02660346<\/a>). This was a phase 4 study conducted in adults with methicillin-resistant Staphylococcus aureus bacteremia (MRSaB), which occurs when a drug-resistant staph infection enters the bloodstream. Participants with MRSaB and elevated IL-10 levels (>8pg\/ml) were randomised to receive either standard antibiotic therapy (Daptomycin or Vancomycin) or early aggressive therapy (Daptomycin with Ceftaroline). The primary outcome measure was time to bacteremia clearance. The secondary outcome measure was IL-10 levels between the standard and aggressive therapy treatment groups.<\/p>\n

Clinical discussion<\/em><\/strong><\/p>\n

Antibiotic resistant bacteria strains are a\u00a0major global health concern<\/a>.\u00a0MSRA can often be spread<\/a>\u00a0in healthcare settings, but also commonly acquired in the community. Patients with MRSaB have\u00a0high therapeutic failure and mortality rates<\/a>.\u00a0Prior work<\/a>\u00a0has shown\u00a0higher mortality<\/a>\u00a0among MRSaB patients with elevated\u00a0IL-10 levels<\/a>.<\/p>\n

This study aims to determine whether early treatment with a more aggressive antibiotic therapy regimen (Daptomycin with Ceftaroline) following detection of an elevated IL-10 level improves outcomes for these participants compared to standard therapy (Daptomycin or Vancomycin).\u00a0Better understanding of risk-stratification for patients based on IL-10 may improve economic and microbiological outcomes, including a decrease in length of treatment and a decrease in length of hospital stay.<\/p>\n

Legislative discussion<\/em><\/strong><\/p>\n

As discussed in previous UTOTW, the FDAAA 2007 required results to be reported directly to ClinicalTrials.gov, in their standard tabular format. However, a search of\u00a0PubMed<\/a>\u00a0and\u00a0Google Scholar<\/a>\u00a0for the trial id and PI did not return any relevant publications.<\/p>\n

Conclusion<\/em><\/strong><\/p>\n

This unreported trial was sponsored by Sharp Healthcare, a healthcare system in San Diego, USA. The PI is Matthew Geriak of Sharp Healthcare who also provided the information for the trial. As of 28th January 2019, this trial is 134 days overdue to report. We hope the sponsor will report the results of this trial soon.<\/p>\n

 <\/p>\n

\"\"<\/a>Maria Van Hove<\/strong>, j<\/span>unior doctor, current national medical director\u2019s clinical fellow.\u00a0<\/span><\/em><\/p>\n

 <\/p>\n

Competing interests<\/strong>: None declared<\/p>\n

 <\/p>\n

 <\/p>\n

\"\"<\/a>Ben Goldacre<\/strong> is a doctor, author, and director of the EBM DataLab at the University of Oxford. He co-founded the AllTrials campaign for trials transparency.<\/em><\/p>\n

Competing interests<\/strong>: BG has received research funding from the Laura and John Arnold Foundation, the Wellcome Trust, the Oxford Biomedical Research Centre, the NHS National Institute for Health Research School of Primary Care Research, the Health Foundation, and the World Health Organization; he also receives personal income from speaking and writing for lay audiences on the misuse of science.<\/p>\n

\"\"<\/a><\/p>\n

Nicholas J DeVito<\/strong> is a researcher at the EBM Datalab at the University of Oxford.<\/em><\/p>\n

Competing interests<\/strong>: ND is employed on BG\u2019s LJAF grant and is a Naji Foundation scholar at the University of Oxford.<\/p>\n","protected":false},"excerpt":{"rendered":"

Maria van Hove,\u00a0Nick\u00a0DeVito, Ben Goldacre Background The US FDA Amendments Act (FDAAA 2007) requires certain clinical trials to report their results onto ClinicalTrials.gov within one year of completion. European Union […]<\/p>\n

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