Maria van Hove, Nick DeVito, 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 (EU) guidelines are broader: they require all trials of medicinal products registered on their EU Clinical Trials Registry (EUCTR) since 2004 to report results within one year of completion. Our FDAAA TrialsTracker and EU TrialsTracker show all individual trials that breach these legal requirements. Each week we write about one unreported clinical trial: you can read more background here, and past entries are here.

Trials NCT02660346

This week’s unreported trial is titled “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” (NCT02660346). 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.

Clinical discussion

Antibiotic resistant bacteria strains are a major global health concern. MSRA can often be spread in healthcare settings, but also commonly acquired in the community. Patients with MRSaB have high therapeutic failure and mortality rates. Prior work has shown higher mortality among MRSaB patients with elevated IL-10 levels.

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). Better 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.

Legislative discussion

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 PubMed and Google Scholar for the trial id and PI did not return any relevant publications.

Conclusion

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.

 

Maria Van Hove, junior doctor, current national medical director’s clinical fellow. 

 

Competing interests: None declared

 

 

Ben Goldacre is a doctor, author, and director of the EBM DataLab at the University of Oxford. He co-founded the AllTrials campaign for trials transparency.

Competing interests: 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.

Nicholas J DeVito is a researcher at the EBM Datalab at the University of Oxford.

Competing interests: ND is employed on BG’s LJAF grant and is a Naji Foundation scholar at the University of Oxford.