PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia

نویسندگان

  • Angela Huttner
  • Werner C Albrich
  • Pierre-Yves Bochud
  • Angèle Gayet-Ageron
  • Anne Rossel
  • Elodie von Dach
  • Stephan Harbarth
  • Laurent Kaiser
چکیده

INTRODUCTION Antibiotic overuse drives antibiotic resistance. The optimal duration of antibiotic therapy for Gram-negative bacteraemia (GNB), a common community and hospital-associated infection, remains unknown and unstudied via randomised controlled trials (RCTs). METHODS AND ANALYSIS This investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values. The randomisation will occur in equal proportions (1:1:1) on day 5 (±1) of efficacious antibiotic therapy as determined by antibiogram; patients, their physicians and study investigators will be blind to treatment duration allocation until the day of antibiotic discontinuation. Immunosuppressed patients and those with GNB due to complicated infections (endocarditis, osteomyelitis, etc) and/or non-fermenting bacilli (Acinetobacter spp, Burkholderia spp, Pseudomonas spp) Brucella spp, Fusobacterium spp or polymicrobial growth with Gram-positive organisms will be ineligible. The primary outcome is incidence of clinical failure at day 30; secondary outcomes include clinical failure, all-cause mortality and incidence of Clostridiumdifficile infection in the 90-day study period. An interim safety analysis will be performed after the first 150 patients have been followed for ≤30 days. Given a chosen margin of 10%, the required sample size to determine non-inferiority is roughly 500 patients. Analyses will be performed on both intention-to-treat and per-protocol populations. ETHICS AND DISSEMINATION Ethics approval was obtained from the cantonal ethics committees of all three participating sites. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER This trial is registered at www.clinicaltrials.gov (NCT03101072; pre-results).

برای دانلود رایگان متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Gram-negative bacteraemia in non-ICU patients: factors associated with inadequate antibiotic therapy and impact on outcomes.

BACKGROUND A considerable number of gram-negative bacteraemias occur outside intensive care units (ICUs). Inadequate antibiotic therapy in ICUs has been associated with adverse outcomes; however, there are no prospective studies in non-ICU patients. METHODS A 6 month (1 August 2006-31 January 2007), prospective cohort study of non-ICU patients with gram-negative bacteraemia in a tertiary-care...

متن کامل

Outcomes of septic shock due to multidrug resistant bacteraemia treated with phosphomycine

Methods Data from septic shock cases hospitalized in a tertiary ICU, during 2014, were retrospectively collected if patients had received phosphomycine i.v. at least for seventy-two hours, as rescue therapy for septic shock bacteraemia due to multidrug resistant (including colistin resistance) bacteria. Main outcomes (i.e. death in ICU, recovery from septic shock) were compared with cases of se...

متن کامل

Telepsychiatry- Based Care for the Treatment Follow-Up of Iranian War Veterans with Post-Traumatic Stress Disorder: A Randomized Controlled Trial

Background: Physical limitations, distance, and time are major obstacles to access to mental health services for veterans and soldiers. This study was aimed at comparing the efficacy of telepsychiatry and face-to-face consultation as methods of treating post-traumatic stress disorder (PTSD). The comparison was based on treatment costs, access to health services, completion of therapy sessions, ...

متن کامل

Short versus prolonged courses of antibiotic therapy for children with uncomplicated Gram-negative bacteraemia.

OBJECTIVES The optimal duration of antibiotic therapy for uncomplicated Gram-negative bacteraemia remains undefined. Our objective was to compare clinical outcomes of receiving short (7-10 days) versus prolonged (>10 days) durations of antibiotic therapy for children with uncomplicated Gram-negative bacteraemia. METHODS We conducted a retrospective cohort study of children with uncomplicated ...

متن کامل

Does combination antimicrobial therapy reduce mortality in Gram-negative bacteraemia? A meta-analysis.

The use of combination antimicrobial therapy for bacteraemia caused by Gram-negative bacilli is controversial. We did a meta-analysis of published studies to determine whether a combination of two or more antimicrobials reduces mortality in patients with Gram-negative bacteraemia. Criteria for inclusion were: analytic studies of patients with documented Gram-negative bacteraemia that included p...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

عنوان ژورنال:

دوره 7  شماره 

صفحات  -

تاریخ انتشار 2017