ABSTRACT
According to clinical guidelines, the management of catheter-related bloodstream infections (CRBSI) due to coagulase-negative staphylococci (CoNS) includes catheter removal and antibiotic treatment for 5 to 7 days. However, in low-risk episodes, it remains uncertain whether antibiotic therapy is necessary. This randomized clinical trial aims to determine whether the non-administration of antibiotic therapy is as safe and effective as the recommended strategy in low-risk episodes of CRBSI caused by CoNS. With this purpose, a randomized, open-label, multicenter, non-inferiority clinical trial was conducted in 14 Spanish hospitals from 1 July 2019 to 31 January 2022. Patients with low-risk CRBSI caused by CoNS were randomized 1:1 after catheter withdrawal to receive/not receive parenteral antibiotics with activity against the isolated strain. The primary endpoint was the presence of any complication related to bacteremia or to antibiotic therapy within 90 days of follow-up. The secondary endpoints were persistent bacteremia, septic embolism, time until microbiological cure, and time until the disappearance of a fever. EudraCT: 2017-003612-39 INF-BACT-2017. A total of 741 patients were assessed for eligibility. Of these, 27 were included in the study; 15 (55.6%) were randomized to the intervention arm (non-antibiotic administration) and 12 (44.4%) to the control arm (antibiotic therapy as per standard practice). The primary endpoint occurred in one of the 15 patients in the intervention group (septic thrombophlebitis) and in no patients in the control group. The median time until microbiological cure was 3 days (IQR 1-3) in the intervention arm and 1.25 days (IQR 0.5-2.62) in the control arm, while the median time until fever resolution was zero days in both arms. The study was stopped due to the insufficient number of recruited patients. These results seem to indicate that low-risk CRBSI caused by CoNS can be managed without antibiotic therapy after catheter removal; efficacy and safety are not affected.
ABSTRACT
INTRODUCTION: Few prospective studies analyze, with sufficient duration, the impact of an antimicrobial stewardship program (AMSP) carried out entirely in a hospital. METHODS: Descriptive study evaluating the consumption of antimicrobials expressed in defined daily doses (DDD) per 100 hospital occupied bed-days (OBDs) stratified in medical, surgical and intensive care unit (ICU) and the incidence of densities (ID) per 1,000 hospital OBDs of the prevalent multidrug-resistant organisms (MDRO) in a tertiary hospital, over a period of 5 years before and after the implementation of an AMSP. Analysis of direct costs and those associated with hospital stay and mortality. RESULTS: A total of 32,802 patients with antibiotic treatment were included in the intervention period (2013-2017). Non-imposed advice was exercised in 14.9%. The degree of adherence to recommendation was 87.9%, direct treatment and de-escalation being the most frequently admitted interventions (P<0.001). Overall hospital consumption of antibacterials in DDD/100s decreased by 5.7% (77.04 vs. 71.33) between 2008 and 2017. In ICU, the average DDD/100s showed a reduction from 155 to 113 (mean difference -18, P=0.005). There was a decrease in the DI/1000 OBDs of MDROs in the post-intervention period (RR 0.78; CI 95% [0.73, 0.84], P<0.001). The average annual cost of antibacterials declined from 1,435,048 to 955,805 (mean difference -469,243; P=0.001). CONCLUSION: Long-term maintenance of a hospital AMSP was associated with a reduction in antibiotic consumption, especially in ICU, as well as a beneficial ecological impact and economic savings.
