Dataset Information

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

ABSTRACT:

Objectives

To compare the effectiveness of an early switch to oral antibiotics with the standard 7 day course of intravenous antibiotics in severe community acquired pneumonia.

Design

Multicentre randomised controlled trial.

Setting

Five teaching hospitals and 2 university medical centres in the Netherlands.

Participants

302 patients in non-intensive care wards with severe community acquired pneumonia. 265 patients fulfilled the study requirements.

Intervention

Three days of treatment with intravenous antibiotics followed, when clinically stable, by oral antibiotics or by 7 days of intravenous antibiotics.

Main outcome measures

Clinical cure and length of hospital stay.

Results

302 patients were randomised (mean age 69.5 (standard deviation 14.0), mean pneumonia severity score 112.7 (26.0)). 37 patients were excluded from analysis because of early dropout before day 3, leaving 265 patients for intention to treat analysis. Mortality at day 28 was 4% in the intervention group and 6% in the control group (mean difference 2%, 95% confidence interval -3% to 8%). Clinical cure was 83% in the intervention group and 85% in the control group (2%, -7% to 10%). Duration of intravenous treatment and length of hospital stay were reduced in the intervention group, with mean differences of 3.4 days (3.6 (1.5) v 7.0 (2.0) days; 2.8 to 3.9) and 1.9 days (9.6 (5.0) v 11.5 (4.9) days; 0.6 to 3.2), respectively.

Conclusions

Early switch from intravenous to oral antibiotics in patients with severe community acquired pneumonia is safe and decreases length of hospital stay by 2 days.

Trial registration

Clinical Trials NCT00273676 [ClinicalTrials.gov].

SUBMITTER: Oosterheert JJ

PROVIDER: S-EPMC1693658 | biostudies-literature | 2006 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

Oosterheert Jan Jelrik JJ Bonten Marc J M MJ Schneider Margriet M E MM Buskens Erik E Lammers Jan-Willem J JW Hustinx Willem M N WM Kramer Mark H H MH Prins Jan M JM Slee Peter H Th J PH Kaasjager Karin K Hoepelman Andy I M AI

BMJ (Clinical research ed.) 20061107 7580

<h4>Objectives</h4>To compare the effectiveness of an early switch to oral antibiotics with the standard 7 day course of intravenous antibiotics in severe community acquired pneumonia.<h4>Design</h4>Multicentre randomised controlled trial.<h4>Setting</h4>Five teaching hospitals and 2 university medical centres in the Netherlands.<h4>Participants</h4>302 patients in non-intensive care wards with severe community acquired pneumonia. 265 patients fulfilled the study requirements.<h4>Intervention</h ...[more]

PMID: 17090560

Similar Datasets

Project description:ImportanceGram-negative bacteremia is a global health concern, and optimizing the transition from intravenous (IV) to oral antibiotics is a critical step in improving patient treatment and resource utilization.ObjectiveTo assess the association of switching to oral antibiotics within 4 days after initial blood culture with 90-day all-cause mortality compared with prolonged IV antibiotic treatment for patients with uncomplicated gram-negative bacteremia.Design, setting, and participantsThis cohort study conducted using the target trial emulation framework included observational data from adults with uncomplicated gram-negative bacteremia in 4 hospitals in Copenhagen, Denmark, from January 1, 2018, through December 31, 2021. The duration of follow-up was 90 days. Eligibility criteria included a blood culture positive for growth of gram-negative bacteria, clinical stability within 4 days of initial blood culture, an available susceptibility report on day 4, and initiation of appropriate empirical IV antibiotic treatment within 24 hours of blood culture.ExposureSwitching to oral antibiotics within 4 days after initial blood culture compared with continuing IV antibiotic treatment for at least 5 days after initial blood culture.Main outcomes and measuresThe main outcome was 90-day all-cause mortality. Inverse probability of treatment weighting was applied to adjust for confounding. Intention-to-treat and per-protocol analyses were performed using pooled logistic regression to estimate absolute risk, risk difference (RD), and risk ratio (RR); 95% CIs were computed using bootstrapping.ResultsA total of 914 individuals were included in the target trial emulation analysis (512 [56.0%] male; median age, 74.5 years [IQR, 63.3-83.2 years]); 433 (47.4%) transitioned early to oral antibiotic treatment, and 481 (52.6%) received prolonged IV treatment. Ninety-nine individuals (10.8%) died during follow-up. The proportion of individuals who died was higher in the group receiving prolonged IV treatment (69 [14.3%] vs 30 [6.9%]). In the intention-to-treat analysis, 90-day all-cause mortality risk was 9.1% (95% CI, 6.7%-11.6%) for the early-switch group and 11.7% (95% CI, 9.6%-13.8%) for the group receiving prolonged IV treatment; the RD was -2.5% (95% CI, -5.7% to 0.7%) and RR was 0.78 (95% CI, 0.60-1.10). In the per-protocol analysis, the RD was -0.1% (95% CI, -3.4% to 3.1%) and RR was 0.99 (95% CI, 0.70-1.40).Conclusions and relevanceIn this cohort study of uncomplicated gram-negative bacteremia, early transition to oral antibiotics within 4 days of initial blood culture was associated with 90-day all-cause mortality risk comparable to that of continuing IV antibiotic treatment and may be an effective alternative to prolonged IV treatment.

Project description:BackgroundEarly intravenous to oral (IV-PO) antibiotics switch, which is one of the important elements in antimicrobial stewardship (AMS) is not well implemented in Malaysian district hospitals. A systematic interventional strategy is required to facilitate IV-PO antibiotic switch.ObjectiveThis study aimed to evaluate the impact of printed AMS recommendations on early IV-PO antibiotics switch practice in district hospitals.MethodsThis study was an interventional study conducted in medical wards of eight Sarawak district hospitals from May to August 2015. In pre-intervention phase, pharmacists performed the conventional practice of reviewing medication charts and verbally informed the prescribers on eligible IV-PO switches. In post-intervention phase, pharmacists attached printed checklist which contained IV-PO switch criteria to patients' medical notes on the day patients were eligible for the switch. Stickers of IV-PO switch were applied to the antibiotic prescription to serve as reminders.Results79 and 77 courses of antibiotics were studied in the pre-intervention phase and post-intervention phase respectively. Timeliness of switch was improved by 1.63 days in the post-intervention phase (95%CI 1.26:2.00 days, p<0.001). Mean duration of IV antibiotics in the post-intervention phase was shorter than pre-intervention phase (2.81 days (SD=1.77) vs 4.05 days (SD=2.81), p<0.001). The proportion of IV-PO switches that were only performed upon discharge reduced significantly in the post-intervention phase (31.2% vs 82.3%, p<0.001). Length of hospital stay in the post-intervention phase was shortened by 1.44 days (p<0.001). Median antibiotic cost savings increased significantly in the post-intervention phase compared to the pre-intervention phase [MYR21.96 (IQR=23.23) vs MYR13.10 (IQR=53.76); p=0.025)].ConclusionsPharmacist initiated printed AMS recommendations are successful in improving the timeliness of IV-PO switch, reducing the duration of IV, reducing the length of hospitalisation, and increasing antibiotic cost savings.

Project description:ObjectivesEarly switch from intravenous to oral therapy of bioequivalent drugs has major advantages but remains challenging. At our hospital, a basic clinical rule was designed to automatically alert the physician to review potential intravenous to oral switch (IVOS). A rather low acceptance rate was observed. In this study, we aimed to develop, validate and investigate the effect of more advanced clinical rules for IVOS, as part of a centralised pharmacist-led medication review service.Design and settingA quasi-experimental study was performed in a large teaching hospital in Belgium using an interrupted time series design.InterventionA definite set of 13 criteria for IVOS, focusing on the ability of oral absorption and type of infection, was obtained by literature search and validated by a multidisciplinary expert panel. Based on these criteria, we developed a clinical rule for paracetamol and one for ten bioequivalent antibiotics to identify patients with potentially inappropriate intravenous prescriptions (PIVs). Postintervention, the clinical rule alerts were reviewed by pharmacists, who provided recommendations to switch in case of eligibility.Primary and secondary outcome measuresA regression model was used to assess the impact of the intervention on the number of persistent PIVs between the preintervention and the postintervention period. The total number of recommendations, acceptance rate and financial impact were recorded for the 8-month postintervention period.ResultsAt baseline, a median number of 11 (range: 7-16) persistent PIVs per day was observed. After the intervention, the number reduced to 3 (range: 1-7) per day. The advanced IVOS clinical rules showed an immediate relative reduction of 79% (incidence rate ratio=0.21, 95% CI 0.13 to 0.32; p<0.01) in the proportion of persistent PIVs. No significant underlying time trends were observed during the study. Postintervention, 1091 recommendations were provided, of which 74.1% were accepted, resulting in a total 1-day cost saving of €4648.35.ConclusionsWe showed the efficacy of advanced clinical rules combined with a pharmacist-led medication review for IVOS of bioequivalent drugs.

Project description:IntroductionCommunity-acquired pneumonia (CAP) causes around 10 hospitalisations per 1000 child-years, each associated with an average 13 non-routine days experienced and more than 4 parent workdays lost. In adults, steroid treatment shortens time to clinical stabilisation without an increase in complications in patients with CAP. However, despite promising data from observational studies, there is a lack of high-quality evidence for the use of steroids.Methods and analysisThe KIDS-STEP trial is a multicentre, randomised, double-blind, placebo-controlled superiority trial of betamethasone treatment on outcome of hospitalised children with CAP. Children are enrolled in paediatric emergency departments of hospitals across Switzerland and randomised to adjunct oral betamethasone for 2 days or matching placebo in addition to standard of care treatment. The co-primary outcomes are the proportion of children clinically stable 48 hours after randomisation and the proportion of children with CAP-related readmission within 28 days after randomisation. Secondary outcomes include length of hospital stay, time away from routine childcare and healthcare utilisation and total antibiotic prescriptions within 28 days from randomisation.Each of the co-primary outcomes will be analysed separately. We will test clinical stability rates using a proportion test; to test non-inferiority in readmission rates, we will construct 1-α % CI of the estimated difference and test if it contains the pre-defined margin of 7%. Success is conditional on both tests. A simulation-based sample size estimation determined that recruiting 700 patients will ensure a power of 80% for the study.Ethics and disseminationThe trial protocol and materials were approved by ethics committees in Switzerland (lead: Ethikkommission Nordwest und Zentralschweiz) and the regulatory authority Swissmedic. Participants and caregivers provide informed consent prior to study procedures commencing. The trial results will be published in peer-reviewed journals and at national and international conferences. Key messages will also be disseminated via press and social media where appropriate.Trial registration numberNCT03474991 and SNCTP000002864.

Dataset Information

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

Objectives

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusions

Trial registration

Publications

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets