ArticleBMJ open2023
Randomised, open-label, non-inferiority clinical trial on the efficacy and safety of a 7-day vs 14-day course of antibiotic treatment for uncomplicated enterococcal bacteraemia: the INTENSE trial protocol.
Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05394298 (Randomized Non-inferiority Clinical Trial to Evaluate the Effectiveness and Security of Therapy for Non Complicated Enterococcal Bacteremia.), which is not on this map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Non-inferiority Clinical Trial to Evaluate the Effectiveness and Security of Therapy for Non Complicated Enterococcal Bacteremia.
Who cites it
8 citing papers in PubMed, 5 citations in OpenAlex.
- Oral transition therapy versus intravenous therapy for the treatment of uncomplicated Enterococcal bloodstream infections.Infection · 2026Article
- ManagingEClinicalMedicine · 2026Article
- Short course of antimicrobial treatment for uncomplicated enterococcal bacteremia.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2026Article
- Outcomes of early oral antibiotic transition for the treatment of uncomplicated enterococcal bacteremia.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2026Article
- Bridging the gap in bloodstream infection management: a survey among non-infectious disease physicians.JAC-antimicrobial resistance · 2025Article
- Association of vancomycin trough levels, AUC and AUC/MIC ratios with clinical outcomes in patients with enterococcal bacteremia: a prospective cohort study.BMC infectious diseases · 2025Article
- Oral switch antibiotic therapy in uncomplicatedJAC-antimicrobial resistance · 2025Article
- An Update on Recent Clinical Trial Data in Bloodstream Infection.Antibiotics (Basel, Switzerland) · 2024Review
Corrections and comments
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Authors and funding
12 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introduction
methodsThe INTENSE study is a multicentre, open-label, randomised, pragmatic, phase-IV clinical trial to demonstrate the non-inferiority of a 7-day vs 14-day course for the treatment of uncomplicated enterococcal bacteraemia and incorporating the early switching to oral antibiotics when feasible. The primary efficacy endpoint is the clinical cure at day 30±2 after the end of the treatment. Secondary endpoints will include the rate of relapse or infective endocarditis, length of stay, duration of intravenous therapy, ANALYSIS: The difference in proportions with one-sided 95% CIs will be calculated for the clinical cure rate using the control group as reference. For secondary categorical endpoints, a similar analysis will be performed and Mann-Whitney U-test will be used to compare median values of quantitative variables. A superiority analysis applying the response adjusted for days of antibiotic risk will be performed if there were incidents in recruitment; will allow obtaining results with 194 patients recruited. ETHICS AND DISSEMINATION: The study has obtained the authorisation from the Spanish Regulatory Authority, the approval of the ethics committee and the agreement of the directors of each centre. Data will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05394298.
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Registered trials
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