Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales: a randomized, controlled trial

Molina, José Antonio; Montero-Mateos, Enrique; Praena-Segovia, Julia; León-Jiménez, E.; Nátera, Clara; López-Cortés, Luis Eduardo; Valiente, Lucía Dolores Mesa; Rosso-Fernández, Clara; Herrero, Marta; Aller-García, Ana Isabel; Cano, Ángela; Gutiérrez‐Gutiérrez, Belén; Márquez-Gómez, Ignacio; Álvarez‐Marín, Rocío; Infante, Carmen; Roca, Cristina; Valiente-Méndez, Adoración; Pachón, Jerónimo; Reguera, J.M.; Corzo-Delgado, Juan E.; Torre‐Cisneros, Julián; Rodríguez-Baño, Jesús; Cisneros, José Miguel; Solano, B.; González-Galán, Verónica; Hinojosa, Esteban Fernández; López-Bernal, Francisco; Suñer, Marta; Noval, José Ángel; Giráldez, Álvaro; Navarro, Antonio José; Rodríguez-Hernández, María Jesús; Borrego, Yolanda; Gil, Paloma; Lepe, José Antonio Suárez; Morales, Isabel; Retamar, Pilar; Cueto, Marina de; Castón, Juan José; Vidal, Elisa

doi:10.1016/j.cmi.2021.09.001

Cited by 66 publications

(51 citation statements)

References 15 publications

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“…Our results are similar to the recently published study by Molina et al [ 8 ] who also performed a post hoc DOOR analysis of a trial comparing 7 versus 14 days of antibiotics for GNB. In the Molina et al [ 8 ] study, they used Response Adjusted for Duration of Antibiotic Risk (RADAR), a specific version of DOOR, which incorporates the total number of antibiotic days received in the DOOR endpoint (ie, if 2 participants had the same clinical outcome, the participant with the fewest antibiotic days would be given the more desirable rank) [ 9 ]. We did not use RADAR in our study because we chose to focus more directly on the clinical outcomes most impactful to patients rather than duration of antibiotics received, which closely tracked with assigned study arm in this study.…”

Section: Discussionsupporting

confidence: 91%

“…There have been 3 published randomized controlled trials (RCTs) assessing antibiotic duration in Gram-negative bacterial bloodstream infection (GNB) [ 6–8 ]. All studies demonstrated noninferiority with a short course (7 days) compared with a conventional course (14 days) of antibiotics with respect to a binary efficacy variable, and one study performed a post hoc desirability of outcome ranking (DOOR) analysis suggesting that a 7-day strategy might be preferred to 14 days [ 8 ]. More comprehensive benefit-to-risk analyses can help continue to elucidate effects of treatment duration on patient outcomes and inform the adoption of a treatment strategy for GNB.…”

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confidence: 99%

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A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection

Howard‐Anderson

Dai

Yahav

et al. 2022

Open Forum Infectious Diseases

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Background Although a short course (7 days) of antibiotics has been demonstrated to be non-inferior to a conventional course (14 days) in terms of mortality and infectious complications for patients with a Gram-negative bacterial bloodstream infection (GNB), it is unknown whether a shorter treatment duration can provide a better overall clinical outcome. Methods We applied a bloodstream infection-specific desirability of outcome ranking (DOOR) analysis to the results of a previously completed, randomized controlled trial comparing short versus conventional course antibiotic therapy for hospitalized patients with uncomplicated GNB. We determined the probability that a randomly selected participant in the short course group would have a more desirable overall outcome than a participant in the conventional duration group. We performed partial credit analyses allowing for calculated and variable weighting of DOOR ranks, and subgroup analyses to elucidate which patients may benefit the most from short durations of therapy. Results For the 604 patients included in the original study (306 short course, 298 conventional course), the probability of having a more desirable outcome with a short course of antibiotics compared to a conventional course was 51.1% (95% confidence interval 46.7% to 55.4%), indicating no significant difference. Partial credit analyses indicated that the DOOR results were similar across different patient preferences. Prespecified subgroup analyses using DOOR did not reveal significant differences between short and conventional courses of therapy. Conclusions Both short and conventional durations of antibiotic therapy provide comparable clinical outcomes when using DOOR to consider benefits and risks of treatment options for GNB.

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Section: Discussionsupporting

confidence: 91%

mentioning

confidence: 99%

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection

Howard‐Anderson

Dai

Yahav

et al. 2022

Open Forum Infectious Diseases

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“…These organizations did not participate in the analysis of the study. * Showed data have been summarized from supplementary file 8, included in the original manuscript [4].…”

Section: Conflict Of Interests the Authors Declared No Conflicts Of Interestsmentioning

confidence: 99%

Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by enterobacterales: a randomized, controlled trial: authors' response

Molina

Cisneros

2022

Clinical Microbiology and Infection

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Since 2019, three multicentre RCTs with concordant results have established that a 7-day treatment was not inferior to a 10-or 14-day treatment for patients with an uncomplicated GNB BSIs [68][69][70]. We highlight that all patients included in all three RCTs were immunocompetent, afebrile after 3 days of therapy and without uncontrolled infectious sources or prosthetic devices.…”

Section: When and How To Stop Therapymentioning

confidence: 77%

Use of Antimicrobials for Bloodstream Infections in the Intensive Care Unit, a Clinically Oriented Review

et al. 2022

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Bloodstream infections (BSIs) in critically ill patients are associated with significant mortality. For patients with septic shock, antibiotics should be administered within the hour. Probabilistic treatment should be targeted to the most likely pathogens, considering the source and risk factors for bacterial resistance including local epidemiology. Source control is a critical component of the management. Sending blood cultures (BCs) and other specimens before antibiotic administration, without delaying them, is key to microbiological diagnosis and subsequent opportunities for antimicrobial stewardship. Molecular rapid diagnostic testing may provide faster identification of pathogens and specific resistance patterns from the initial positive BC. Results allow for antibiotic optimisation, targeting the causative pathogen with escalation or de-escalation as required. Through this clinically oriented narrative review, we provide expert commentary for empirical and targeted antibiotic choice, including a review of the evidence and recommendations for the treatments of extended-spectrum β-lactamase-producing, AmpC-hyperproducing and carbapenem-resistant Enterobacterales; carbapenem-resistant Acinetobacter baumannii; and Staphylococcus aureus. In order to improve clinical outcomes, dosing recommendations and pharmacokinetics/pharmacodynamics specific to ICU patients must be followed, alongside therapeutic drug monitoring.

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Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales: a randomized, controlled trial

Cited by 66 publications

References 15 publications

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection

Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by enterobacterales: a randomized, controlled trial: authors' response

Use of Antimicrobials for Bloodstream Infections in the Intensive Care Unit, a Clinically Oriented Review

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