Cited by 433Antibiotic Use and ResistanceAntibiotics Pharmacokinetics and EfficacyUrinary Tract Infections Management

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Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial

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Yahav, Dafna, Franceschini, Erica, Koppel, Fidi, Turjeman, Adi, Babich, Tanya, Bitterman, Roni, Neuberger, Ami, Ghanem-Zoubi, Nesrin, Santoro, Antonella, Eliakim-Raz, Noa, Pertzov, Barak, Steinmetz, Tali, Stern, Anat, Dickstein, Yaakov, Maroun, Elias, Zayyad, Hiba, Bishara, Jihad, Alon, Danny, Edel, Yonatan, Goldberg, Elad, Venturelli, Claudia, Mussini, Cristina, Leibovici, Leonard, Paul, Mical, Bacteremia Duration Study Group·2019·Clinical Infectious Diseases

DOI 10.1093/cid/ciy1054

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Abstract

Background: Gram-negative bacteremia is a major cause of morbidity and mortality in hospitalized patients. Data to guide the duration of antibiotic therapy are limited. Methods: This was a randomized, multicenter, open-label, noninferiority trial. Inpatients with gram-negative bacteremia, who were afebrile and hemodynamically stable for at least 48 hours, were randomized to receive 7 days (intervention) or 14 days (control) of covering antibiotic therapy. Patients with uncontrolled focus of infection were excluded. The primary outcome at 90 days was a composite of all-cause mortality; relapse, suppurative, or distant complications; and readmission or extended hospitalization (>14 days). The noninferiority margin was set at 10%. Results: We included 604 patients (306 intervention, 298 control) between January 2013 and August 2017 in 3 centers in Israel and Italy. The source of the infection was urinary in 411 of 604 patients (68%); causative pathogens were mainly Enterobacteriaceae (543/604 [90%]). A 7-day difference in the median duration of covering antibiotics was achieved. The primary outcome occurred in 140 of 306 patients (45.8%) in the 7-day group vs 144 of 298 (48.3%) in the 14-day group (risk difference, –2.6% [95% confidence interval, –10.5% to 5.3%]). No significant differences were observed in all other outcomes and adverse events, except for a shorter time to return to baseline functional status in the short-course therapy arm. Conclusions: In patients hospitalized with gram-negative bacteremia achieving clinical stability before day 7, an antibiotic course of 7 days was noninferior to 14 days. Reducing antibiotic treatment for uncomplicated gram-negative bacteremia to 7 days is an important antibiotic stewardship intervention. Clinical Trials Registration: NCT01737320.

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Authors: Yahav, D., Franceschini, E., Koppel, F., Turjeman, A., Babich, T., Bitterman, R., Neuberger, A., Ghanem-Zoubi, N., Santoro, A., Eliakim-Raz, N., Pertzov, B., Steinmetz, T., Stern, A., Dickstein, Y., Maroun, E., Zayyad, H., Bishara, J., Alon, D., Edel, Y., Goldberg, E., Venturelli, C., Mussini, C., Leibovici, L., Paul, M., & Bacteremia Duration Study Group
Affiliations: Tel Aviv University (IL)
University of Modena and Reggio Emilia (IT)
Rambam Health Care Campus (IL)
Sackler Faculty of Medicine, Tel Aviv University, Ramat Aviv, Israel
Technion – Israel Institute of Technology (IL)
Infectious Diseases Institute, Rambam Health Care Campus, Haifa
Infectious Diseases Unit, Rabin Medical Center, Beilinson Hospital, Petah-Tikva
Rabin Medical Center (IL)
Corresponding author: Yahav, Dafna
ORCID: Yahav, Dafna
Franceschini, Erica
Babich, Tanya
Bitterman, Roni
Neuberger, Ami
Santoro, Antonella
Pertzov, Barak
Steinmetz, Tali
Stern, Anat
Dickstein, Yaakov
Maroun, Elias
Zayyad, Hiba
Bishara, Jihad
Edel, Yonatan
Goldberg, Elad
Venturelli, Claudia
Mussini, Cristina
Leibovici, Leonard
Paul, Mical
Venue: Clinical Infectious Diseases
Publisher: Oxford University Press (OUP)
Published: 2018-12-11
Volume: 69
Issue: 7
Pages: 1091-1098
ISSN: 1058-4838 (ISSN-L)
1537-6591
DOI: 10.1093/cid/ciy1054
OpenAlex: W2904708694
Cited by: 433
References: 19
Citations by year: 2026: 51 · 2025: 71 · 2024: 47 · 2023: 60 · 2022: 73 · 2021: 52 · 2020: 51 · 2019: 25 · 2018: 2
FWCI: 19.83
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: Clinical Infectious Diseases (publishedVersion)
PubMed (publishedVersion)
IRIS UNIMORE (University of Modena and Reggio Emilia) (submittedVersion, cc-by)
Topics: Health Sciences › Medicine › Infectious Diseases › Antibiotic Use and Resistance
Health Sciences › Medicine › Pharmacology (medical) › Antibiotics Pharmacokinetics and Efficacy
Health Sciences › Medicine › Urology › Urinary Tract Infections Management
Keywords: gram-negative bacteremia, antibiotic duration, short-course antibiotic therapy, non-inferiority, Enterobacteriaceae, urinary tract infection, antibiotic stewardship, all-cause mortality, relapse, hospital readmission, functional recovery
MeSH terms: Duration of Therapy, Aged, Aged, 80 and over, Anti-Bacterial Agents, Female, Humans, Male, Middle Aged, Bacteremia, Treatment Outcome, Gram-Negative Bacterial Infections

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Seven Versus 14 Days of Antibiotic Therapy for Uncomplicated Gram-negative Bacteremia: A Noninferiority Randomized Controlled Trial

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