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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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  1. US Food and Drug Administration, Center for Drug Evaluation and Research., Complicated urinary tract infections: developing drugs for treatment guidance for industry. Available at:

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Metadata

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
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
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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