Seven versus 14 days of antibiotic therapy for uncomplicated gram-negative bacteremia: a noninferiority randomized controlled trial
Open accessAbstract
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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Biomarker-guided strategies, randomized trials of bloodstream infection duration, and recent meta-analyses have shown that less antibiotic exposure can be appropriate in selected patients when clinical stability and source control are present.
“Biomarker-guided strategies, randomized trials of bloodstream infection duration, and recent meta-analyses have shown that less antibiotic exposure can be appropriate in selected patients when clinical stability and source control are present (24–29).”
From Day-4 antipseudomonal and anti-MRSA de-escalation was not associated with higher mortality in critically ill patients with sepsis (2026) · cites this paper as [27]
SARS-CoV-2 is responsible for many cases of infection and sepsis.
“More recently, SARS-CoV-2 (causing COVID-19) is now responsible for many cases of infection and sepsis (223).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [223]
The paper’s discussion of antibiotic treatment for gram-negative bacteremia (p. 1) and its infection-characteristics table (p. 5) do not address SARS-CoV-2. Searches for SARS-CoV-2, COVID-19, coronavirus, and viral sepsis found no passage supporting the attributed claim. (LLM, conf=0.78)
Experimental — accuracy not yet measuredIn many RCTs of shorter versus longer antimicrobial courses for specific conditions, the shorter course was as effective as the longer course but associated with fewer adverse consequences.
“In many of the trials, the shorter course was just as effective as the longer course but associated with fewer adverse consequences.”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [292]
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Hogan, C. A., Ebunji, B., Watz, N., Kapphahn, K., Rigdon, J., Mui, E., Meng, L., Alegria, W., Holubar, M. K., Deresinski, S. C., et al. (2020) · Journal of Clinical Microbiology · doi:10.1128/jcm.00360-20 · Cited by 29 · see citing works
Surapat, B., Montakantikul, P., Malathum, K., Kiertiburanakul, S., Santanirand, P., & Chindavijak, B. (2020) · BMC Infectious Diseases · doi:10.1186/s12879-020-05312-z · Cited by 29 · see citing works
Bitterman, R., Koppel, F., Mussini, C., Geffen, Y., Chowers, M., Rahav, G., Nesher, L., Ben‐Ami, R., Turjeman, ., Samuel, M. H., et al. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-040210 · Cited by 29 · see citing works
Self-citationSerum N-Glycomics Stratifies Bacteremic Patients Infected with Different Pathogens
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S3-Leitlinie Sepsis – Prävention, Diagnose, Therapie und Nachsorge – Update 2025
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Uses of Procalcitonin as a Biomarker in Critical Care Medicine
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Vance, M. K., Cretella, D. A., Ward, L. M., Vijayvargiya, P., Garrigos, Z. E., & Wingler, M. J. B. (2023) · Pharmacy · doi:10.3390/pharmacy11020074 · Cited by 28 · see citing works
İnce, D., Fiawoo, S., Choudhury, R., Cosgrove, S. E., Dobrzynski, D., Gold, H. S., Lee, J. H., Percival, K. M., Shulder, S., Sony, D., et al. (2023) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofad265 · Cited by 28 · see citing works
Jessen, L. R., Werner, M., Singleton, D., Prior, C., Foroutan, F., Ferran, A. A., Arenas, C., Bjørnvad, C. R., Lavy, E., Allerton, F., et al. (2024) · The Veterinary Journal · doi:10.1016/j.tvjl.2024.106208 · Cited by 27 · see citing works
Antibiotic duration for common bacterial infections—a systematic review
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Timsit, J., Wicky, P.-H., & de Montmollin, É. (2022) · Antibiotics · doi:10.3390/antibiotics11020144 · Cited by 27 · see citing works
Evaluation of early clinical failure criteria for gram-negative bloodstream infections
Winders, H. R., Gould, A. P., Bookstaver, P. B., Justo, J. A., Kohn, J. E., & Al‐Hasan, M. N. (2019) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2019.05.017 · Cited by 27 · see citing works
Jenkins, T. C., & Tamma, P. D. (2020) · Clinical Infectious Diseases · doi:10.1093/cid/ciaa1003 · Cited by 26 · see citing works
ten Doesschate, T., Kuiper, S., van Nieuwkoop, C., Hassing, R. J., Ketels, T., van Mens, S. P., van den Bijllaardt, W., van der Bij, A. K., Geerlings, S. E., Koster, A., et al. (2021) · Clinical Infectious Diseases · doi:10.1093/cid/ciab934 · Cited by 26 · see citing works
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Marıno, A., Augello, E., Bellanca, C. M., Cosentino, F., Stracquadanio, S., Via, L. L., Maniaci, A., Spampinato, S., Fadda, P., Cantarella, G., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26146905 · Cited by 24 · see citing works
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Howard-Anderson, J. R., Dai, W., Yahav, D., Hamasaki, T., Turjeman, ., Koppel, F., Franceschini, E., Hill, C. B., Sund, Z. M., Chambers, H. F. “., et al. (2022) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofac140 · Cited by 22 · see citing works
Self-citationSignificant Publications on Infectious Diseases Pharmacotherapy in 2018
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Duration of therapy recommended for bacteraemic illness varies widely amongst clinicians
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Uncomplicated Streptococcal Bacteremia: The Era of Oral Antibiotic Step-down Therapy?
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Ethics of Antibiotic Course Duration: Shorter is Better
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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
- 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
- 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
- Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antibiotic Use and Resistance
- Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
- Health Sciences › Medicine › Epidemiology › 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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