Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales : a randomized, controlled trial
Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved..
OBJECTIVE: To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes.
METHODS: A randomized trial was performed. Adult patients developing eBSI with appropriate source control were assigned to 7 or 14 days of treatment, and followed 28 days after treatment cessation; treatments could be resumed whenever necessary. The primary endpoint was days of treatment at the end of follow-up. Clinical outcomes included clinical cure, relapse of eBSI and relapse of fever. A superiority margin of 3 days was set for the primary endpoint, and a non-inferiority margin of 10% was set for clinical outcomes. Efficacy and safety were assessed together with a DOOR/RADAR (desirability of outcome ranking and response adjusted for duration of antibiotic risk) analysis.
RESULTS: 248 patients were assigned to 7 (n = 119) or 14 (n = 129) days of treatment. In the intention-to-treat analysis, median days of treatment at the end of follow-up were 7 and 14 days (difference 7, 95%CI 7-7). The non-inferiority margin was also met for clinical outcomes, except for relapse of fever (-0.2%, 95%CI -10.4 to 10.1). The DOOR/RADAR showed that 7-day schemes had a 77.7% probability of achieving better results than 14-day treatments.
CONCLUSIONS: 7-day schemes allowed a reduction in antibiotic exposure of patients with eBSI while achieving outcomes similar to those of 14-day schemes. The possibility of relapsing fever in a limited number of patients, without relevance to final outcomes, may not be excluded, but was overcome by the benefits of shortening treatments.
| Errataetall: |
CommentIn: Clin Microbiol Infect. 2022 Apr;28(4):463-464. - PMID 34823011 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
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| Enthalten in: |
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases - 28(2022), 4 vom: 01. Apr., Seite 550-557 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Anti-Bacterial Agents |
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| Anmerkungen: |
Date Completed 05.04.2022 Date Revised 05.05.2022 published: Print-Electronic CommentIn: Clin Microbiol Infect. 2022 Apr;28(4):463-464. - PMID 34823011 Citation Status MEDLINE |
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| doi: |
10.1016/j.cmi.2021.09.001 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM330510940 |
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| 100 | 1 | |a Molina, José |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Seven-versus 14-day course of antibiotics for the treatment of bloodstream infections by Enterobacterales |b a randomized, controlled trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 05.04.2022 | ||
| 500 | |a Date Revised 05.05.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Clin Microbiol Infect. 2022 Apr;28(4):463-464. - PMID 34823011 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved. | ||
| 520 | |a OBJECTIVE: To prove that 7-day courses of antibiotics for bloodstream infections caused by members of the Enterobacterales (eBSIs) allow a reduction in patients' exposure to antibiotics while achieving clinical outcomes similar to those of 14-day schemes | ||
| 520 | |a METHODS: A randomized trial was performed. Adult patients developing eBSI with appropriate source control were assigned to 7 or 14 days of treatment, and followed 28 days after treatment cessation; treatments could be resumed whenever necessary. The primary endpoint was days of treatment at the end of follow-up. Clinical outcomes included clinical cure, relapse of eBSI and relapse of fever. A superiority margin of 3 days was set for the primary endpoint, and a non-inferiority margin of 10% was set for clinical outcomes. Efficacy and safety were assessed together with a DOOR/RADAR (desirability of outcome ranking and response adjusted for duration of antibiotic risk) analysis | ||
| 520 | |a RESULTS: 248 patients were assigned to 7 (n = 119) or 14 (n = 129) days of treatment. In the intention-to-treat analysis, median days of treatment at the end of follow-up were 7 and 14 days (difference 7, 95%CI 7-7). The non-inferiority margin was also met for clinical outcomes, except for relapse of fever (-0.2%, 95%CI -10.4 to 10.1). The DOOR/RADAR showed that 7-day schemes had a 77.7% probability of achieving better results than 14-day treatments | ||
| 520 | |a CONCLUSIONS: 7-day schemes allowed a reduction in antibiotic exposure of patients with eBSI while achieving outcomes similar to those of 14-day schemes. The possibility of relapsing fever in a limited number of patients, without relevance to final outcomes, may not be excluded, but was overcome by the benefits of shortening treatments | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Antimicrobial stewardship | |
| 650 | 4 | |a Bacteraemia | |
| 650 | 4 | |a Bloodstream infections | |
| 650 | 4 | |a DOOR/RADAR | |
| 650 | 4 | |a Treatment duration | |
| 650 | 7 | |a Anti-Bacterial Agents |2 NLM | |
| 700 | 1 | |a Montero-Mateos, Enrique |e verfasserin |4 aut | |
| 700 | 1 | |a Praena-Segovia, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a León-Jiménez, Eva |e verfasserin |4 aut | |
| 700 | 1 | |a Natera, Clara |e verfasserin |4 aut | |
| 700 | 1 | |a López-Cortés, Luis E |e verfasserin |4 aut | |
| 700 | 1 | |a Valiente, Lucía |e verfasserin |4 aut | |
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| 700 | 1 | |a Gutiérrez-Gutiérrez, Belén |e verfasserin |4 aut | |
| 700 | 1 | |a Márquez-Gómez, Ignacio |e verfasserin |4 aut | |
| 700 | 1 | |a Álvarez-Marín, Rocío |e verfasserin |4 aut | |
| 700 | 1 | |a Infante, Carmen |e verfasserin |4 aut | |
| 700 | 1 | |a Roca, Cristina |e verfasserin |4 aut | |
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| 700 | 1 | |a Reguera, José María |e verfasserin |4 aut | |
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| 700 | 1 | |a Giráldez, Álvaro |e investigator |4 oth | |
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| 700 | 1 | |a Rodríguez-Hernández, María Jesús |e investigator |4 oth | |
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| 700 | 1 | |a Lepe, José Antonio |e investigator |4 oth | |
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