A Randomized, Open-Label, Non-inferiority Clinical Trial Assessing 7 Versus 14 Days of Antimicrobial Therapy for Severe Multidrug-Resistant Gram-Negative Bacterial Infections : The OPTIMISE Trial Protocol
© 2023. The Author(s)..
INTRODUCTION: Shorter courses of antimicrobials have been shown to be non-inferior to longer, "traditional" duration of therapies, including for some severe healthcare-associated infections, with a few exceptions. However, evidence is lacking regarding shorter regimes against severe infections by multidrug-resistant Gram-negative bacteria (MDR-GNB), which are often caused by distinct strains and commonly treated with second-line antimicrobials. In the duratiOn of theraPy in severe infecTIons by MultIdrug-reSistant gram-nEgative bacteria (OPTIMISE) trial, we aim to assess the non-inferiority of 7-day versus 14-day antimicrobial therapy in critically ill patients with severe infections caused by MDR-GNB.
METHODS: This is a randomized, multicenter, open-label, parallel controlled trial to assess the non-inferiority of 7-day versus 14-day of adequate antimicrobial therapy for intensive care unit (ICU)-acquired severe infections by MDR-GNB. Adult patients with severe infections by MDR-GNB initiated after 48 h of ICU admission are screened for eligibility. Patients are eligible if they proved to be hemodynamically stable and without fever for at least 48 h on the 7th day of adequate antimicrobial therapy. After consenting, patients are 1:1 randomized to discontinue antimicrobial therapy on the 7th (± 1) day or to continue for a total of 14th (± 1) days.
PLANNED OUTCOMES: The primary outcome is treatment failure, defined as death or relapse of infection within 28 days after randomization. Non-inferiority will be achieved if the upper edge of the two-tailed 95% confidence interval of the difference between the clinical failure rate in the 7-day and the 14-day group is not higher than 10%.
CONCLUSION: The OPTIMISE trial is the first randomized controlled trial specifically designed to assess the duration of antimicrobial therapy in patients with severe infections by MDR-GNB.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05210387. Registered on 27 January 2022. Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections (OPTIMISE).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Infectious diseases and therapy - 13(2024), 1 vom: 01. Jan., Seite 237-250 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Arns, Beatriz [VerfasserIn] |
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| Links: |
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| Themen: |
Acinetobacter baumannii |
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| Anmerkungen: |
Date Revised 02.02.2024 published: Print-Electronic ClinicalTrials.gov: NCT05210387 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s40121-023-00897-9 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365931381 |
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| 100 | 1 | |a Arns, Beatriz |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Randomized, Open-Label, Non-inferiority Clinical Trial Assessing 7 Versus 14 Days of Antimicrobial Therapy for Severe Multidrug-Resistant Gram-Negative Bacterial Infections |b The OPTIMISE Trial Protocol |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 02.02.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05210387 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a INTRODUCTION: Shorter courses of antimicrobials have been shown to be non-inferior to longer, "traditional" duration of therapies, including for some severe healthcare-associated infections, with a few exceptions. However, evidence is lacking regarding shorter regimes against severe infections by multidrug-resistant Gram-negative bacteria (MDR-GNB), which are often caused by distinct strains and commonly treated with second-line antimicrobials. In the duratiOn of theraPy in severe infecTIons by MultIdrug-reSistant gram-nEgative bacteria (OPTIMISE) trial, we aim to assess the non-inferiority of 7-day versus 14-day antimicrobial therapy in critically ill patients with severe infections caused by MDR-GNB | ||
| 520 | |a METHODS: This is a randomized, multicenter, open-label, parallel controlled trial to assess the non-inferiority of 7-day versus 14-day of adequate antimicrobial therapy for intensive care unit (ICU)-acquired severe infections by MDR-GNB. Adult patients with severe infections by MDR-GNB initiated after 48 h of ICU admission are screened for eligibility. Patients are eligible if they proved to be hemodynamically stable and without fever for at least 48 h on the 7th day of adequate antimicrobial therapy. After consenting, patients are 1:1 randomized to discontinue antimicrobial therapy on the 7th (± 1) day or to continue for a total of 14th (± 1) days | ||
| 520 | |a PLANNED OUTCOMES: The primary outcome is treatment failure, defined as death or relapse of infection within 28 days after randomization. Non-inferiority will be achieved if the upper edge of the two-tailed 95% confidence interval of the difference between the clinical failure rate in the 7-day and the 14-day group is not higher than 10% | ||
| 520 | |a CONCLUSION: The OPTIMISE trial is the first randomized controlled trial specifically designed to assess the duration of antimicrobial therapy in patients with severe infections by MDR-GNB | ||
| 520 | |a TRIAL REGISTRATION: ClinicalTrials.gov, NCT05210387. Registered on 27 January 2022. Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections (OPTIMISE) | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Acinetobacter baumannii | |
| 650 | 4 | |a Antimicrobial resistance | |
| 650 | 4 | |a Antimicrobial therapy | |
| 650 | 4 | |a Enterobacterales | |
| 650 | 4 | |a Gram-negative bacilli | |
| 650 | 4 | |a Klebsiella pneumoniae | |
| 650 | 4 | |a Pseudomonas aeruginosa | |
| 700 | 1 | |a Horvath, Jaqueline Driemeyer C |e verfasserin |4 aut | |
| 700 | 1 | |a Rech, Gabriela Soares |e verfasserin |4 aut | |
| 700 | 1 | |a Sesin, Guilhermo Prates |e verfasserin |4 aut | |
| 700 | 1 | |a Agani, Crepin Aziz Jose Oluwafoumi |e verfasserin |4 aut | |
| 700 | 1 | |a da Rosa, Bruna Silveira |e verfasserin |4 aut | |
| 700 | 1 | |a Dos Santos, Tiago Marcon |e verfasserin |4 aut | |
| 700 | 1 | |a Brochier, Liliane Spencer Bittencourt |e verfasserin |4 aut | |
| 700 | 1 | |a Cavalcanti, Alexandre Biasi |e verfasserin |4 aut | |
| 700 | 1 | |a Tomazini, Bruno Martins |e verfasserin |4 aut | |
| 700 | 1 | |a Pereira, Adriano Jose |e verfasserin |4 aut | |
| 700 | 1 | |a Veiga, Viviane Cordeiro |e verfasserin |4 aut | |
| 700 | 1 | |a Nascimento, Giovana Marssola |e verfasserin |4 aut | |
| 700 | 1 | |a Kalil, Andre C |e verfasserin |4 aut | |
| 700 | 1 | |a Zavascki, Alexandre P |e verfasserin |4 aut | |
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