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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Arns, Beatriz Kalil, Andre C. Sorio, Guilherme G. L. Boschi, Emerson Antonio, Ana Carolina Peçanha Antonio, Juliana Peçanha Birriel, Daniella Cunha Lanziotti, Daniel Haase da Cunha Abbott, Frederico Rocha, Glecia Carla de Fátima Fernandes, Vanildes de Souza Dantas, Vicente Cés da Silva Medeiros, Graciele Fátima de França Diniz Rocha, Verônica Pereira, Francielle Constantino Gobatto, André Luiz Nunes Lima, Valéria Paes Lacerda, Fábio Holanda de Maio Carrilho, Cláudia Maria Dantas de Oliveira Cardozo, Kairo Daniel Nunes Irineu, Vivian Menezes Kurtz, Pedro Horvath, Jaqueline Driemeyer Correia Sesin, Guilhermo Prates Agani, Crepin Aziz Jose Oluwafoumi dos Santos, Tiago Marcon Brochier, Liliane Spencer Bittencourt da Rosa, Bruna Silveira Tomazini, Bruno Martins Besen, Bruno Adler Maccagnan Pinheiro Pereira, Adriano Jose Veiga, Viviane Cordeiro Nascimento, Giovana Marssola Zavascki, Alexandre P. |
| Abstract | Background Shorter courses of antimicrobial therapy have been shown to be non-inferior to longer durations for the management of several infections. However, data on critically ill patients with severe infections by multidrug-resistant Gram-negative bacteria (MDR-GNB) are scarce. In the duratiOn of theraPy in severe infecTIons by MultIdrug-reSistant gram-nEgative bacteria (OPTIMISE) trial, we assessed the non-inferiority of 7-day versus 14-day antimicrobial therapy for patients with intensive care unit (ICU)-acquired severe infections by MDR-GNB. Methods This was a randomised multicenter, open-label, parallel controlled, non-inferiority trial. Adult patients with severe infections by MDR-GNB initiated ≥ 48 h of ICU admission were eligible if they were hemodynamically stable and without fever > 48 h on the 7th day of appropriate antimicrobial therapy. Patients were 1:1 randomised to discontinue antimicrobial therapy on the 7th (± 1) day or to continue for a total of 14 (± 1) days. The primary outcome was clinical failure, defined as death or relapse of infection within 28 days of randomisation. An upper edge of the two-tailed 95% confidence interval (CI) of the delta between the clinical failure rate in the 7- and the 14-day lower than 10% in both intention-to-treat (ITT) and per protocol (PP) analyses was set as the non-inferiority criteria. Results A total of 106 patients composed the ITT population: 59 and 47 allocated to 7- and 14-day groups, respectively. The PP population included 75 patients: 47 and 28 in the 7- and 14-day groups, respectively. Clinical failure occurred in 42.4% and 44.7% of the ITT population in 7- and 14-day groups, respectively, (risk difference (RD) − 2.3, 95%CI − 21.3 to 16.7), and in 46.8% and 50.0% of the PP population in 7- and 14-day groups, respectively (RD − 3.2, 95%CI − 26.6 to 20.2). Most infections were of the respiratory tract (73/68.9%) and caused by carbapenem-resistant Enterobacterales (42/39.6%). The study was interrupted before reaching planned sample size due to low recruitment rate. Conclusion The OPTIMISE trial could not determine the non-inferiority of 7-day compared to 14-day therapy for severe infections caused by MDR-GNB due to early termination related to the low recruitment rate. Trial registration: NCT05210387 on January 13, 2022. |
| Related Links | https://ccforum.biomedcentral.com/counter/pdf/10.1186/s13054-024-05178-6.pdf |
| Ending Page | 12 |
| Page Count | 12 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 13648535 |
| DOI | 10.1186/s13054-024-05178-6 |
| Journal | Critical Care |
| Issue Number | 1 |
| Volume Number | 28 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2024-12-18 |
| Access Restriction | Open |
| Subject Keyword | Intensive Critical Care Medicine Emergency Medicine Enterobacterales Klebsiella pneumoniae Acinetobacter baumannii Pseudomonas aeruginosa Gram-negative bacteria Antimicrobial therapy Antimicrobial resistance |
| Content Type | Text |
| Resource Type | Article |
| Subject | Critical Care and Intensive Care Medicine |
| Journal Impact Factor | 8.8/2023 |
| 5-Year Journal Impact Factor | 10.4/2023 |
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