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The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.

ABSTRACT: Background:Appropriate use of antimicrobials is essential to improve outcomes in sepsis. The aim of this study was to determine whether the use of a rapid molecular blood test-SeptiFast (SF) reduces the antibiotic consumption through early de-escalation in patients with nosocomial sepsis compared with conventional blood cultures (BCs). Methods:This was a prospective, randomized, superiority, controlled trial conducted at Sao Paulo Heart Institute in the period October 2012-May 2016. Adult patients admitted to the hospital for at least 48 h with a diagnosis of nosocomial sepsis underwent microorganism identification by both SF test and BCs. Patients randomized into the intervention group received antibiotic therapy adjustment according to the results of SF. Patients randomized into the control group received standard antibiotic adjustment according to the results of BCs. The primary endpoint was antimicrobial consumption during the first 14 days after randomization. Results:A total of 200 patients were included (100 in each group). The intention to treat analysis found no significant differences in median antibiotic consumption. In the subgroup of patients with positive SF and blood cultures (19 and 25 respectively), we found a statistically significant reduction in the median antimicrobial consumption which was 1429 (1071-2000) days of therapy (DOT)/1000 patients-day in the intervention group and 1889 (1357-2563) DOT/1000 patients-day in the control group (p?=?0.017), in the median time of antimicrobial de-escalation (8 versus 54 h-p?

SUBMITTER: Rodrigues C

PROVIDER: S-EPMC6647273 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.

Rodrigues Cristhieni C Siciliano Rinaldo Focaccia RF Filho Helio Caiaffa HC Charbel Cecília Eugenia CE de Carvalho Sarahyba da Silva Luciane L Baiardo Redaelli Martina M de Paula Rosa Passetti Ana Paula AP Franco Maria Renata Gomes MRG Rossi Flávia F Zeigler Rogerio R De Backer Daniel D Franco Rafael Alves RA de Almeida Juliano Pinheiro JP Rizk Stéphanie Itala SI Fukushima Julia Tizue JT Landoni Giovanni G Uip David Everson DE Hajjar Ludhmila Abrahão LA Strabelli Tania Mara Varejão TMV

Journal of intensive care 20190722

<h4>Background</h4>Appropriate use of antimicrobials is essential to improve outcomes in sepsis. The aim of this study was to determine whether the use of a rapid molecular blood test-Septi<i>Fast</i> (SF) reduces the antibiotic consumption through early de-escalation in patients with nosocomial sepsis compared with conventional blood cultures (BCs).<h4>Methods</h4>This was a prospective, randomized, superiority, controlled trial conducted at Sao Paulo Heart Institute in the period October 2012- ...[more]

PMID: 31367384

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Project description:BackgroundFluoroquinolones and second-line injectable drugs are the backbone of treatment regimens for multidrug-resistant tuberculosis, and resistance to these drugs defines extensively drug-resistant tuberculosis. We assessed the accuracy of an automated, cartridge-based molecular assay for the detection, directly from sputum specimens, of Mycobacterium tuberculosis with resistance to fluoroquinolones, aminoglycosides, and isoniazid.MethodsWe conducted a prospective diagnostic accuracy study to compare the investigational assay against phenotypic drug-susceptibility testing and DNA sequencing among adults in China and South Korea who had symptoms of tuberculosis. The Xpert MTB/RIF assay and sputum culture were performed. M. tuberculosis isolates underwent phenotypic drug-susceptibility testing and DNA sequencing of the genes katG, gyrA, gyrB, and rrs and of the eis and inhA promoter regions.ResultsAmong the 308 participants who were culture-positive for M. tuberculosis, when phenotypic drug-susceptibility testing was used as the reference standard, the sensitivities of the investigational assay for detecting resistance were 83.3% for isoniazid (95% confidence interval [CI], 77.1 to 88.5), 88.4% for ofloxacin (95% CI, 80.2 to 94.1), 87.6% for moxifloxacin at a critical concentration of 0.5 μg per milliliter (95% CI, 79.0 to 93.7), 96.2% for moxifloxacin at a critical concentration of 2.0 μg per milliliter (95% CI, 87.0 to 99.5), 71.4% for kanamycin (95% CI, 56.7 to 83.4), and 70.7% for amikacin (95% CI, 54.5 to 83.9). The specificity of the assay for the detection of phenotypic resistance was 94.3% or greater for all drugs except moxifloxacin at a critical concentration of 2.0 μg per milliliter (specificity, 84.0% [95% CI, 78.9 to 88.3]). When DNA sequencing was used as the reference standard, the sensitivities of the investigational assay for detecting mutations associated with resistance were 98.1% for isoniazid (95% CI, 94.4 to 99.6), 95.8% for fluoroquinolones (95% CI, 89.6 to 98.8), 92.7% for kanamycin (95% CI, 80.1 to 98.5), and 96.8% for amikacin (95% CI, 83.3 to 99.9), and the specificity for all drugs was 99.6% (95% CI, 97.9 to 100) or greater.ConclusionsThis investigational assay accurately detected M. tuberculosis mutations associated with resistance to isoniazid, fluoroquinolones, and aminoglycosides and holds promise as a rapid point-of-care test to guide therapeutic decisions for patients with tuberculosis. (Funded by the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Ministry of Science and Technology of China; ClinicalTrials.gov number, NCT02251327 .).

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The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.

Publications

The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.

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