Oral decontamination with colistin plus neomycin in solid organ transplant recipients colonized by multidrug-resistant Enterobacterales: a multicentre, randomized, controlled, open-label, parallel-group clinical trial
| Autor: | Laura Linares, Julián Torre-Cisneros, Fernando Chaves, Antonio Cuadrado, Javier Nieto, María José Blanco, Irene Gracia-Ahufinger, José María Aguadov, Maitane Aranzamendi, Javier Graus, María Olmedo, Elena Resino, Teresa Vicente-Rangel, Marina Machado, Claudia González-Rico, Virginia Flor, Emilio Fábrega, Rosa Escudero-Sánchez, Ana M. Sánchez-Díaz, Ana Fernández, Miquel Navasa, Jorge Calvo, Fernando Casafont-Morencos, Francesc Marco, Asunción Moreno, Jesús Fortún, Pilar Martin Dávil, Francisco Arnaiz de las Revillas, María Luisa Rodríguez Ferrero, Miguel Montejo, María Carmen Fariñas, Marta Fernández-Martínez, Patricia Ruiz Garbajosa, Marta Bodro, Concepción Fariñas-Álvarez, Aitziber Illaro, Emilio Rodrigo, Fernando Rodríguez, Aurora Páez Vega, Juan Carlos Ruiz San Millán, Patricia Muñoz, Caroline Agnelli Bento, Adolfo Martínez, Luis Martínez-Martínez, Maricela Valerio, Frederic Cofan, Cristina Rincón Sanz, Carlos Armiñanzas, Luis Alberto Sánchez Cámara, Mónica Gozalo |
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| Přispěvatelé: | Universidad de Cantabria |
| Rok vydání: | 2021 |
| Předmět: |
Male
0301 basic medicine Microbiology (medical) medicine.medical_specialty Nausea 030106 microbiology Administration Oral Infections law.invention 03 medical and health sciences Enterobacterales 0302 clinical medicine Solid organ transplantation Enterobacteriaceae Randomized controlled trial law Drug Resistance Multiple Bacterial Internal medicine medicine Humans 030212 general & internal medicine Adverse effect Rectal colonization Multiresistance Aged Colistin business.industry Enterobacteriaceae Infections Rectum Neomycin Organ Transplantation General Medicine Middle Aged Rash Transplant Recipients Anti-Bacterial Agents Transplantation Infectious Diseases Relative risk Carrier State Vomiting Drug Therapy Combination Female medicine.symptom business medicine.drug |
| Zdroj: | Clin Microbiol Infect.2021 Jun;27(6):856-863 UCrea Repositorio Abierto de la Universidad de Cantabria Universidad de Cantabria (UC) |
| ISSN: | 1198-743X |
| DOI: | 10.1016/j.cmi.2020.12.016 |
| Popis: | Objectives To evaluate the efficacy of oral colistin-neomycin in preventing multidrug-resistant Enterobacterales (MDR-E) infections in solid organ transplant (SOT) recipients. Methods Multicentre, open-label, parallel-group, controlled trial with balanced (1:1) randomization in five transplant units. SOT recipients were screened for MDR-E intestinal colonization (extended-spectrum β-lactamase or carbapenemase producing) before transplantation and +7 and + 14 days after transplantation and assigned 1:1 to receive treatment with colistin sulfate plus neomycin sulfate for 14 days (decolonization treatment (DT) group) or no treatment (no decolonization treatment (NDT) group). The primary outcome was diagnosis of an MDR-E infection. Safety outcomes were appearance of adverse effects, mainly diarrhoea, rash, nausea and vomiting. Patients were monitored weekly until 30 days after treatment. Intention-to-treat analysis was performed. Results MDR-E rectal colonization was assessed in 768 SOT recipients; 105 colonized patients were included in the clinical trial, 53 receiving DT and 52 NDT. No significant decrease in the risk of infection by MDR-E was observed in the DT group (9.4%, 5/53) compared to the NDT group (13.5%, 7/52) (relative risk 0.70; 95% confidence interval 0.24–2.08; p 0.517). Four patients (5.6%), three (5.6%) in the DT group and one (1.9%) in the NDT group, developed colistin resistance. Twelve patients (22.7%) in the DT group had diarrhoea, eight related to treatment (15.0%); one patient (1.8%) developed skin rash and another (1.8%) nausea and vomiting. Two patients (3.8%) in the NDT group developed diarrhoea. Conclusions DT does not reduce MDR-E infections in SOT. Colistin resistance and adverse effects such as diarrhoea are a potential issue that must be taken seriously. |
| Databáze: | OpenAIRE |
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