1. 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
- Author
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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, and Universidad de Cantabria
- Subjects
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 - Abstract
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.
- Published
- 2021
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