Maria Carmen Fariñas1, Claudia González-Rico2, Marta Fernández-Martínez3, Jesús Fortún4, Rosa Escudero-Sanchez4, Asunción Moreno5, Marta Bodro5, Patricia Muñoz6, Maricela Valerio6, Miguel Montejo7, Javier Nieto7, Juan Carlos Ruiz-San Millan8, Fernando Casafont-Morencos9, Luis Martinez-Martínez10, Concepción Fariñas-Álvarez11. 1. Infectious Diseases Service, Hospital Universitario Marques de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. Electronic address: mcarmen.farinas@scsalud.es. 2. Infectious Diseases Service, Hospital Universitario Marques de Valdecilla, IDIVAL, Universidad de Cantabria, Santander, Spain. 3. Service of Microbiology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain. 4. Infectious Diseases Department, Hospital Universitario Ramon y Cajal, Madrid, Spain. 5. Infectious Diseases Service, Hospital Clinic-IDIBAPS, Universidad de Barcelona, Barcelona, Spain. 6. Clinical Microbiology and Infectious Diseases Department, Hospital General Universitario Gregorio Marañon, IiSGM, Universidad Complutense de madrid, Madrid, Spain. 7. Infectious Diseases Unit, Hospital Universitario de Cruces, Baracaldo, Vizcaya, Spain. 8. Nephrology Service, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain. 9. Liver Unit, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain. 10. Unit of Microbiology, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Cordoba, Cordoba, Spain. 11. Quality Unit, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
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.
RCT Entities:
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.
Authors: Marta Fernández-Martínez; Claudia González-Rico; Luis Martínez-Martínez; Maria Carmen Fariñas; Mónica Gozalo-Margüello; Francesc Marco; Irene Gracia-Ahufinger; Maitane Aranzamendi; Ana M Sánchez-Díaz; Teresa Vicente-Rangel; Fernando Chaves; Jorge Calvo Montes Journal: Sci Rep Date: 2021-06-04 Impact factor: 4.379