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Role of asymptomatic bacteriuria on early periprosthetic joint infection after hip hemiarthroplasty. BARIFER randomized clinical trial

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Abstract

Purpose

To evaluate preoperative asymptomatic bacteriuria (ASB) treatment to reduce early-periprosthetic joint infections (early-PJIs) after hip hemiarthroplasty (HHA) for fracture.

Methods

Open-label, multicenter RCT comparing fosfomycin-trometamol versus no intervention with a parallel follow-up cohort without ASB. Primary outcome: early-PJI after HHA.

Results

Five hundred ninety-four patients enrolled (mean age 84.3); 152(25%) with ASB (77 treated with fosfomycin-trometamol/75 controls) and 442(75%) without. Despite the study closed without the intended sample size, ASB was not predictive of early-PJI (OR: 1.06 [95%CI: 0.33–3.38]), and its treatment did not modify early-PJI incidence (OR: 1.03 [95%CI: 0.15–7.10]).

Conclusions

Neither preoperative ASB nor its treatment appears to be risk factors of early-PJI after HHA. ClinicalTrials.gov Identifier: Eudra CT 2016-001108-47

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Acknowledgements

We thank Maria Romero (Trialance, S.C.C.L.) for medical writing support, Santiago Perez Hoyos (Unitat d’Estadística i Bioinformàtica (UEB)) for the statistical calculations, and Mercedes Vila for her assistance in the methodology and implementation of the project.

List of collaborators/group of investigators for BARIFER clinical trial

This is a multicenter study. In each institution, there are many researchers that have helped to make this study possible. We are deeply indebted to these collaborators, who are:

Jaume Mestre and Maria del Mar Villar (Internal Medicine Department, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain)

Álvaro Corrales Díaz and Myriam Rodríguez Rodríguez (Orthopedic Surgery Department Hospital Universitario Virgen Macarena, Seville, Spain)

Nerea Hernández González and Lorena Díez López (Orthopedic Surgery Department, Hospital Universitario Cruces, Vizcaya, Spain)

Javier Cobo (Infectious Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain) and Isabel Perez Millán (Geriatrics Department, Hospital Ramón y Cajal, Madrid, Spain).

Ma Isabel Perez Núñez (Orthopedic Surgery Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain), M Carmen Fariñas Alvarez (Infectious Diseases Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain), Hospital and Zoilo Yusta Escudero (Geriatrics Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain),

Elena Muñez Rubio, Isabel Sánchez Romero (Hospital Universitario Puerta de Hierro, Majadahonda, Spain).

Cristina Dauder Gallego (Orthopedic Surgery Department, Hospital Universitario Fundación Alcorcón. Madrid, Spain), Oriol Martin Segarra (Internal Medicine Department, Infectious Diseases Division, Hospital Universitario Fundación Alcorcón. Madrid, Spain), Jesús Ignacio Collado Álvarez and Ma Mar Bermejo Olano (Internal Medicine Department Hospital Universitario Fundación Alcorcón. Madrid, Spain).

Oscar Murillo (Infectious Diseases Department, Hospital Universitari de Bellvitge, Barcelona, Spain), Salvador Pedrero (Orthopedic Surgery Department Hospital Universitari de Bellvitge, Barcelona, Spain).

Melcior Riera (Internal Medicine Department, Hospital Universitario Son Espasses, Palma de Mallorca, Spain).

María Gomáriz Díaz (Microbiology Department. Hospital Universitario Donostia), Gaspar De la Herrán (Orthopedic Surgery Department. Hospital Universitario Donostia), H. Azkune (Infectious Diseases Department Hospital Universitario Donostia, San Sebastián, Spain).

Marta Almenara Fernández, Eduard Ramírez Bermejo, Judit Martínez Zaragoza, (Infectious Diseses Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain) Ferran Navarro Risueño (Microbiology Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain)

Funding

This work was supported by the Spanish Clinical Research Network (SCReN), co-finaced by the ISCIII-Subdirección General de Evaluación y Fomento de la Investigación, through the project PI15/02161 and by the Plan Nacional de I+D+i 2013-016 and ISCIIII, Subdireccion General de Redes y Centros de Investigacion Cooperativa, Ministerio de Economia, Industria y Competitividad, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003)-co-financed by European Development Regional Fund “A way to achieve Europe,” Operative program Intelligent Growth 2014-2020.

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Authors and Affiliations

  1. Infectious Diseases Department, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Pg. Vall d’Hebron 119-129, 08035, Barcelona, Spain

    Dolors Rodríguez-Pardo, Benito Almirante & Carles Pigrau

  2. Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0003), Instituto de Salud Carlos III, Madrid, Spain

    Dolors Rodríguez-Pardo, María Dolores del Toro, Laura Guío-Carrión, Marta Fernández-Sampedro, María Dolores Navarro, Mayli Lung, Pablo S. Corona, Benito Almirante & Carles Pigrau

  3. Study Group on Osteoarticular Infections of the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIO-SEIMC), Madrid, Spain

    Dolors Rodríguez-Pardo, María Dolores del Toro, Laura Guío-Carrión, Rosa Escudero-Sánchez, Marta Fernández-Sampedro, Miguel Ángel García-Viejo, María Velasco-Arribas, Laura Soldevila-Boixader, José Antonio Iribarren, María Dolores Navarro, Mayli Lung, Pablo S. Corona, Benito Almirante & Carles Pigrau

  4. Infectious Diseases Unit, Hospital Universitario Virgen Macarena, Departamento de Medicina, Universidad de Sevilla, Instituto de Biomedicina de Sevilla (IBiS), Seville, Spain

    María Dolores del Toro & María Dolores Navarro

  5. Infectious Diseases Department, Hospital Universitario Cruces, Barakaldo, Vizcaya, Spain

    Laura Guío-Carrión

  6. Infectious Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain

    Rosa Escudero-Sánchez

  7. Infectious Diseases Department, Hospital Universitario Marqués de Valdecilla, Santander, Spain

    Marta Fernández-Sampedro

  8. Internal Medicine Department, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain

    Miguel Ángel García-Viejo

  9. Internal Medicine Department (Infectious Diseases Division), Hospital Universitario Fundación Alcorcón, Madrid, Spain

    María Velasco-Arribas

  10. Infectious Diseases Department, Hospital Universitari de Bellvitge, Barcelona, Spain

    Laura Soldevila-Boixader

  11. Orthopedic Surgery Department, Hospital Universitario Son Espases, Palma de Mallorca, Spain

    Magdalena Femenias

  12. Infectious Diseases Department, Hospital Universitario Donostia IIS Biodonostia, San Sebastián, Spain

    José Antonio Iribarren

  13. Orthopedic Surgery Department, Hospital Santa Creu i Sant Pau, Barcelona, Spain

    María del Carmen Pulido-Garcia

  14. Microbiology Department, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain

    Mayli Lung

  15. Septic and Reconstructive Surgery Unit, Orthopedic Surgery Department, Vall d’Hebron Hospital Universitari, Vall d’Hebron Barcelona Hospital Campus, Barcelona, Spain

    Pablo S. Corona

Authors
  1. Dolors Rodríguez-Pardo
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  2. María Dolores del Toro
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  3. Laura Guío-Carrión
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  4. Rosa Escudero-Sánchez
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  5. Marta Fernández-Sampedro
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  6. Miguel Ángel García-Viejo
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  7. María Velasco-Arribas
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  11. María del Carmen Pulido-Garcia
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  12. María Dolores Navarro
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  13. Mayli Lung
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  15. Benito Almirante
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  16. Carles Pigrau
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Contributions

Dr Rodriguez-Pardo and Dr Pigrau contributed to its conception, clinical trial design, protocol, data collection, patient recruitment, data analysis, and writing the paper with the assistance of a medical writer. Dr Corona and Dr Almirante contributed to its conception, clinical trial design, and reviewing and editing the manuscript. All the other authors participated in patient recruitment, data collection, and reviewing and editing the manuscript. All authors approved the submitted versions, had full access to the data (under confidentiality agreements), and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol.

Corresponding author

Correspondence to Dolors Rodríguez-Pardo.

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The authors declare no competing interests.

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Rodríguez-Pardo, D., del Toro, M.D., Guío-Carrión, L. et al. Role of asymptomatic bacteriuria on early periprosthetic joint infection after hip hemiarthroplasty. BARIFER randomized clinical trial. Eur J Clin Microbiol Infect Dis 40, 2411–2419 (2021). https://doi.org/10.1007/s10096-021-04241-2

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