Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections

Last updated: March 5, 2024
Sponsor: Hospital Moinhos de Vento
Overall Status: Terminated

Phase

N/A

Condition

Bacterial Infections

Sepsis And Septicemia

Soft Tissue Infections

Treatment

Duration of therapy

Clinical Study ID

NCT05210387
47366621.1.1001.5330
  • Ages > 18
  • All Genders

Study Summary

Antimicrobial resistance is a major global problem, particularly in hospital-acquired infections (HAIs). Gram-negative bacilli (GNB), including Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, are among the most common pathogens associated with multidrug resistance and HAIs. These bacteria are of special concern because few therapeutic options are available.

Traditionally, the duration of treatment for severe multidrug-resistant (MDR)-GNB infections is 14 days. Studies of severe infections by GNB, regardless of susceptibility profile, have shown that shorter antimicrobial treatments are not inferior to traditional durations of therapy and are associated with a lower incidence of adverse effects. However, there are currently no studies assessing whether shorter duration of antimicrobial treatment is effective for MDR-GNB.

This open-label, randomized clinical trial aims to assess the non-inferiority of 7-day antibiotic therapy compared to conventional 14-day treatment in severe infections by MDR-GNB.

Eligibility Criteria

Inclusion

Inclusion criteria

  • Infection's diagnosis while in the ICU

  • Severe infection in any site (defined as the presence of sepsis/septic shock or bloodstream infection or pneumonia) associated with a positive culture by MRD-GNB (Acinetobacter baumannii complex, Pseudomonas aeruginosa, and Enterobacterales bacteria, only susceptible to carbapenems and/or polymyxins)

  • Hemodynamically stable and afebrile (axillary temperature less than 37.8ºC) for at least 48 hours on day 7 of adequate antibiotic therapy

  • Consent of the team providing care to the patient regarding their inclusion in the research

Exclusion criteria

  • Inclusion in other experimental studies involving antimicrobial therapy

  • Infections that have as the primary site: endocarditis/endovascular infection, necrotizing fasciitis, osteomyelitis, abdominal abscess or other abdominal infections requiring surgical intervention (except infections that have been treated surgically, with curative character within the first 3 days of appropriate antimicrobial therapy), central nervous system Infections, empyema, prosthetic infection;

  • Immunosuppression defined as: neutrophil cells <1000/mm³ in the current hospitalization, HIV/AIDS diagnosis with last CD4 count <200/mm³, solid organ transplantation in the last year and/or need for increased immunosuppression due to acute rejection in the last year, hematopoietic stem cell transplantation in the last year, and/or current therapy for chronic graft-versus-host disease

  • Positive blood cultures for the same pathogen within 48 hours prior to randomization, when collected

  • Uncontrolled concomitant infection with another GNB (regardless of susceptibility profile)

  • Previous inclusion in this study

  • Known pregnancy

  • Patient in palliative care who has already decided not to restart antimicrobials, if necessary, or hemodynamic support measures.

Study Design

Total Participants: 107
Treatment Group(s): 1
Primary Treatment: Duration of therapy
Phase:
Study Start date:
January 27, 2022
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Hospital Cleriston de Andrade

    Feira De Santana, Bahia 44089-340
    Brazil

    Site Not Available

  • Hospital Couto Maia

    Salvador, Bahia
    Brazil

    Site Not Available

  • Hospital da Cidade

    Salvador, Bahia
    Brazil

    Site Not Available

  • Hospital OTO clinica

    Fortaleza, Ceará
    Brazil

    Site Not Available

  • Hospital Universitário de Brasília

    Brasília, Distrito Federal 70840-901
    Brazil

    Site Not Available

  • Instituto Hospital de Base do Distrito Federal

    Brasília, Distrito Federal 70330-150
    Brazil

    Site Not Available

  • Hospital Evangélico de Vila Velha

    Vila Velha, Espirito Santo 29118-060
    Brazil

    Site Not Available

  • Hospital Presidente Vargas

    São Luís, Maranhão 65040-450
    Brazil

    Site Not Available

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Minas Gerais 30150-221
    Brazil

    Site Not Available

  • Hospital Vila da Serra (Instituto Materno Infantil de Minas Gerais S/A)

    Nova Lima, Minas Gerais 34000-000
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Passos

    Passos, Minas Gerais 37904-020
    Brazil

    Site Not Available

  • Hospital Universitário da Universidade Estadual de Londrina

    Londrina, Paraná 86038-350
    Brazil

    Site Not Available

  • Hospital Municipal de Maringá

    Maringá, Paraná 87053-270
    Brazil

    Site Not Available

  • Hospital Regional Baixo Amazonas

    Santarém, Pará
    Brazil

    Site Not Available

  • Hospital do Tricentenário

    Olinda, Pernambuco 53120-420
    Brazil

    Site Not Available

  • Hospital São João Batista

    Volta Redonda, Rio De Janeiro
    Brazil

    Site Not Available

  • Hospital Tacchini

    Bento Gonçalves, Rio Grande Do Sul 95700-068
    Brazil

    Site Not Available

  • Hospital Geral Caxias do Sul

    Caxias Do Sul, Rio Grande Do Sul 95070-561
    Brazil

    Site Not Available

  • Hospital Ernesto Dornelles

    Porto Alegre, Rio Grande Do Sul 90160-092
    Brazil

    Site Not Available

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Hospital São Lucas da PUC

    Porto Alegre, Rio Grande Do Sul
    Brazil

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Hospital Ana Nery

    Santa Cruz Do Sul, Rio Grande Do Sul 96835-090
    Brazil

    Site Not Available

  • Hospital Santa Cruz

    Santa Cruz Do Sul, Rio Grande Do Sul 96810-072
    Brazil

    Site Not Available

  • Hospital São Lucas Sergipe - Rede D´or São Luiz

    Aracaju, Sergipe
    Brazil

    Site Not Available

  • Hospital Dr. Léo Orsi Bernadres - HLOB

    Itapetininga, São Paulo 18.030-070
    Brazil

    Site Not Available

  • Hospital Naval Marcílio Dias

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar)

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Hospital A.C Camargo

    São Paulo,
    Brazil

    Site Not Available

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