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

Not Applicable

Terminated

• Conditions: Pseudomonas Aeruginosa; Bacteremia; Acinetobacter Infections; Carbapenem Resistant Bacterial Infection; Carbapenem-Resistant Enterobacteriaceae Infection; Gram-Negative Bacterial Infections; Sepsis; Bloodstream Infection; Severe Infection; Human
• Interventions: Other: Duration of therapy

• Registration Number: NCT05210387
• Lead Sponsor: Hospital Moinhos de Vento

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2022-01-13
• Study Start: 2022-01-27
• Study First Posted: 2022-01-27
• Status Verified: 2023-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7-day adequate antibiotic therapy	Duration of therapy	Adequate antibiotic therapy is defined as antimicrobial treatment with at least one agent with in vitro susceptibility.
14-day adequate antibiotic therapy	Duration of therapy	Adequate antibiotic therapy is defined as antimicrobial treatment with at least one agent with in vitro susceptibility.

Primary Outcome Measures

Name	Time	Method
Clinical failure	28 days after randomization	Incidence of clinical failure. Clinical failure is a composite outcome defined by the presence of one of the following: Infection relapse (infection anywhere in the body by the same MDR-GNB) or Death

Secondary Outcome Measures

Name	Time	Method
Days alive and free from hospitalization	28 days after randomization	Number of days in which patients are alive and out of the hospital
Days alive and free from any antibiotic therapy	28 days after randomization	Number of days in which patients are alive and free from any antibiotic therapy
Length of intensive care unit stay	28 days after randomization	Number of days in which patients stayed at intensive care unit
Acute kidney injury	28 days after randomization	Incidence of acute kidney injury, according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Confirmed infection by Clostridioides difficile	28 days after randomization	Incidence of Clostridioides difficile infection
Hemodynamic instability lasting more than 6 hours	14 days after randomization	Incidence of hemodynamic instability lasting more than 6 hours. Hemodynamic instability is defined as hypotension that requires the use of doses of dopamine above 15 mcg/kg/min, epinephrine above 0.1 mcg/kg/min, or norepinephrine above 0.1 mcg/kg/min
Other adverse events related to antimicrobial therapy	28 days after randomization	Incidence of any other adverse event related to antimicrobial therapy
Diarrhea for any cause	28 days after randomization	Incidence of any diarrhea. Diarrhea is defined as 3 or more episodes per day.
Occurrence of infections caused by other MRD-GNB or other bacteria	28 days after randomization	Incidence of infections caused by other MRD-GNB or other bacteria

Trial Locations

Locations (29)

Hospital Cleriston de Andrade; 🇧🇷 Feira De Santana, Bahia, Brazil

Hospital da Cidade; 🇧🇷 Salvador, Bahia, Brazil

Santa Casa de Misericórdia de Belo Horizonte; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Vila da Serra (Instituto Materno Infantil de Minas Gerais S/A); 🇧🇷 Nova Lima, Minas Gerais, Brazil

Hospital Couto Maia; 🇧🇷 Salvador, Bahia, Brazil

Irmandade da Santa Casa de Misericórdia de Passos; 🇧🇷 Passos, Minas Gerais, Brazil

Hospital Universitário de Brasília; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital Geral Caxias do Sul; 🇧🇷 Caxias Do Sul, Rio Grande Do Sul, Brazil

Hospital Nossa Senhora da Conceição; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Ernesto Dornelles; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Santa Cruz; 🇧🇷 Santa Cruz Do Sul, Rio Grande Do Sul, Brazil

Hospital São Lucas da PUC; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Ana Nery; 🇧🇷 Santa Cruz Do Sul, Rio Grande Do Sul, Brazil

Hospital São João Batista; 🇧🇷 Volta Redonda, Rio De Janeiro, Brazil

Hospital Tacchini; 🇧🇷 Bento Gonçalves, Rio Grande Do Sul, Brazil

Hospital Municipal de Maringá; 🇧🇷 Maringá, Paraná, Brazil

Hospital Presidente Vargas; 🇧🇷 São Luís, Maranhão, Brazil

Hospital Universitário da Universidade Estadual de Londrina; 🇧🇷 Londrina, Paraná, Brazil

Hospital OTO clinica; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Regional Baixo Amazonas; 🇧🇷 Santarém, Pará, Brazil

Hospital do Tricentenário; 🇧🇷 Olinda, Pernambuco, Brazil

Instituto Hospital de Base do Distrito Federal; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital Evangélico de Vila Velha; 🇧🇷 Vila Velha, Espirito Santo, Brazil

Hospital São Lucas Sergipe - Rede D´or São Luiz; 🇧🇷 Aracaju, Sergipe, Brazil

Hospital Naval Marcílio Dias; 🇧🇷 Rio De Janeiro, Brazil

Hospital Dr. Léo Orsi Bernadres - HLOB; 🇧🇷 Itapetininga, São Paulo, Brazil

Hospital A.C Camargo; 🇧🇷 São Paulo, Brazil

Instituto Estadual do Cérebro Paulo Niemeyer (Pró Saúde- Associação Beneficente de Assistência Social e Hospitalar); 🇧🇷 Rio De Janeiro, Brazil