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

NCT05210387 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-03-06

No results posted yet for this 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.

Conditions

  • Carbapenem-Resistant Enterobacteriaceae Infection
  • Bloodstream Infection
  • Severe Infection
  • Pseudomonas Aeruginosa
  • Acinetobacter Infections
  • Gram-Negative Bacterial Infections
  • Human
  • Carbapenem Resistant Bacterial Infection
  • Bacteremia
  • Sepsis

Interventions

OTHER

Duration of therapy

In experimental group patients with severe infection caused by MDR-GNB and who present a clinical response on day 7 (±1) of adequate antimicrobial therapy, the therapy will be suspended. The active control group will continue therapy until day 14 (±1).

Sponsors & Collaborators

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Alexandre Prehn Zavascki · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210387 on ClinicalTrials.gov