Trials / Terminated
TerminatedNCT05210387
Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections
Open-label, Randomized Clinical Trial to Assess the Non-inferiority of 7-day Antibiotic Therapy Compared to Conventional 14-day Treatment in Multidrug-resistant Gram-negative Bacilli Infections
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Hospital Moinhos de Vento · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2022-01-27
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2022-01-27
- Last updated
- 2024-03-06
Locations
29 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05210387. Inclusion in this directory is not an endorsement.