NCT05210387: OPTIMISE

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

Terminated NA Last updated 6 March 2024

What this trial tests

NA trial testing Duration of therapy in Carbapenem-Resistant Enterobacteriaceae Infection in 107 participants. Terminated before completion.

Timeline

27 January 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Hospital Moinhos de Vento
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	107
Start date	27 January 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	29 locations across Brazil

Drugs / interventions tested

• Duration of therapy

Conditions studied

• Carbapenem-Resistant Enterobacteriaceae Infection — all drugs for Carbapenem-Resistant Enterobacteriaceae Infection →
• Bloodstream Infection — all drugs for Bloodstream Infection →
• Severe Infection — all drugs for Severe Infection →
• Pseudomonas Aeruginosa — all drugs for Pseudomonas Aeruginosa →

Sponsor

Hospital Moinhos de Vento

Who can join

18 and older, any sex, with Carbapenem-Resistant Enterobacteriaceae Infection or Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Seven versus 14 days of antimicrobial therapy for severe multidrug-resistant Gram-negative bacterial infections in intensive care unit patients (OPTIMISE): a randomised, open-label, non-inferiority clinical trial.
   Arns B, Kalil AC, Sorio GGL, Boschi E, et al · · 2024 · cited 2× · PMID 39695798 · DOI 10.1186/s13054-024-05178-6
2. A Randomized, Open-Label, Non-inferiority Clinical Trial Assessing 7 Versus 14 Days of Antimicrobial Therapy for Severe Multidrug-Resistant Gram-Negative Bacterial Infections: The OPTIMISE Trial Protocol.
   Arns B, Horvath JDC, Rech GS, Sesin GP, et al · · 2024 · cited 1× · PMID 38102448 · DOI 10.1007/s40121-023-00897-9