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
Primary result · Clinical failureResult — go to the resultRD - 2.3 95% CI - 21.3 to 16.7Authors' conclusion
The OPTIMISE trial could not determine the non-inferiority of 7-day compared to 14-day therapy for severe infections caused by MDR-GNB due to early termination related to the low recruitment rate.
Study context
- Population
- Adult intensive care unit (ICU) patients with ICU-acquired severe multidrug-resistant Gram-negative bacteria (MDR-GNB) infections, hemodynamically stable and without fever > 48 h on day 7 of appropriate therapyITT population
- Participants
- 106 patients
- Comparison
- 7-day vs 14-day antimicrobial therapy
- 7-dayn = 59
- 14-dayn = 47reference
- Primary endpoint
- Clinical failure (death or relapse of infection)
- Follow-up
- 28 days of randomisation
Methodological detailsmulticentre, open-label, parallel controlled, non-inferiority, Interrupted before reaching planned sample size due to low recruitment rate
- Multicentre
- Open-label
- Parallel controlled
- Non-inferiority
- Interrupted before reaching planned sample size due to low recruitment rate
Primary result
Clinical failure · 28 days
Risk difference (RD)
- 2.3
95% CI - 21.3 to 16.7
By group
As reported in the abstract
Further findings
Clinical failure, PP population · 28 days · PP
RD - 3.2 (- 26.6 to 20.2)
- Clinical failure, per protocol (PP) population: per protocol; 75 patients (47 and 28)
Original publication
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. Crit Care. Published 18 December 2024. doi:10.
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