NCT02400268

Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae

Phase 4, Randomized, Controlled Multicentric, Open-label Clinical Trial to Prove That the 7 Day Course of Treatment for Enterobacteriaceae Bacteremia is More Efficient and Equally Safe Than 14 Day Scheme

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The antimicrobial crisis is a real problem. Infections produced by multiresistant bacteria are becoming more and more frequent, and available antimicrobial agents are usually scarce. Reducing the duration of antimicrobial treatments is one of the most efficient measures to control the antibiotic pressure and to optimise the use of these agents. Bloodstream infections produced by Enterobacteria (EB) are very frequent, but the optimal duration of antibiotics to treat them is unknown, as long as no clinical trials have been specifically developed to answer this question. Basing on expert opinions, the Infectious Diseases Society pf America (IDSA) recommends the bacteremia by EB secondary to vascular catheter infections to be treated for 7 to 14 days. This represents a variability of up to 100%. No recommendations have been published regarding the duration of treatment of bacteremia from other sources. The objective of this project is to prove that the 7-day course of treatment for EB bacteremia is more efficient and equally safe than the 14-day scheme.

Detailed description

To achieve theses objectives, we propose this randomized, multicentric clinical trial with a superiority design on the duration of antimicrobial treatment for EB bacteremia in adult patients.

Conditions

• Enterobacteriaceae Infections
• Bloodstream Infection

Interventions

Type	Name	Description
OTHER	7 days course of antibiotic treatment	Standard antibiotic treatment approved for enterobacteraciae infections
OTHER	14 days course of antibiotic treatment	Standard antibiotic treatment approved for enterobacteraciae infections

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-02
• Completion: 2017-03-01
• First posted: 2015-03-27
• Last updated: 2017-03-13

Locations

4 sites across 1 country: Spain