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

Phase 3

Completed

• Conditions: Enterobacteriaceae Infections; Bloodstream Infection
• Interventions: Other: 7 days course of antibiotic treatment; Other: 14 days course of antibiotic treatment

• Registration Number: NCT02400268
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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.

Study Timeline

• Study First Submitted: 2014-08-05
• Study Start: 2014-09
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-27
• Primary Completion: 2016-12-02
• Status Verified: 2017-03
• Study Completion: 2017-03-01
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

• Pregnancy
• Post-chemotherapy neutropenia expected to persist more than 7 days.
• Source of bacteremia uncontrolled at inclusion period or in the following 24 hours. The source will be considered as uncontrolled if the bacteremia is secondary to a suppurative infection potentially removable, if no action has been taken to eradicate it, including: bacteremia by vascular not removed catheter, cholangitis secondary to not derived obstruction of the biliary tract, deep abscess not drained, pyohydronephrosis without derivation of the urinary tract.
• Bacteremia secondary to infective endocarditis, bone and joint infections, or neurosurgical infections, which may require prolonged antimicrobial therapy
• Bacteremia due to enterobacteriaceae resistant to carbapenemics.
• Polymicrobial bacteremia including microorganisms different to enterobacteriaceae.
• Patients with no expectations of survival in the next 48 hours of inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7 days course of antibiotic treatment	7 days course of antibiotic treatment	Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.
14 days course of antibiotic treatment	14 days course of antibiotic treatment	Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.

Primary Outcome Measures

Name	Time	Method
Days of antimicrobial treatment	28 days	To prove that 7-days course of antibiotic therapy is more efficient than 14-days course when treating Enterobacteriaceae bacteremia, in terms of number of days at the end of follow up.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions related to antimicrobial treatment	28 days	To prove that 7-days course of antibiotic therapy is as safe as a 14-days course in terms of : Rate of adverse effects including: adverse reactions to drugs, superinfections by resistant bacteria or diarrhea by Clostridium difficile, mortality, relapse of the infection
Cure of bacteremia	28 days	Clinical and microbiological cure
Procalcitonin levels	7-days and 14-days	To analyze the utility of procalcitonin as a biomarker to decide the end of the antimicrobial treatment of Enterobacteriaceae bacteremia

Trial Locations

Locations (4)

University Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

University Hospital Virgen Macarena; 🇪🇸 Seville, Spain

Universitary Hospital Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Seville, Spain