Clinical trial NCT02400268: Antibiotic Treatment Duration (7 vs 14 Days) Comparison in Blood Stream Infection Causes by Enterobacteriaceae
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Enterobacteriaceae Infections
Bloodstream Infection
Keywords: Enterobacteriaceae
Bloodstream
Bacteremia
Recurrence
Reinfection
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Adults patients (equal or over 18 years old)
* Primary or secondary bloodstream infection produced by enterobacteriaceae
* Source of bacteremia properly controlled or expect to be properly controlled in the next 24 hours (i.e. bacteremia produced by infected vascular catheter, abscess, obstruction of the biliary or urinary tract).
* Patients able to understand the objectives of the clinical trial and informed consent signed.

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.

Primary outcomes:
measure: Days of antimicrobial treatment
timeFrame: 28 days
Secondary outcomes:
measure: Adverse reactions related to antimicrobial treatment
timeFrame: 28 days
measure: Cure of bacteremia
timeFrame: 28 days
measure: Procalcitonin levels
timeFrame: 7-days and 14-days
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: University Hospital Reina Sofía
city: Málaga
country: Spain
facility: Universitary Hospital Málaga
city: Seville
country: Spain
facility: University Hospital Virgen Macarena
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Jose Molina Gil-Bermejo, MD. PhD
role: STUDY_DIRECTOR
References: