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

NCT02400268 | Completed Phase 3

• 1 other identifier: SHORTEN
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 4

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.

Conditions

Enterobacteriaceae Infections; Bloodstream Infection

Keywords

Enterobacteriaceae; Bloodstream; Bacteremia; Recurrence; Reinfection

Outcome Measures

Primary Outcomes (1)

• Days of antimicrobial treatment

  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.

  28 days

Secondary Outcomes (3)

• Adverse reactions related to antimicrobial treatment

  28 days

• Cure of bacteremia

  28 days

• Procalcitonin levels

  7-days and 14-days

Study Arms (2)

7 days course of antibiotic treatment

EXPERIMENTAL

Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.

Other: 7 days course of antibiotic treatment

14 days course of antibiotic treatment

ACTIVE COMPARATOR

Accepted antibiotic indicated for enterobacteriaceae infections, according to sensibility test performed and daily practice protocols or local guidelines.

Other: 14 days course of antibiotic treatment

Interventions

7 days course of antibiotic treatment OTHER

Standard antibiotic treatment approved for enterobacteraciae infections

Also known as: Antibiotics with approved indication

7 days course of antibiotic treatment

14 days course of antibiotic treatment OTHER

Standard antibiotic treatment approved for enterobacteraciae infections

Also known as: Antibiotics with approved indication

14 days course of antibiotic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Post-chemotherapy neutropenia expected to persist more than 7 days.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (4)

University Hospital Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Universitary Hospital Málaga

Málaga, Málaga, 29010, Spain

Location

University Hospital Virgen Macarena

Seville, Seville, 41007, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Seville, 41013, Spain

Location

Related Links

• This organization is formed by 16 Spanish leading research groups in the field, is public funded by Spanish Carlos III Institute and co-financed by European Development Regional Fund (ERDF)

MeSH Terms

Conditions

Enterobacteriaceae Infections; Sepsis; Bacteremia; Recurrence; Reinfection

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Jose Molina Gil-Bermejo, MD. PhD

  Hospitales Universitarios Virgen del Rocío

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: March 27, 2015
• Study Start: September 1, 2014
• Primary Completion: December 2, 2016
• Study Completion: March 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (4)