Enterobacteriaceae Producing Extended-spectrum β-lactamases (ESBL) Decolonization Study

Enterobacteriaceae Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826670
• Other study ID #: 08-161
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: August 6, 2012
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Multidrug-resistant Enterobacteriaceae producing extended-spectrum β-lactamases (hereafter called ESBLs) have emerged as an important cause of bloodstream infection in hospitalized patients and urinary tract infections in the community. As is the case with other multidrug-resistant organisms chronic colonization is frequent, in the case of ESBLs mostly intestinal and urinary carriage.

To the investigators knowledge no randomized, placebo-controlled clinical trial has been performed to study the efficacy of a systematic ESBL eradication strategy. Eradication of ESBL carriage would cause benefits for the individual patient - by reducing the risk of infection - and for the community - by reducing transmission. Even if eradication turns out to be impossible, transient suppression of ESBL might reduce the likelihood of transmission and thus still be beneficial from an ecologic perspective.

The purpose of the proposed study is to test the hypothesis that the administration of a 10 day course of oral antibiotics active against ESBLs can lead to decolonization of ESBL carriage in hospitalized patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients can be enrolled into the study provided that all of the following criteria are met:

1. Microbiologically documented rectal carriage of ESBL-producing Enterobacteriaceae, without signs and symptoms of active infection with ESBL-producing Enterobacteriaceae at any body site

2. Patient must give written informed consent to participate in the study. The informed consent can be given by the legal representative if necessary.

Exclusion Criteria:

1. Women who are pregnant or nursing

2. Active infection

3. Treatment with antimicrobial agents with activity against ESBL-producing Enterobacteriaceae

4. Contraindication to the use of one of the study drugs (e.g. renal insufficiency with creatinine clearance < 30 ml/min)

5. Patient already enrolled in another study, or in the present study for a previous episode

6. Psychiatric disorder or unable to understand or to follow the protocol directions

7. Permanent indwelling urinary catheter that can not be changed

8. Resistance of the ESBL-producing Enterobacteriaceae to one of the study drugs

9. Known hypersensitivity to one of the study drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterobacteriaceae Infections

Intervention

Drug:
• Decolonization
Colistin sulphate (50mg 4x/d PO) + Neomycin (250mg 4x/day PO) for 10 days plus In the presence of urinary tract colonization choice of one of the following agents (according to susceptibility profile, creatinine clearance and individual contraindications) Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days
• Placebo (Decolonization)
Placebo

Locations

Country	Name	City	State
Switzerland	Geneva Universits Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment		28 days	No