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

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Completed
• CT.gov ID: NCT00826670
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Enterobacteriaceae Infections	Drug: Decolonization; Drug: Placebo (Decolonization)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical decolonization	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 Comparator: Placebo	Drug: Placebo (Decolonization); Placebo

Outcome Measures

Primary Outcome Measures

1. Rate of eradication of carriage with ESBL-producing Enterobacteriaceae at day 28 post-treatment [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geneva Universits Hospitals	Geneva		Switzerland	1211

Sponsors and Collaborators

• University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stephen Harbarth, Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection, University Hospital, Geneva
• ClinicalTrials.gov Identifier: NCT00826670
• Other Study ID Numbers: 08-161
• First Posted: Jan 22, 2009
• Last Update Posted: Aug 7, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Stephen Harbarth, Médecin adjoint agrégé, Service Prévention et Contrô- le de l'Infection, University Hospital, Geneva: Antibiotic resistance; ESBL carriage
• Additional relevant MeSH terms: Enterobacteriaceae Infections

Study Results

No Results Posted as of Aug 7, 2012