A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).

Not Applicable

Completed

• Conditions: Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
• Interventions: Drug: PO Garamycin 80mg x 4/d; Drug: Colistin (Polymyxin E) 100mg x 4/d; Drug: both medications; Drug: will not receive PO treatment

• Registration Number: NCT01266499
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. It is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3).

The aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the KPC carrier state.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Primary Completion: 2011-01
• Study Completion: 2012-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Inclusion Criteria

  1. Patient identified as a KPC carrier.
  2. Patient capable to understand and sign informed consent
  3. Age > 18
  4. Patient capable to receive oral medication

Exclusion Criteria

• Exclusion Criteria:

  1. Patient unable to sign informed consent
  2. Age ≤ 18
  3. Pregnant/lactating female
  4. Patient not expected to survive > 2 weeks.
  5. Patient unable or not allowed to receive oral medications
  6. A known allergy to study drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: will receive PO Garamycin 80mg x 4/d	PO Garamycin 80mg x 4/d	will receive PO Garamycin 80mg x 4/d
Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d	Colistin (Polymyxin E) 100mg x 4/d	-
Group 3: will receive both medications	both medications	-
Group 4: will not receive PO treatment	will not receive PO treatment	-

Primary Outcome Measures

Name	Time	Method
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).	twice a week	- Is this outcome measure assessing a safety issue? Select: no

Trial Locations

Locations (1)

Rambam Mc; 🇮🇱 Haifa, Israel