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

Primary Purpose

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Colistin (Polymyxin E) 100mg x 4/d

both medications

will not receive PO treatment

PO Garamycin 80mg x 4/d

About this trial

This is an interventional treatment trial for Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia focused on measuring Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rambam Mc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group 1: will receive PO Garamycin 80mg x 4/d

Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d

Group 3: will receive both medications

Group 4: will not receive PO treatment

Arm Description

will receive PO Garamycin 80mg x 4/d

Outcomes

Primary Outcome Measures

The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).

- Is this outcome measure assessing a safety issue? Select: no

Secondary Outcome Measures

Full Information

NCT ID

NCT01266499

First Posted

December 23, 2010

Last Updated

April 26, 2017

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT01266499

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Keywords

Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: will receive PO Garamycin 80mg x 4/d

Arm Type

Active Comparator

Arm Description

will receive PO Garamycin 80mg x 4/d

Arm Title

Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d

Arm Type

Active Comparator

Arm Title

Group 3: will receive both medications

Arm Type

Active Comparator

Arm Title

Group 4: will not receive PO treatment

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Colistin (Polymyxin E) 100mg x 4/d

Intervention Description

Colistin (Polymyxin E) 100mg x 4/d

Intervention Type

Drug

Intervention Name(s)

both medications

Intervention Description

PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d

Intervention Type

Drug

Intervention Name(s)

will not receive PO treatment

Intervention Description

will not receive PO treatment - will receive plecebo treatment

Intervention Type

Drug

Intervention Name(s)

PO Garamycin 80mg x 4/d

Intervention Description

PO Garamycin 80mg x 4/d

Primary Outcome Measure Information:

Title

The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).

Description

- Is this outcome measure assessing a safety issue? Select: no

Time Frame

twice a week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inclusion Criteria Patient identified as a KPC carrier. Patient capable to understand and sign informed consent Age > 18 Patient capable to receive oral medication Exclusion Criteria: Exclusion Criteria: Patient unable to sign informed consent Age ≤ 18 Pregnant/lactating female Patient not expected to survive > 2 weeks. Patient unable or not allowed to receive oral medications A known allergy to study drugs.

Overall Study Officials: