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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

will receive PO Garamycin 80mg x 4/d

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Colistin (Polymyxin E) 100mg x 4/d

Intervention Type DRUG

both medications

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

Intervention Type DRUG

will not receive PO treatment

will not receive PO treatment - will receive plecebo treatment

Intervention Type DRUG

PO Garamycin 80mg x 4/d

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No