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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).

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01266499
Enrollment
200
Registered
2010-12-24
Start date
2009-07-31
Completion date
2012-01-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Keywords

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

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.

Interventions

DRUGColistin (Polymyxin E) 100mg x 4/d

Colistin (Polymyxin E) 100mg x 4/d

DRUGboth medications

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

DRUGwill not receive PO treatment

will not receive PO treatment - will receive plecebo treatment

DRUGPO Garamycin 80mg x 4/d

PO Garamycin 80mg x 4/d

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026