A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
This trial is active, not recruiting.
|Condition||patients diagnosed with concomitant kpc associated disease ,bacteremia, pneumonia.|
|Treatments||colistin (polymyxin e) 100mg x 4/d, both medications, will not receive po treatment, po garamycin 80mg x 4/d|
|Sponsor||Rambam Health Care Campus|
|Start date||July 2009|
|End date||January 2011|
|Trial size||200 participants|
|Trial identifier||NCT01266499, KPCCTIL|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
time frame: twice a week
Male or female participants at least 18 years old.
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.
|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).|
|Principal investigator||Tsila Zuckerman, DR|
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