A Study Evaluating the Role of Oral Antibiotics in an Aim to Eradicate Carrier State of Carbapenem- Resistant Klebsiella Pneumonia (KPC).
Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patients Diagnosed With Concomitant KPC Associated Disease ,Bacteremia, Pneumonia.
Intervention: Colistin (Polymyxin E) 100mg x 4/d (Drug); both medications (Drug); will not receive PO treatment (Drug); PO Garamycin 80mg x 4/d (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Rambam Health Care Campus Official(s) and/or principal investigator(s): Tsila Zuckerman, DR, Principal Investigator, Affiliation: rambam mc ILANA OREN, Dr, Principal Investigator, Affiliation: Site Sub Investigator Jacob M Rowe, Prof, Principal Investigator, Affiliation: Site Sub-Investigator RENATO FINKELSTEIN, Prof, Principal Investigator, Affiliation: Site Sub-Investigator Norberto Krivoy, Prof, Principal Investigator, Affiliation: Site Sub-Investigator HANA Shprecher, Dr, Principal Investigator, Affiliation: Site Sub-Investigator Noam Benyamini, Dr, Principal Investigator, Affiliation: Site Sub-Investigator Salim Hadad, Dr, Principal Investigator, Affiliation: Site Sub-Investigator Ami Neuberger, Dr, Principal Investigator, Affiliation: Site Sub-Investigator Eyal Braun, Dr, Principal Investigator, Affiliation: Site Sub-Investigator Ayelet Raz, Dr, Principal Investigator, Affiliation: Site Sub-Investigator
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Rambam Mc, Haifa, Israel
Additional Information
Starting date: July 2009
Last updated: December 23, 2010
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