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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).

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

Page last updated: August 23, 2015

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