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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
will receive PO Garamycin 80mg x 4/d
po garamycin 80mg x 4/d
PO Garamycin 80mg x 4/d
(Active Comparator)
colistin (polymyxin e) 100mg x 4/d
Colistin (Polymyxin E) 100mg x 4/d
(Active Comparator)
both medications
PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
(Placebo Comparator)
will not receive po treatment
will not receive PO treatment - will receive plecebo treatment

Primary Outcomes

The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).
time frame: twice a week

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Rambam Health Care Campus.