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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Rambam Health Care Campus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01266499
First received: December 23, 2010
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Patients Diagnosed With Concomitant KPC Associated Disease ,Bacteremia, Pneumonia.
Drug: Colistin (Polymyxin E) 100mg x 4/d
Drug: both medications
Drug: will not receive PO treatment
Drug: PO Garamycin 80mg x 4/d

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%). [ Time Frame: twice a week ] [ Designated as safety issue: No ]
    - Is this outcome measure assessing a safety issue? Select: no


Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: will receive PO Garamycin 80mg x 4/d
will receive PO Garamycin 80mg x 4/d
Drug: PO Garamycin 80mg x 4/d
PO Garamycin 80mg x 4/d
Active Comparator: Group 2 : will receive PO Colistin (Polymyxin E) 100mg x 4/d Drug: Colistin (Polymyxin E) 100mg x 4/d
Colistin (Polymyxin E) 100mg x 4/d
Active Comparator: Group 3: will receive both medications Drug: both medications
PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
Placebo Comparator: Group 4: will not receive PO treatment Drug: will not receive PO treatment
will not receive PO treatment - will receive plecebo treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266499

Locations
Israel
Rambam Mc
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Tsila Zuckerman, DR rambam mc
Principal Investigator: ILANA OREN, Dr Site Sub Investigator
Principal Investigator: Jacob M Rowe, Prof Site Sub-Investigator
Principal Investigator: RENATO FINKELSTEIN, Prof Site Sub-Investigator
Principal Investigator: Norberto Krivoy, Prof Site Sub-Investigator
Principal Investigator: HANA Shprecher, Dr Site Sub-Investigator
Principal Investigator: Noam Benyamini, Dr Site Sub-Investigator
Principal Investigator: Salim Hadad, Dr Site Sub-Investigator
Principal Investigator: Ami Neuberger, Dr Site Sub-Investigator
Principal Investigator: Eyal Braun, Dr Site Sub-Investigator
Principal Investigator: Ayelet Raz, Dr Site Sub-Investigator
  More Information

No publications provided

Responsible Party: Dr. Zuckerman- PI, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01266499     History of Changes
Other Study ID Numbers: KPCCTIL
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,

Additional relevant MeSH terms:
Bacteremia
Klebsiella Infections
Pneumonia
Bacterial Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Infection
Inflammation
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Sepsis
Systemic Inflammatory Response Syndrome
Colistin
Gentamicins
Polymyxins
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014