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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).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rambam68, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01266499
First received: December 23, 2010
Last updated: April 26, 2017
Last verified: April 2017
  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
Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or 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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]
    - Is this outcome measure assessing a safety issue? Select: no


Enrollment: 200
Study Start Date: July 2009
Study Completion Date: January 2012
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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
1. Center for Disease control and prevention. National Nosocomial Infections Surveillance 9NNIS0 System report, data summary from January 1992 through June 2003. Am J Infect Control 2003:31:481-98 2. Woodford N, Tierno PM Jr, Young K, Tysall L, Palepou MF, Ward E, Painter RE, Suber DF, Shungu D, Silver LL, Inglima K, Kornblum J, Livermore DM. Antimicrobial Agents Chemother. Outbreak of Klebsiella pneumonia producing a new carbapenem-hydrolyzing class a beta-lactamase, KPC-3, in a New York Medical Center.2004;48(12):4793-9. 3. Bradford PA, Bratu S, Urban C, Visalli M, Mariano N, Landman D, Rahal JJ, Brooks S, Cebular S, Quale J Emergence of carbapenem-resistant Klebsiella species possessing the class A carbapenem-hydrolyzing KPC-2 and inhibitor-resistant TEM-30 beta-lactamases in New York City. Clin Infect Dis. 2004 1;39(1):55-60.

Responsible Party: rambam68, prof, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01266499     History of Changes
Other Study ID Numbers: KPCCTIL
Study First Received: December 23, 2010
Last Updated: April 26, 2017

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

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

ClinicalTrials.gov processed this record on May 24, 2017