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

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

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.

Study Overview

• Status: Completed
• Conditions: Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
• Intervention / Treatment: Drug: PO Garamycin 80mg x 4/d; Drug: Colistin (Polymyxin E) 100mg x 4/d; Drug: both medications; Drug: will not receive PO treatment

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The specific measure that will be used to determine the effect of the intervention(s): eradication rate (%).	- Is this outcome measure assessing a safety issue? Select: no	twice a week

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant Klebsiella (KPC), eradication,
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Enterobacteriaceae Infections; Pneumonia; Bacteremia; Klebsiella Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins; Colistin; Polymyxins
• Other Study ID Numbers: KPCCTIL