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

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266499
• Other study ID #: KPCCTIL
• Status: Completed
• Phase: N/A
• First received: December 23, 2010
• Last updated: April 26, 2017
• Start date: July 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Klebsiella Infections
• Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia
• Pneumonia

Intervention

Drug:
• Colistin (Polymyxin E) 100mg x 4/d
Colistin (Polymyxin E) 100mg x 4/d
• both medications
PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
• will not receive PO treatment
will not receive PO treatment - will receive plecebo treatment
• PO Garamycin 80mg x 4/d
PO Garamycin 80mg x 4/d

Locations

Country	Name	City	State
Israel	Rambam Mc	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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