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OpenTrials
Completed

NCT Number: NCT01266499

A 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.

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Key information

Conditions

Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Keratoconus posticus circumscriptus Klebsiella Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Mc

Haifa, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion Criteria
  • Patient identified as a KPC carrier.
  • Patient capable to understand and sign informed consent
  • Age > 18
  • Patient capable to receive oral medication

Exclusion criteria

  • Exclusion Criteria:
  • Patient unable to sign informed consent
  • Age ≤ 18
  • Pregnant/lactating female
  • Patient not expected to survive > 2 weeks.
  • Patient unable or not allowed to receive oral medications
  • A known allergy to study drugs.

Treatment and study plan

Colistin (Polymyxin E) 100mg x 4/d

Drug

Colistin (Polymyxin E) 100mg x 4/d

both medications

Drug

PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d

will not receive PO treatment

Drug

will not receive PO treatment - will receive plecebo treatment

PO Garamycin 80mg x 4/d

Drug

PO Garamycin 80mg x 4/d

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study 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).

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 24, 2010
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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