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Completed

NCT Number: NCT00753558

Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

There is an urgent need to control our current national outbreak of carbapenem-resistant Klebsiella pneumoniae (CRKP). The purpose of this study is to eradicate CRKP gastrointestinal carriage using selective digestive decontamination (SDD); with buccal and oral gentamicin and polymyxin E administration. This will reduce infections and hopefully mortality caused by CRKP.

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Key information

Conditions

Carriage of Carbapemen-resistant Klebsialle Pneumoniae

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka University Medical Center

Beersheba, 84101, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized men and women with a positive rectal swab for CRKP
  • Age 18 years or older

Exclusion criteria

  • Age less than 18 years
  • Pregnant women, lactating women
  • A known allergy to the study drugs

Treatment and study plan

Arm #1 :Oral solution and buccal gel of gentamicin and polymyxin E. Arm #2: Placebo.

Drug

Arm #1: Oral gentamicin & polymyxin E, gentamicin & polymyxin E buccal gel.

Arm #2: Oral placebo solutions, placebo buccal gel.

Primary outcomes

  1. Eradication of CRKP carriage measured by negative rectal swabs

    Time frame: Two days after treatment ends

Secondary outcomes

  1. No new in-hospital acquisition of CRKP

    Time frame: Six weeks

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

A Randomized,Double-Blind,Placebo-Controled Trial of Selective Digestive Decontamination Using Oral Gentamicin and Oral Polymyxin E for Eradication of Carbapenem-Resistant Klebsiella Pneumoniae Carriage

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2008
Registry last updated
Sep 21, 2010

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.