Selective Digestive Decontamination in Carriers of Carbapenem-resistant Klebsiella Pneumoniae

Soroka University Medical Center

Status: Completed

Conditions: Carriage of Carbapemen-resistant Klebsialle Pneumoniae

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00753558

sor475808CTIL

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

Oral solution of 0.45% saline and oral solution of H2O \& saccharine. Oral gel composed of mineral oil, gelatine powder, pectin, sodium carboxymethylcellulose, polyethylene

Treatment:

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

1

Active Comparator group

Description:

Oral solution and buccal gel of gentamicin and polymyxin E

Treatment:

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