SDD for Eradicating CRKP Carriage

Soroka University Medical Center

Status and phase: Unknown; Phase 4

Conditions: Carriers of Carbapenem-resistant Klebsiella Pneumonia

Treatments: Device: Gentamicin and polymyxin E

Study type: Interventional

Funder types: Other

Identifiers

NCT01761487

0285-12

Details and patient eligibility

About

There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).

In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.

The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
• Hospitalized men or women at least 18 years of age
• Rectal swab culture positive for CRKP in the last week
• Will be willing to initiate and remain on treatment, except for adverse events occurring

Exclusion criteria

• Age less than 18 years.
• Pregnant women, lactating women.
• A know allergy to one of the study drugs.
• Renal failure with creatinine clearance less than 50mL/min.
• Current Treatment with IV gentamicin and/or IV polymyxin E
• Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Trial design

100 participants in 1 patient group

One arm only - Gentamicin and polymyxin E

Other group

Description:

All subjects will receive:Gentamicin and polymyxin E paste applied on buccal surface four times daily + gentamicin + polymyxin E PO + Strict contact precautions

Treatment:

Device: Gentamicin and polymyxin E