SDD for Eradicating CRKP Carriage

NCT ID: NCT01761487

Last Updated: 2013-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31

Brief Summary

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.

Conditions

Carriers of Carbapenem-resistant Klebsiella Pneumonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

One arm only - Gentamicin and polymyxin E

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

Group Type: OTHER

Gentamicin and polymyxin E

Intervention Type: DEVICE

Interventions

Gentamicin and polymyxin E

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Soroka University Medical Center

Beersheba, Negev, Israel

Countries

Israel

Central Contacts

Lisa Saidel-Odes, MD

Role: CONTACT

saidelod@bgu.ac.il

972-8-6400370

Other Identifiers

0285-12

Identifier Type: -

Identifier Source: org_study_id