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Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)

Primary Purpose

Nosocomial Infection, Respiratory Tract Infection, Surgical Site Infection

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Chlorhexidine gluconate (drug) vs placebo
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring Nosocomial infection,, Decontamination,, Randomized placebo-controlled trial,, Cardiac surgery,, Chlorhexidine,, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery Exclusion Criteria: emergency procedures, a preoperative infection and/or the use of antibiotics, hypersensitivity to chlorhexidine gluconate (CHX), absence of written informed consent or presence of an alternative prophylactic regimen like selective decontamination of the digestive tract

Sites / Locations

  • Onze lieve vrouwe gasthuis

Outcomes

Primary Outcome Measures

Nosocomial Infection

Secondary Outcome Measures

Respiratory tract and surgical site infection; S. aureus nasal carriage, nonprophylactic antibiotic use, hospital stay, in-hospital mortality, optimal duration of preoperative trial medication and medication adverse-effects.

Full Information

First Posted
January 4, 2006
Last Updated
January 6, 2006
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Onze Lieve Vrouwe Gasthuis
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1. Study Identification

Unique Protocol Identification Number
NCT00272675
Brief Title
Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)
Official Title
Prevention of Nosocomial Infection in Cardiac Surgery by Decontamination of the Naso- and Oropharynx With Chlorhexidine. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Onze Lieve Vrouwe Gasthuis

4. Oversight

5. Study Description

Brief Summary
Does chlorhexidine gluonate, a simple broad-spectrum antimicrobial agent with virtually no adverse-effects lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI?
Detailed Description
Nosocomial infections (NIs) after open heart surgery are recognized as an important cause of morbidity and mortality with a prolonged hospital stay, increased need for of antibiotics, decreased quality of life and higher concomitant costs. Decontamination of the oropharynx seems important, since there is direct evidence of an association between pulmonary infection and oral health. Another important strategy involves the eradication of Staphylococcus aureus, the most important pathogen causing SSI. The most common reservoir of S.aureus is the anterior nares and eradication can be achieved by the application of topical antibiotics. Although promising results have been reported for both strategies, they are not widely used as routine prevention methods because of the variability of trial design, the concern about the emergence of antimicrobial resistance and increased costs. Further research is essential to evaluate different protocols, antimicrobial agents and cost-effectiveness. Fur this purpose, we designed a clinical trial to study wether a simple broad-spectrum antimicrobial agent with virtually no adverse-effects would lower the incidence of NI after cardiac surgery, especially with respect to LTI and SSI. Comparison(s): Oropharyngeal and nasal decontamination with chlorhexidine compared to placebo in patients after cardiothoracic surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection, Respiratory Tract Infection, Surgical Site Infection
Keywords
Nosocomial infection,, Decontamination,, Randomized placebo-controlled trial,, Cardiac surgery,, Chlorhexidine,, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate (drug) vs placebo
Primary Outcome Measure Information:
Title
Nosocomial Infection
Secondary Outcome Measure Information:
Title
Respiratory tract and surgical site infection; S. aureus nasal carriage, nonprophylactic antibiotic use, hospital stay, in-hospital mortality, optimal duration of preoperative trial medication and medication adverse-effects.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery Exclusion Criteria: emergency procedures, a preoperative infection and/or the use of antibiotics, hypersensitivity to chlorhexidine gluconate (CHX), absence of written informed consent or presence of an alternative prophylactic regimen like selective decontamination of the digestive tract
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrique Segers, Drs.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze lieve vrouwe gasthuis
City
Amsterdam
ZIP/Postal Code
1090 HM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18461895
Citation
Segers P, Speekenbrink RG, Ubbink DT, van Ogtrop ML, de Mol BA. [Prevention of nosocomial infections after cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine; a prospective, randomised study]. Ned Tijdschr Geneeskd. 2008 Mar 29;152(13):760-7. Dutch.
Results Reference
derived
PubMed Identifier
17119142
Citation
Segers P, Speekenbrink RG, Ubbink DT, van Ogtrop ML, de Mol BA. Prevention of nosocomial infection in cardiac surgery by decontamination of the nasopharynx and oropharynx with chlorhexidine gluconate: a randomized controlled trial. JAMA. 2006 Nov 22;296(20):2460-6. doi: 10.1001/jama.296.20.2460.
Results Reference
derived

Learn more about this trial

Prevention of Nosocomial Infection by Decontamination of the Naso- and Oropharynx With Chlorhexidine (NONI Trial)

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