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

NCT00272675 | Completed Phase 2

• 1 other identifier: WO-03.021
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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?

Conditions

Nosocomial Infection; Respiratory Tract Infection; Surgical Site Infection

Keywords

Nosocomial infection,; Decontamination,; Randomized placebo-controlled trial,; Cardiac surgery,; Chlorhexidine,; Prevention

Outcome Measures

Primary Outcomes (1)

• Nosocomial Infection

Secondary Outcomes (1)

• 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.

Interventions

Chlorhexidine gluconate (drug) vs placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all adult patients (above 18) who were scheduled to undergo sternotomy for cardiothoracic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Onze Lieve Vrouwe Gasthuis: collaborator

Study Sites (1)

Onze lieve vrouwe gasthuis

Amsterdam, 1090 HM, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 18461895 DERIVED

• 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.

  PMID: 17119142 DERIVED

MeSH Terms

Conditions

Cross Infection; Respiratory Tract Infections; Surgical Wound Infection

Interventions

chlorhexidine gluconate; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Wound Infection; Postoperative Complications

Study Officials

• Patrique Segers, Drs.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 9, 2006
• Study Start: August 1, 2003
• Study Completion: September 1, 2005
• Last Updated: January 9, 2006

Record last verified: 2006-01

Locations

NL (1)