NCT00950027

Brief Summary

Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

3.4 years

First QC Date

July 30, 2009

Last Update Submit

July 4, 2012

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Rate of ventilator associated pneumonia

    30 days

Secondary Outcomes (12)

  • Time to ventilator associated pneumoniae

    30 days

  • Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae

    30 days

  • Length of mechanical ventilation

    30 days

  • Other infections

    30 days

  • Acute respiratory distress syndrome

    30 days

  • +7 more secondary outcomes

Study Arms (2)

povidone iodine

EXPERIMENTAL

Povidone iodine

Drug: povidone iodine

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

povidone iodineDRUG

oropharyngeal decontamination every 4 hours

povidone iodine
PlaceboDRUG

oropharyngeal decontamination every 4 hours

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> 18 years
  • Closed head trauma with a Glasgow Coma Score \<=8 or cerebral Hemorrhage with a Glasgow Coma Score of \<=8
  • Expected need mechanical ventilation for \>=2 days

You may not qualify if:

  • Impossibility to perform oropharyngeal decontamination within 12 h following the initial episode
  • Facial injury with impossibility to perform the oropharyngeal decontamination
  • Tetraplegia
  • Known history of reaction to iodine
  • Need for curative antibiotics
  • Mercurial antiseptics treatment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU Angers

Angers, France

Location

RĂ©animation chirurgical Hopital Hotel Dieu-CHU de Nantes

Nantes, France

Location

CHU de Poitiers

Poitiers, France

Location

Surgical Intensive Care Unit - CHU de Rennes

Rennes, France

Location

CHU de Rouen

Rouen, France

Location

RĂ©animation chirurgicale CHU Tours

Tours, France

Location

CHG Vannes

Vannes, France

Location

Related Publications (1)

  • Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRea Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.

    PMID: 24105456DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Philippe Seguin, MD, PhD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Bruno Laviolle, MD

    Rennes University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

April 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

FR(7)