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Ventilator Associated PneumoniaPhase 3SPIRIT-ICUNCT00950027

Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage in Intensive Care Unit

A Phase 3 study testing povidone iodine in people with Ventilator Associated Pneumonia, run by Rennes University Hospital at 7 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventilator Associated Pneumonia
What is being tested?
povidone iodine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
179 participants
Where
7 sitesFrance
Study dates
Apr 2008to Sep 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Written informed consent from the patient's next-of-kin. If no relative is present at the time of inclusion, the patients will be included according to the emergency procedure

Who cannot join

  • 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
  • Respiratory disease or pulmonary infiltrate(s) at inclusion
  • Need for curative antibiotics
  • Mercurial antiseptics treatment
  • Pregnancy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CHU Angers

    Angers

  • Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes

    Nantes

  • CHU de Poitiers

    Poitiers

  • Surgical Intensive Care Unit - CHU de Rennes

    Rennes

  • CHU de Rouen

    Rouen

  • Réanimation chirurgicale CHU Tours

    Tours

  • CHG Vannes

    Vannes

Other trials in France

About this study

Official title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage

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.

Being tested
povidone iodine, Placebo
Medical subject headings
Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • povidone iodineDrug

    oropharyngeal decontamination every 4 hours

  • PlaceboDrug

    oropharyngeal decontamination every 4 hours

Study groups in NCT00950027
Study groupRoleWhat they receive
povidone iodineExperimentalPovidone iodine
Receives: Drug: povidone iodine
placeboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of ventilator associated pneumonia

    Measured: 30 days

Secondary outcomes (12)

  1. Time to ventilator associated pneumoniae

    Measured: 30 days

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

    Measured: 30 days

  3. Length of mechanical ventilation

    Measured: 30 days

  4. Other infections

    Measured: 30 days

  5. Acute respiratory distress syndrome

    Measured: 30 days

  6. Treatments administered (antibiotics, sedatives, transfusion)

    Measured: 30 days

  7. Length of ICU and hospital stay

    Measured: Hospital discharge

  8. Death

    Measured: ICU, 1 months, 3 months

  9. Oropharyngeal bacterial colonisation

    Measured: 30 days

  10. Type of anesthetic agents received

    Measured: 30 days

  11. Rate of tracheostomy

    Measured: 30 days

  12. Rate of transfusion (red blood cells, platelets, plasma)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2009 (estimated)
  2. Study startApr 2008
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
179 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00950027
Sponsor's protocol ID
EudraCT 2006-006353-27
Other IDs
AFSSAPS A70642-35, Sponsor PHRC/06-05 SPIRIT ICU
Acronym
SPIRIT-ICU
Status last verified
Jul 2012
First submitted
30 Jul 2009
Last updated
6 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24105456

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing povidone iodine in people with Ventilator Associated Pneumonia, run by Rennes University Hospital at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of ventilator associated pneumonia (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00950027, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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