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.
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
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.
- Conditions
- Ventilator Associated Pneumonia
- 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 group | Role | What they receive |
|---|---|---|
| povidone iodine | Experimental | Povidone iodine Receives: Drug: povidone iodine |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ventilator associated pneumonia
Measured: 30 days
Secondary outcomes (12)
Time to ventilator associated pneumoniae
Measured: 30 days
Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae
Measured: 30 days
Length of mechanical ventilation
Measured: 30 days
Other infections
Measured: 30 days
Acute respiratory distress syndrome
Measured: 30 days
Treatments administered (antibiotics, sedatives, transfusion)
Measured: 30 days
Length of ICU and hospital stay
Measured: Hospital discharge
Death
Measured: ICU, 1 months, 3 months
Oropharyngeal bacterial colonisation
Measured: 30 days
Type of anesthetic agents received
Measured: 30 days
Rate of tracheostomy
Measured: 30 days
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.
- First posted31 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Seguin, MD, PhD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00950027
- Acronym / sponsor ID
- SPIRIT-ICU / EudraCT 2006-006353-27
- Conditions
- Ventilator Associated Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| povidone iodine | Experimental | Drug: povidone iodinePovidone iodine |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| povidone iodineoropharyngeal decontamination every 4 hours | Drug | povidone iodine |
| Placebooropharyngeal decontamination every 4 hours | Drug | placebo |
Primary outcome
Rate of ventilator associated pneumonia
Time frame: 30 days
12 secondary outcomes
Time to ventilator associated pneumoniae
Time frame: 30 days
Rate of early (<=7 days) and late (>7 days) ventilator associated pneumoniae
Time frame: 30 days
Length of mechanical ventilation
Time frame: 30 days
Other infections
Time frame: 30 days
Acute respiratory distress syndrome
Time frame: 30 days
Treatments administered (antibiotics, sedatives, transfusion)
Time frame: 30 days
Length of ICU and hospital stay
Time frame: Hospital discharge
Death
Time frame: ICU, 1 months, 3 months
Oropharyngeal bacterial colonisation
Time frame: 30 days
Type of anesthetic agents received
Time frame: 30 days
Rate of tracheostomy
Time frame: 30 days
Rate of transfusion (red blood cells, platelets, plasma)
Time frame: 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2012.
- Derived from this study: PubMed 24105456Seguin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Seguin, MD, PhD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
7 sites in 1 country: see every site and its status.
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.