PneumoniaPhase 3NCT01057758
STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia
A Phase 3 study testing SIMVASTATIN in people with Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- SIMVASTATIN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Jun 2013
- 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
- Duration of mechanical ventilation > 48 h
- First episode of suspicion of VAP with a Clinical Pulmonary Infection Score modified ≥ 5
- BAL, plugged telescopic catheter and/or tracheal aspirates quantitative cultures performed prior administration of antibiotics
- Informed consent
Who cannot join
- Statin treatment received under mechanical ventilation
- Age less than 18 years
- Pregnancy
- Unable to receive or unlikely to absorb enteral study drug
- Patient, surrogate, or physician not committed to full support ).
- Moribund patient with a SAPS II score > 75
- Simvastatin specific exclusions Allergy or intolerance to statins Physician insistence for the use or avoidance of statins during the current hospitalization CK , ALT or AST > 5 times the upper limit of normal Receiving cyclosporine, gemfibrozil, lopinavir, ritonavir itraconazole, kétoconazole, érythromycine, clarithromycine, télithromycine, néfazodone, verapamil, diltiazem
- Severe chronic liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia
The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.
Read the detailed description
When a patient will present a suspicion of VAP (Clinical Pulmonary Infection Score modified ≥ 5), Simvastatin or placebo will be administered with antibiotics. Quantitative cultures will be performed for microbiological confirmation of VAP. Simvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications will be determined by the patient's primary team. Study drug will be blinded with an identical appearing placebo.
Sequential Organ Failure Assessment score (SOFA), and various blood factors will be measured during treatment.
- Conditions
- Pneumonia
- Being tested
- SIMVASTATIN, PLACEBO
- Keywords
- Suspicion of ventilator-associated pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMVASTATINDrug
Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.
PLACEBODrug
Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Half of the patients will be randomized to the placebo Receives: Drug: PLACEBO |
| Simvastatin | Active comparator | Half of the subjects will receive the active drug, Simvastatin. Receives: Drug: SIMVASTATIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary efficacy measure is hospital mortality to day 28.
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2013
- Study completionJun 2013
Why it stopped: stopped for futility
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 PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT PAPAZIAN, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057758
- Sponsor's protocol ID
- 2008-002019-42
- Other IDs
- 2008 13, 2008
- Status last verified
- Apr 2013
- First submitted
- 26 Jan 2010
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Papazian L, Roch A, Charles PE, Penot-Ragon C, Perrin G, Roulier P, Goutorbe P, Lefrant JY, Wiramus S, Jung B, Perbet S, Hernu R, Nau A, Baldesi O, Allardet-Servent J, Baumstarck K, Jouve E, Moussa M, Hraiech S, Guervilly C, Forel JM; STATIN-VAP Study Group. Effect of statin therapy on mortality in patients with ventilator-associated pneumonia: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1692-700. doi: 10.1001/jama.2013.280031.
PubMed 24108510
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia
- ClinicalTrials.gov ID
- NCT01057758
- Acronym / sponsor ID
- 2008-002019-42
- Conditions
- Pneumonia
- Keywords
- Suspicion of ventilator-associated pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: stopped for futility
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Jan 2010 (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.
The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.
Detailed description
When a patient will present a suspicion of VAP (Clinical Pulmonary Infection Score modified ≥ 5), Simvastatin or placebo will be administered with antibiotics. Quantitative cultures will be performed for microbiological confirmation of VAP. Simvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications will be determined by the patient's primary team. Study drug will be blinded with an identical appearing placebo.
Sequential Organ Failure Assessment score (SOFA), and various blood factors will be measured during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: PLACEBOHalf of the patients will be randomized to the placebo |
| Simvastatin | Active comparator | Drug: SIMVASTATINHalf of the subjects will receive the active drug, Simvastatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Duration of mechanical ventilation > 48 h
- First episode of suspicion of VAP with a Clinical Pulmonary Infection Score modified ≥ 5
- BAL, plugged telescopic catheter and/or tracheal aspirates quantitative cultures performed prior administration of antibiotics
- Informed consent
Key exclusion criteria (8 listed)
- Statin treatment received under mechanical ventilation
- Age less than 18 years
- Pregnancy
- Unable to receive or unlikely to absorb enteral study drug
- Patient, surrogate, or physician not committed to full support ).
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 |
|---|---|---|
| SIMVASTATINPatients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU. | Drug | Simvastatin |
| PLACEBOPatients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU | Drug | PLACEBO |
Primary outcome
The Primary efficacy measure is hospital mortality to day 28.
Time frame: 28 days after randomization
Results and safety
The study was stopped early (reason given: stopped for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Derived from this study: PubMed 24108510Papazian L, Roch A, Charles PE, Penot-Ragon C, Perrin G, Roulier P, Goutorbe P, Lefrant JY, Wiramus S, Jung B, Perbet S, Hernu R, Nau A, Baldesi O, Allardet-Servent J, Baumstarck K, Jouve E, Moussa M, Hraiech S, Guervilly C, Forel JM; STATIN-VAP Study Group. Effect of statin therapy on mortality in patients with ventilator-associated pneumonia: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1692-700. doi: 10.1001/jama.2013.280031.
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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.
LAURENT PAPAZIAN principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIMVASTATIN in people with Pneumonia, run by Assistance Publique Hopitaux De Marseille at 1 site 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 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (reason given: stopped for futility). 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?
The Primary efficacy measure is hospital mortality to day 28. (time frame: 28 days after randomization). 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 NCT01057758, 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 30 Oct 2013.