Ventilator-Associated PneumoniaPhase 2NCT02704923
Atropine for Preventing Ventilator-Associated Pneumonia
A Phase 2 study testing Atropine in people with Ventilator-Associated Pneumonia, run by Universidade de Passo Fundo.
Trial summary
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia. 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?
- Atropine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2015
- Phase
- Phase 2
- 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
- Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours
Who cannot join
- Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape
About this study
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.
Read the detailed description
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.
- Conditions
- Ventilator-Associated Pneumonia
- Being tested
- Atropine, Placebo
- Keywords
- Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Also called Atropine eye drops
Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
PlaceboDrug
Also called Placebo eye drops
Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Atropine | Active comparator | Not described Receives: Drug: Atropine |
| 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.
Ventilator-Associated Pneumonia
Incidence of ventilator-associated pneumonia through the end of the study, an average of one year
Measured: through the end of the study, an average of one year
Secondary outcomes (1)
Death
Incidence of death through the end of the study, an average of one year
Measured: through the end of the study, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Associated PneumoniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cassiano Mateus Forcelini, Universidade de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704923
- Sponsor's protocol ID
- CAAE 40374815.3.0000.5342
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine for Preventing Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT02704923
- Acronym / sponsor ID
- CAAE 40374815.3.0000.5342
- Conditions
- Ventilator-Associated Pneumonia
- Keywords
- Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Mar 2016 (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.
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.
Detailed description
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.
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 |
|---|---|---|
| Atropine | Active comparator | Drug: Atropine |
| 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 (1 listed)
- Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours
Key exclusion criteria (1 listed)
- Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape
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 |
|---|---|---|
| AtropineAlso: Atropine eye dropsAtropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours | Drug | Atropine |
| PlaceboAlso: Placebo eye dropsPlacebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours | Drug | Placebo |
Primary outcome
Ventilator-Associated Pneumonia
Time frame: through the end of the study, an average of one year
Incidence of ventilator-associated pneumonia through the end of the study, an average of one year
1 secondary outcome
Death
Time frame: through the end of the study, an average of one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atropine in people with Ventilator-Associated Pneumonia, run by Universidade de Passo Fundo.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ventilator-Associated Pneumonia (time frame: through the end of the study, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2016.