PneumoniaNCT02074033
Errors in Prescription Antibiotics in Ventilator-associated Pneumonia
An observational study of Pneumonia, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- Type of treatment
- Injection or infusion
- How many people
- 130 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Oct 2014
- Phase
- Observational
- 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
Study population: The study is a retrospective study to evaluate the use of antibiotics in the ventilator-associated pneumonia (PAV) in the Intensive Care Unit of the Adult Clinical Hospital of the Federal University of Uberlândia. The UnitAdult Intensive Care has complexity level III and consists of 30 beds.O number of statistically significant sample is 130 patients.
Who may be able to join
- Be 18 years of age;
- Having the diagnosis of ventilator-associated pneumonia.
Who cannot join
- Be under 18 years of age;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ana Carolina Souza Oliveira
Uberlândia, Minas Gerais, 38405322
Denise Von Dollinger de Brito
Ana Carolina Souza Oliveira
About this study
Official title: Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil
The infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.
Read the detailed description
In patients who had a diagnosis of ventilator-associated pneumonia by asssistente physician will be assessed initially prescribed antibiotics empirically and what conduct adopted after culture results.
We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) . The deescalation consists of discontinuing the use of antimicrobial or antibiotic change to another with lower coverage and spectrum is performed, escalation occurs when adding a new antibiotic or antibiotic to change the coverage of other larger spectrum after culture results .
- Conditions
- Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| antibiotics for pneumonia | We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Carolina Souza Oliveira, Federal University of Uberlandia
- Investigators
- Ana Carolina Souza Oliveira, Principal investigator, Federal University of UberlandiaDenise Von Dollinger de Brito, Principal investigator, Federal University of UberlandiaThúlio Marquez Cunha, Principal investigator, Federal University of UberlandiaFabiola Alves Gomes, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074033
- Sponsor's protocol ID
- 30121978
- Status last verified
- Mar 2014
- First submitted
- 23 Feb 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil
- ClinicalTrials.gov ID
- NCT02074033
- Acronym / sponsor ID
- 30121978
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 28 Feb 2014 (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 infection is a major risk to hospitalized patients, especially those admitted to the Intensive Care Unit (ICU) and an unfavorable factor in the outcome of critically ill patients, increasing costs and prolonging hospitalization hospitalar. The ventilator-associated pneumonia (PAV) is considered the most prevalent nosocomial infection in the ICU, occurring in 9% to 68% of patients with prosthetic ventilatória.Due to the high rate of PAV and mortality related to it, is very important both prescription and administration of antibiotics correctly, as deescalation or escalation according the result of cultures.Therefore, the objectives of this study is assess if whether the antibiotic prescribed of ventilator-associated pneumonia following the orientation of literature. Will also be assessed the rate of PAV in patients critically ill adults, the main microorganisms responsible by PAV and determining antimicrobial susceptibility.
Detailed description
In patients who had a diagnosis of ventilator-associated pneumonia by asssistente physician will be assessed initially prescribed antibiotics empirically and what conduct adopted after culture results.
We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) . The deescalation consists of discontinuing the use of antimicrobial or antibiotic change to another with lower coverage and spectrum is performed, escalation occurs when adding a new antibiotic or antibiotic to change the coverage of other larger spectrum after culture results .
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| antibiotics for pneumonia | – | –We will be examined whether the antibiotic prescribed following the orientation of literature, considering the dose, interval between doses, dose adjustment for renal failure infusion time, treatment time and conduct after the culture results (deescalation, escalation or maintenance of antimicrobial initially prescribed ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is a retrospective study to evaluate the use of antibiotics in the ventilator-associated pneumonia (PAV) in the Intensive Care Unit of the Adult Clinical Hospital of the Federal University of Uberlândia. The UnitAdult Intensive Care has complexity level III and consists of 30 beds.O number of statistically significant sample is 130 patients.
Key inclusion criteria (2 listed)
- Be 18 years of age;
- Having the diagnosis of ventilator-associated pneumonia.
Key exclusion criteria (1 listed)
- Be under 18 years of age;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Guidelines for the Management of Adults with Hospital-acquired, Ventilator-associated, and Healthcare-associated Pneumonia. American Journal of Respiratory and Critical Care Medicine, NewLink provided by the sponsor.
- ALVAREZ-LERMA, F. et al. Empiric broad-spectrum antibiotic therapy of nosocomial pneumonia in the intensive care unit: A prospective observational study. Crit Care, London, v.10, n.3, p.1-11, May 2006.Link provided by the sponsor.
- ANGUS, D.C.et al. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome and associa¬ted costs of care. Crit Care Med, New York, v.29, n.7, p.1303-1310, Jul 2001.Link provided by the sponsor.
- BURKE, J.P. Infection control- a problem for patient safety. N Engl J Med, Melbourn, v.348, n.7, p. 651-656, Feb 2003.Link provided by the sponsor.
- CAMARGO, L. F. A. et al. Ventilator associated pneumonia: comparison between quantitative and qualitative cultures of tracheal aspirates. Critical Care Medicine, New York, v.8, n.6, p. 422-430, Dec 2004.Link provided by the sponsor.
- EACHEMPATI, S.R. et al. Does de-escalation of antibiotic therapy for ventilator-associated pneumonia affect the likelihood of recurrent pneumonia or mortality in critically ill surgical patients? J Trauma, Baltimore, v.66, n.5, p.1343-1348, May 2009.Link provided by the sponsor.
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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.
Ana Carolina Souza Oliveira principal investigator
Federal University of Uberlandia
Denise Von Dollinger de Brito principal investigator
Federal University of Uberlandia
Thúlio Marquez Cunha principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Federal University of Uberlandia at 1 site in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Mar 2014. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Carolina Souza Oliveira (055343182150, acsouzao@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Errors in Prescription Antibiotics in Ventilator-associated Pneumonia in Unit of Intensive Care of Clinical Hospital of Federal University of Uberlandia - Brazil (time frame: six months). 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 27 Mar 2014.