PneumoniaNCT01250691
Effects of Isolated Rooms on the Prevalence of Hospital Acquired Pneumonia in a Respiratory ICU
An observational study of Pneumonia and Intensive Care Unit, run by Eskisehir Osmangazi University at 3 sites in Turkey (Türkiye).
Trial summary
This study will carry out in the ICU. Objectives of the study are to determine the frequency of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Intensive Care Unit
- What is being tested?
- ward-type ICU
- How many people
- 532 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- Jan 2004to Aug 2010
- 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: All of the patients who had been admitted to the ICU during this period were included in the study
Who may be able to join
- adult patients,
- admitted to the ICU
Who cannot join
- trauma, surgery or burned patients
- patients under 18
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Eskisehir Osmangazi University
Eskişehir, Merkez, 26040
Osmangazi University
Eskişehir, Merkez, 26040
Eskisehir Osmangazi University
Eskişehir, 26040
About this study
Official title: Epidemiologic Study of Hospital Acquired Pneumonia in a Respiratory ICU
This study will carry out in the ICU. Objectives of the study are to determine the frequency of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.
Read the detailed description
In the present study, it was aimed to determine the incidence, causative agents, antimicrobial resistance, and risk factors for lower respiratory tract infections in patients followed in the ICU for the last 4 years. The effect of reconfiguration from a ward-type ICU consisting one large room to an ICU with isolated rooms with two beds on the incidence of HAP was also determined.
- Conditions
- Pneumonia, Intensive Care Unit
- Being tested
- ward-type ICU
- Keywords
- pneumonia, ICU, isolation room, clinical epidemiology, infection control
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ward-type ICUOther
Also called frequency of hospital acquired pneumonia in the ICU
frequency of hospital acquired pneumonia in the ICU
| Study group | Role | What they receive |
|---|---|---|
| hospital acquired pneumonia | Not described | |
| isolated rooms | Not described Receives: Other: ward-type ICU | |
| ward-type ICU | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJan 2004
- Primary completionJul 2008
- Study completionAug 2010
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 532 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Investigators
- Irfan Ucgun, As.Prof.Dr., Study chair, Eskisehir Osmangazi University, Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250691
- Sponsor's protocol ID
- HAP-OU-isolation
- Status last verified
- Jan 2004
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Hospital Acquired Pneumonia in a Respiratory ICU
- ClinicalTrials.gov ID
- NCT01250691
- Acronym / sponsor ID
- HAP-OU-isolation
- Conditions
- Pneumonia, Intensive Care Unit
- Keywords
- pneumonia, ICU, isolation room, clinical epidemiology, infection control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 532 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Dec 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.
This study will carry out in the ICU. Objectives of the study are to determine the frequency of HAP and the effect of isolated rooms on the frequency of pneumonia in the ICU.
Detailed description
In the present study, it was aimed to determine the incidence, causative agents, antimicrobial resistance, and risk factors for lower respiratory tract infections in patients followed in the ICU for the last 4 years. The effect of reconfiguration from a ward-type ICU consisting one large room to an ICU with isolated rooms with two beds on the incidence of HAP was also determined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hospital acquired pneumonia | – | – |
| isolated rooms | – | Other: ward-type ICU |
| ward-type ICU | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All of the patients who had been admitted to the ICU during this period were included in the study
Key inclusion criteria (2 listed)
- adult patients,
- admitted to the ICU
Key exclusion criteria (2 listed)
- trauma, surgery or burned patients
- patients under 18
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 |
|---|---|---|
| ward-type ICUAlso: frequency of hospital acquired pneumonia in the ICUfrequency of hospital acquired pneumonia in the ICU | Other | isolated rooms |
Primary outcome
Not reported in the source record.
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 1 Dec 2010.
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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.
Irfan Ucgun, As.Prof.Dr. study chair
Eskisehir Osmangazi University, Medical Faculty
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Intensive Care Unit, run by Eskisehir Osmangazi University at 3 sites in Turkey (Türkiye).
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 2 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). 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?
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.
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 1 Dec 2010.