Community Acquired PneumoniaCAPNCT01336036
Causes and Outcomes of Community Acquired Pneumonia
An observational study of Community Acquired Pneumonia, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Vietnam.
Trial summary
This is a descriptive clinical research aiming: To describe the clinical spectrum and clinical characteristics of community acquired pneumonia (CAP) in patients admitted to hospital To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms To identify the risk factors that influence the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- How many people
- 300 participants
- Where
- 2 sitesVietnam
- Study dates
- Feb 2011to Feb 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: 300 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited at two hospitals in Vietnam.
Who may be able to join
- Patients > or = 18 years of age
- Patient meets the criteria of pneumonia (below), established within 36h of hospitalization
- Patient is not hospitalized or residing in a long-term-care facility within 14 days before the onset of symptoms
- Patient has not been at a referral hospital for >2 days before admission to the study hospital
- Informed consent to participate in the study is provided
Who cannot join
- Severe immunosuppression as judged by the enrolling physician (e.g. HIV, leukemia, lymphoma, chemotherapy for solid tumors, long-term corticosteroid use or other immunosuppressive drugs)
- Known active tuberculosis or current treatment for tuberculosis
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
National Hospital of Tropical Diseases
Hanoi, Hanoi
Nguyen Tri Phuong Hospital
Ho Chi Minh City
About this study
Official title: Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital
This is a descriptive clinical research aiming:
- To describe the clinical spectrum and clinical characteristics of community acquired pneumonia (CAP) in patients admitted to hospital
- To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms
- To identify the risk factors that influence the severity of CAP
Read the detailed description
In Vietnam, the range and relative contribution of organisms causing CAP remain unclear, largely because diagnostic tools are limited and clinical research uncommon. An improved understanding of the risk factors, etiology and clinical outcomes of CAP in Vietnam would contribute to improved approaches to patient diagnosis and clinical management. This will be achieved by following the clinical and laboratory progress and treatment outcomes of in-patients diagnosed with CAP from admission to discharge. Comparative analyses will be between subgroups including survivor and non-survivor, severe CAP and non-severe CAP, known etiology and unknown etiology, SIRS, sepsis, severe sepsis and shock septic.
- Conditions
- Community Acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are stable at Day 3, 7 and 14
- Criteria for clinical stability
- Temperature < or = 37.8oC
- Heart rate < or = 100 beats/min
- Respiratory rate < or = 24 breaths/min
- Systolic blood pressure > or = 90 mm Hg
- Arterial oxygen saturation > or = 90% or pO2 > or = 60 mm Hg on room air
- Ability to maintain oral intake
- Normal mental status
Measured: up to 14 days
Secondary outcomes (4)
Day 14 mortality
Proportion of patients who die at Day 14
Measured: 14 days
Length of stay (days)
Length of stay from admission to discharge in days
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Need for mechanical ventilation
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ventilation time
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kinh V Nguyen, PhD, Principal investigator, National Hospital of Tropical DiseasesPeter Horby, Dr., Principal investigator, Oxford University Clinical Research Unit - HanoiRogier van Doorn, MD, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336036
- Sponsor's protocol ID
- 03HN
- Acronym
- CAP
- Status last verified
- Sep 2016
- First submitted
- 6 Apr 2011
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital
- ClinicalTrials.gov ID
- NCT01336036
- Acronym / sponsor ID
- CAP / 03HN
- Conditions
- Community Acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Apr 2011 (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 is a descriptive clinical research aiming:
- To describe the clinical spectrum and clinical characteristics of community acquired pneumonia (CAP) in patients admitted to hospital
- To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms
- To identify the risk factors that influence the severity of CAP
Detailed description
In Vietnam, the range and relative contribution of organisms causing CAP remain unclear, largely because diagnostic tools are limited and clinical research uncommon. An improved understanding of the risk factors, etiology and clinical outcomes of CAP in Vietnam would contribute to improved approaches to patient diagnosis and clinical management. This will be achieved by following the clinical and laboratory progress and treatment outcomes of in-patients diagnosed with CAP from admission to discharge. Comparative analyses will be between subgroups including survivor and non-survivor, severe CAP and non-severe CAP, known etiology and unknown etiology, SIRS, sepsis, severe sepsis and shock septic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited at two hospitals in Vietnam.
Key inclusion criteria (5 listed)
- Patients > or = 18 years of age
- Patient meets the criteria of pneumonia (below), established within 36h of hospitalization
- Patient is not hospitalized or residing in a long-term-care facility within 14 days before the onset of symptoms
- Patient has not been at a referral hospital for >2 days before admission to the study hospital
- Informed consent to participate in the study is provided
Key exclusion criteria (2 listed)
- Severe immunosuppression as judged by the enrolling physician (e.g. HIV, leukemia, lymphoma, chemotherapy for solid tumors, long-term corticosteroid use or other immunosuppressive drugs)
- Known active tuberculosis or current treatment for tuberculosis
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
Proportion of patients who are stable at Day 3, 7 and 14
Time frame: up to 14 days
• Criteria for clinical stability * Temperature < or = 37.8oC * Heart rate < or = 100 beats/min * Respiratory rate < or = 24 breaths/min * Systolic blood pressure > or = 90 mm Hg * Arterial oxygen saturation > or = 90% or pO2 > or = 60 mm Hg on room air * Ability to maintain oral intake * Normal mental status
4 secondary outcomes
Day 14 mortality
Time frame: 14 days
Length of stay (days)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Need for mechanical ventilation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ventilation time
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 30 Sep 2016.
- OUCRU studies public siteLink 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.
Kinh V Nguyen, PhD principal investigator
National Hospital of Tropical Diseases
Peter Horby, Dr. principal investigator
Oxford University Clinical Research Unit - Hanoi
Rogier van Doorn, MD principal investigator
Oxford University Clinical Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia, run by Oxford University Clinical Research Unit, Vietnam at 2 sites in Vietnam.
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 5 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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.
What does the primary outcome measure?
Proportion of patients who are stable at Day 3, 7 and 14 (time frame: up to 14 days). 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 30 Sep 2016.