Causes and Outcomes of Community Acquired Pneumonia (CAP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Oxford University Clinical Research Unit, Vietnam.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Oxford University Clinical Research Unit, Vietnam
Information provided by:
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01336036
First received: April 6, 2011
Last updated: April 13, 2011
Last verified: March 2011
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Purpose
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
| Condition |
|---|
|
Community Acquired Pneumonia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital |
Resource links provided by NLM:
Further study details as provided by Oxford University Clinical Research Unit, Vietnam:
Primary Outcome Measures:
- Proportion of patients who are stable at Day 3, 7 and 14 [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
• 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
Secondary Outcome Measures:
- Day 14 mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]Proportion of patients who die at Day 14
- Length of stay (days) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]Length of stay from admission to discharge in days
- Need for mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
- Length of ventilation time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Sputum Blood Urine Nasal and Throat swab
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
300 patients with community acquired pneumonia who meet the below inclusion/ exclusion criteria will be recruited at two hospitals in Vietnam.
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336036
Contacts
| Contact: Kinh V Nguyen, PhD | +844 35764305 | kinhvaac@yahoo.com |
Locations
| Vietnam | |
| National Hospital of Tropical Diseases | Recruiting |
| Hanoi, Vietnam | |
| Contact: Ngan D Ta, MD +844 35764305 ngantadieu@yahoo.com | |
| Principal Investigator: Kinh V Nguyen, PhD | |
| Sub-Investigator: Peter Horby, MD | |
| Sub-Investigator: Heiman Wertheim, PhD | |
| Sub-Investigator: Ha H Nguyen, MD | |
| Sub-Investigator: Trung V Nguyen, PhD | |
| Sub-Investigator: Trinh T Dao | |
| Nguyen Tri Phuong Hospital | Not yet recruiting |
| Ho Chi Minh, Vietnam | |
| Contact: Rogier van Doorn, MD | |
| Sub-Investigator: Van H Pham, MD | |
| Sub-Investigator: Dung T Le, MD | |
| Sub-Investigator: Rogier van Doorn, MD | |
Sponsors and Collaborators
Oxford University Clinical Research Unit, Vietnam
Investigators
| Principal Investigator: | Kinh V Nguyen, PhD | National Hospital of Tropical Diseases |
| Principal Investigator: | Peter Horby, Dr. | Oxford University Clinical Research Unit - Hanoi |
| Principal Investigator: | Rogier van Doorn, MD | Oxford University Clinical Research Unit |
More Information
Additional Information:
No publications provided
| Responsible Party: | Peter Horby, Principal Investigator, Oxford University Clinical Research Unit, Hanoi, Vietnam |
| ClinicalTrials.gov Identifier: | NCT01336036 History of Changes |
| Other Study ID Numbers: | 03HN |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 13, 2011 |
| Health Authority: | Vietnam: Ministry of Health |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013