Clinical trial NCT01336036: Causes and Outcomes of Community Acquired Pneumonia
Official title: Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Lead sponsor: Oxford University Clinical Research Unit, Vietnam
Sponsor class: OTHER
First posted: 2011-04-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients who are stable at Day 3, 7 and 14
timeFrame: up to 14 days
Secondary outcomes:
measure: Day 14 mortality
timeFrame: 14 days
measure: Length of stay (days)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Need for mechanical ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Length of ventilation time
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital of Tropical Diseases
city: Ho Chi Minh
country: Vietnam
facility: Nguyen Tri Phuong Hospital
Study officials:
affiliation: National Hospital of Tropical Diseases
name: Kinh V Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Clinical Research Unit - Hanoi
name: Peter Horby, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Clinical Research Unit
name: Rogier van Doorn, MD
role: PRINCIPAL_INVESTIGATOR
References: