Causes and Outcomes of Community Acquired Pneumonia

Completed

• Conditions: Community Acquired Pneumonia

• Registration Number: NCT01336036
• Lead Sponsor: Oxford University Clinical Research Unit, 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-15
• Primary Completion: 2013-12
• Study Completion: 2014-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients who are stable at Day 3, 7 and 14	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

Secondary Outcome Measures

Name	Time	Method
Need for mechanical ventilation	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ventilation time	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Day 14 mortality	14 days	Proportion of patients who die at Day 14
Length of stay (days)	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	Length of stay from admission to discharge in days

Trial Locations

Locations (2)

National Hospital of Tropical Diseases; 🇻🇳 Hanoi, Vietnam

Nguyen Tri Phuong Hospital; 🇻🇳 Ho Chi Minh, Vietnam