Causes and Outcomes of Community Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

— CAP  

Official title:

Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336036
• Other study ID #: 03HN
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: September 29, 2016
• Start date: February 2011
• Est. completion date: February 2014

Study information

• Verified date: September 2016
• Source: Oxford University Clinical Research Unit, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Observational

Clinical 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 severity of CAP

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
Vietnam	National Hospital of Tropical Diseases	Hanoi
Vietnam	Nguyen Tri Phuong Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Clinical Research Unit, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 14 days	No
Secondary	Day 14 mortality	Proportion of patients who die at Day 14	14 days	No
Secondary	Length of stay (days)	Length of stay from admission to discharge in days	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Need for mechanical ventilation		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Length of ventilation time		participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No

External Links

•   OUCRU studies public site