Causes and Outcomes of Community Acquired Pneumonia

NCT01336036 | Completed

• 1 other identifier: 03HN
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Day 14 mortality

  14 days

• Length of stay (days)

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead

Study Sites (2)

National Hospital of Tropical Diseases

Hanoi, Hanoi, Vietnam

Location

Nguyen Tri Phuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Links

• OUCRU studies public site

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum Blood Urine Nasal and Throat swab

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 15, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

VN (2)