CAP: Causes and Outcomes of Community Acquired Pneumonia

Sponsor
Oxford University Clinical Research Unit, Vietnam (Other)
Overall Status
Completed
CT.gov ID
NCT01336036
Collaborator
(none)
300
2
36
150
4.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital
    Study Start Date :
    Feb 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Feb 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Day 14 mortality [14 days]

      Proportion of patients who die at Day 14

    2. 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

    3. Need for mechanical ventilation [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    4. Length of ventilation time [participants will be followed for the duration of hospital stay, an expected average of 2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 National Hospital of Tropical Diseases Hanoi Vietnam
    2 Nguyen Tri Phuong Hospital Ho Chi Minh Vietnam

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Oxford University Clinical Research Unit, Vietnam
    ClinicalTrials.gov Identifier:
    NCT01336036
    Other Study ID Numbers:
    • 03HN
    First Posted:
    Apr 15, 2011
    Last Update Posted:
    Sep 30, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 30, 2016