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Causes and Outcomes of Community Acquired Pneumonia (CAP)

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ClinicalTrials.gov Identifier: NCT01336036
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Community Acquired Pneumonia

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 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 : February 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources




Primary Outcome Measures :
  1. Proportion of patients who are stable at Day 3, 7 and 14 [ Time Frame: 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 [ Time Frame: 14 days ]
    Proportion of patients who die at Day 14

  2. Length of stay (days) [ Time Frame: 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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  4. Length of ventilation time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Biospecimen Retention:   Samples Without DNA
Sputum Blood Urine Nasal and Throat swab


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336036


Locations
Vietnam
National Hospital of Tropical Diseases
Hanoi, Vietnam
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

Additional Information:
Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01336036     History of Changes
Other Study ID Numbers: 03HN
First Posted: April 15, 2011    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections