Causes and Outcomes of Community Acquired Pneumonia (CAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oxford University Clinical Research Unit, Vietnam
Sponsor:
Information provided by (Responsible Party):
Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier:
NCT01336036
First received: April 6, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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
Community Acquired Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital

Resource links provided by NLM:


Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:
  • Proportion of patients who are stable at Day 3, 7 and 14 [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]

    • 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:
  • Day 14 mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Proportion of patients who die at Day 14

  • Length of stay (days) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    Length of stay from admission to discharge in days

  • Need for mechanical ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Length of ventilation time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sputum Blood Urine Nasal and Throat swab


Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336036

Contacts
Contact: Kinh V Nguyen, PhD +844 35764305 kinhvaac@yahoo.com

Locations
Vietnam
National Hospital of Tropical Diseases Recruiting
Hanoi, Vietnam
Contact: Ngan D Ta, MD    +844 35764305    ngantadieu@yahoo.com   
Principal Investigator: Kinh V Nguyen, PhD         
Sub-Investigator: Peter Horby, MD         
Sub-Investigator: Heiman Wertheim, PhD         
Sub-Investigator: Ha H Nguyen, MD         
Sub-Investigator: Trung V Nguyen, PhD         
Sub-Investigator: Trinh T Dao         
Nguyen Tri Phuong Hospital Not yet recruiting
Ho Chi Minh, Vietnam
Contact: Rogier van Doorn, MD         
Sub-Investigator: Van H Pham, MD         
Sub-Investigator: Dung T Le, MD         
Sub-Investigator: Rogier van Doorn, MD         
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
  More Information

Additional Information:
No publications provided

Responsible Party: Oxford University Clinical Research Unit, Vietnam
ClinicalTrials.gov Identifier: NCT01336036     History of Changes
Other Study ID Numbers: 03HN
Study First Received: April 6, 2011
Last Updated: November 22, 2013
Health Authority: Vietnam: Ministry of Health

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

ClinicalTrials.gov processed this record on October 29, 2014