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Clinical Trials/NCT01336036
NCT01336036
Completed
N/A

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

Oxford University Clinical Research Unit, Vietnam2 sites in 1 country300 target enrollmentFebruary 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Community Acquired Pneumonia
Sponsor
Oxford University Clinical Research Unit, Vietnam
Enrollment
300
Locations
2
Primary Endpoint
Proportion of patients who are stable at Day 3, 7 and 14
Status
Completed
Last Updated
9 years ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
February 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • 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)

Study Sites (2)

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