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OpenTrials
Completed

NCT Number: NCT01336036

Causes and Outcomes of Community Acquired Pneumonia

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Hospital of Tropical Diseases, Hanoi, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oxford University Clinical Research Unit, Vietnam

Other

Registry information

Official study title

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

Acronym: CAP

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Apr 15, 2011
Registry last updated
Sep 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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