Causes and Outcomes of Community Acquired Pneumonia (CAP)

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

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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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

More Information

Additional Information:

OUCRU studies public site 

• Responsible Party: Oxford University Clinical Research Unit, Vietnam
• ClinicalTrials.gov Identifier: NCT01336036
• Other Study ID Numbers: 03HN
• First Posted: April 15, 2011
• Last Update Posted: September 30, 2016
• Last Verified: September 2016

Additional relevant MeSH terms:

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases