Community-Acquired Infections Clinical Trial
Official title:
A Randomized Controlled Trial of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Community Acquired Pneumonia
This study evaluates the integrated traditional Chinese and Western medicine in the treatment of severe community acquired pneumonia in adults. Half of participants will receive traditional Chinese and Western medicine in combination, while the other half will receive a placebo traditional Chinese and Western medicine.
Improving the care of patients with community-acquired pneumonia (CAP) has been the focus of
many different organizations. Such efforts at improvement in care are warranted, because
CAP, especially severe CAP remains the leading cause of death in the world. Despite advances
in antimicrobial therapy, rates of mortality due to severe CAP have not decreased
significantly since penicillin became routinely available.
traditional Chinese Medicine, has been used for thousands of years in treating pneumonia. To
date, it has become popular and widely practiced in many countries around the world. In the
past decades, Evidences from both clinicians and patients suggest that there is some
beneficial effect of TCM on severe CAP.
At present, there are many therapies available for patients with severe CAP, it is difficult
for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy
of combination conventional drug and TCM to the conventional drug and placebo, and then
determine which one is the better therapy, providing a scientific basis for clinical
decision.
This is a multi-center, randomized, controlled trial to compare the efficacy of two
therapies for patients with severe CAP. 198 subjects will be randomly assigned to one
therapies (conventional drug, and the combination of conventional drug and TCM) for 28 days
treatment. After the treatment period, subjects in two arms will be followed up for 12
weeks. The primary outcomes will include treatment failure, and secondary outcomes Time to
clinical stability, length hospital stays, in-hospital mortality, SOFA questionnaire,
quality of life (CAP-PRO ) and health economics.
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