Background

The majority of TB patients get completely cured with a 6-month regimen. However, some patients suffer from treatment failure, causing deterioration and requiring prolonged and more toxic treatment.

With drug-susceptible Mycobacterium tuberculosis (Mtb), the difference in treatment outcome may be due to host-related factors. There are known non-genetic factors, including HIV infection, diabetes mellitus, smoking, age, and socio-economic status. Inflammatory phenotypes, which are regulated by host genotypes, might also affect TB susceptibility and treatment outcomes. These risk factors need to be validated and analyzed further in the patients in Vietnam.

Aims

The primary objective of the study is to investigate the causes of the substantial heterogeneity in treatment responses and outcomes from drug-susceptible pulmonary tuberculosis. To meet this objective, we will characterize the clinical, microbiological, and inflammatory responses to anti-tuberculosis therapy in a cohort of 600 adults receiving treatment of regimen I or II for drug-susceptible pulmonary tuberculosis.

The results of this study will also be used to compare with those of a parallel study in multidrug-resistant TB to identify the factors for developing multidrug-resistant TB and predict factors for treatment outcomes.

Study design

We will conduct a prospective observational study of 600 rifampicin-susceptible pulmonary TB patients. These non-multidrug-resistant patients will be followed-up for 12 months from study entry.