Preventing multi-drug resistant tuberculosis in a high prevalence setting: ‘Connecting the DOTS’ in Vietnam
STUDY SITES: Hanoi, Nam Dinh, Thanh Hoa, Khanh Hoa, Da Nang, Quang Nam, Ho Chi Minh City, Tien Giang, An Giang and Can Tho
TIMELINE: 2016 – 2020
PROJECT IMPLEMENTER: National Lung Hospital / National TB Program
FUNDED BY: Woolcock Institute of Medical Research
CORE STAKEHOLDERS: Provincial Lung Hospitals of 10 project provinces
PRIMARY OBJECTIVE: To test the effectiveness of levofloxacin given for 6 months, compared to placebo, in the prevention of active TB among household contacts of patients with MDR-TB who have latent tuberculosis infection.
Evaluate the tolerability, adherence, severe adverse events (Grade 3, 4 and 5) and cost-effectiveness of 6 months of levofloxacin therapy, compared to placebo, in contacts of patients with MDR-TB
Determine the rate of acquired fluoroquinolone resistance among contacts taking six months of levofloxacin compared to placebo who develop incident tuberculosis
Determine the difference in specific biomarkers:
(a) between infected contacts from therapy initiation to six months later among compliant contacts allocated to levofloxacin, compared to placebo
(b) between tuberculosis infection and disease
Compare the effectiveness of levofloxacin compared to placebo among contacts of patients with MDR-TB bacilli that are susceptible to fluoroquinolones
Evaluate the cost-effectiveness of 6 months of levofloxacin therapy, compared to placebo, in contacts of patients with MDR-TB
A placebo double-blind randomised placebo-controlled trial of levofloxacin for the prevention of multi-drug resistant tuberculosis (MDR-TB), among infected contacts of patients with MDR-TB.
Analysis will be by intention to treat. We plan to use a marginal Poisson regression model estimated via a generalised estimating equation (GEE) to test the effect of treatment group allocation on the incidence ratio of TB. A cost-effectiveness analysis will be conducted by the end of the study using Markov model.