VQUIN

Preventing multi-drug resistant tuberculosis in a high prevalence setting: ‘Connecting the DOTS’ in Vietnam

VQUIN

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.

SECONDARY OBJECTIVE:

  1. 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

  2. Determine the rate of acquired fluoroquinolone resistance among contacts taking six months of levofloxacin compared to placebo who develop incident tuberculosis

  3. 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

  4. Compare the effectiveness of levofloxacin compared to placebo among contacts of patients with MDR-TB bacilli that are susceptible to fluoroquinolones

  5. Evaluate the cost-effectiveness of 6 months of levofloxacin therapy, compared to placebo, in contacts of patients with MDR-TB

RESEARCH METHOD:

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.

vquinstudy

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.