Levofloxacin versus placebo for the treatment of latent tuberculosis among contacts of patients with multidrug-resistant tuberculosis (the VQUIN MDR trial): a protocol for a randomised controlled trial

Levofloxacin versus placebo for the treatment of latent tuberculosis among contacts of patients with multidrug-resistant tuberculosis (the VQUIN MDR trial): a protocol for a randomised controlled trial.

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Item Type: Article
Status: Published
Official URL: https://doi.org/10.1136/bmjopen-2019-033945
Journal or Publication Title: BMJ Open
Volume: 10
Number: 1
Page Range: e033945
Date: 2020
Divisions: Tuberculosis
Depositing User: General Admin
Identification Number: 10.1136/bmjopen-2019-033945
ISSN: 2044-6055
Date Deposited: 04 Jan 2021 02:29
Abstract:

Introduction Treatment of latent tuberculosis infection (LTBI) plays a substantial role in the prevention of drug-susceptible tuberculosis (TB). However, clinical trials to evaluate the efficacy of preventive therapy for presumed multidrug-resistant (MDR) LTBI are lacking. This trial aims to evaluate the efficacy of the antibiotic levofloxacin in preventing the development of active TB among latently infected contacts of index patients with MDR-TB.

Methods and analysis A double-blind placebo-controlled parallel group randomised controlled trial will be conducted in 10 provinces of Vietnam. Household contacts living with patients with bacteriologically confirmed rifampicin-resistant or MDR-TB will be eligible for recruitment if they have a positive tuberculin skin test or are known to be immunosuppressed, and do not have active TB. Participants will be randomised to receive either levofloxacin or placebo tablets once per day for 6 months. Screening for incident TB will be performed at 6 months intervals. The primary study outcome is the incidence of bacteriologically confirmed TB within 30 months after randomisation. Analysis will be by intention to treat, using Poisson regression.

Ethics Ethical approval from the University of Sydney Human Research Ethics Committee was obtained on 29 April 2015 (2014/929), and from the Vietnam Ministry of Health Institutional Review Board on 30 September 2015 (4040/QD-BYT).

Dissemination Findings of the study will be published in peer-reviewed publications and conference presentations.

Trial registration number ACTRN12616000215426.

Creators:
Creators
Email
Fox, Greg J
UNSPECIFIED
Nguyen, Cam Binh
UNSPECIFIED
Nguyen, Thu Anh
UNSPECIFIED
Tran, Phuong Thuy
UNSPECIFIED
Marais, Ben J
UNSPECIFIED
Graham, Steve M
UNSPECIFIED
Nguyen, Binh Hoa
UNSPECIFIED
Velen, Kavi
UNSPECIFIED
Dowdy, David W
UNSPECIFIED
Mason, Paul
UNSPECIFIED
Britton, Warwick J
UNSPECIFIED
Behr, Marcel A
UNSPECIFIED
Benedetti, Andrea
UNSPECIFIED
Menzies, Dick
UNSPECIFIED
Nguyen, Viet Nhung
UNSPECIFIED
Marks, Guy B
UNSPECIFIED
Last Modified: 04 Jan 2021 02:29
URI: https://eprints.centenary.org.au/id/eprint/780

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