Fox Respiratory
Research Group
Publications
Tuberculosis Treatment
FLIRT Trial
​​Resistance to isoniazid, one of the most important first-line antibiotics used to treat TB, leads to increased mortality and more advanced drug resistance. The Fluoroquinolone for Isoniazid Resistant Tuberculosis (FLIRT) Trial is the first clinical trial in 25 years to evaluate the effectiveness of new-generation fluoroquinolones antibiotics in treating isoniazid-resistant TB.
Funding agency: National Health and Medical Research Council
Duration: 2024-2028
Locations: Vietnam (multiple provinces), Australia (RPA Hospital, Liverpool Hospital, Paramatta Chest Clinic), Canada (Montreal and Vancouver)
Trials registration: ACTRN12624000654550
VSMART Trial
Therapy for multidrug-resistant tuberculosis is associated with high rates of side-effects, which can result in early treatment discontinuation and poor outcomes. New technologies promise to improve communication between patients and their doctors, potentially improving outcomes. The VSMART Trial is a randomised controlled trial evaluating the effectiveness of a smartphone application (“Dr Smart”) to improve reporting of adverse events and treatment outcomes for patients with multidrug-resistant TB in Vietnam.
Funding agencies: National Health and Medical Research Council (Australia) and NAFOSTED (Vietnam)
Duration: 2020-2025
Locations: 7 provinces in Vietnam
Trial registration: ACTRN12620000681954
CRUSH Trial
Standard therapy for drug-susceptible TB disease lasts up to six months, with a high incidence of side effects that can reduce treatment completion. Shorter and better-tolerated treatments promise to improve treatment outcomes for patients, particularly in resource-limited settings. CRUSH-TB is a phase 2 trial comparing the microbiological treatment outcomes of two 17-week regimens for drug susceptible TB against the 26-week standard treatment with first-line TB drugs.
Funding agency: United States Centers for Disease Control (CDC)
Duration: 2023-2027
Locations: Vietnam (Can Tho Lung Hospital); United States, Canada, Haiti, Uganda, South Africa.
Trial registration: NCT05766267
Tuberculosis Prevention
VQUIN MDR Trial
Multidrug-resistant tuberculosis is an infectious disease that often has a poor prognosis, and requires toxic and costly antibiotic treatments for patients. Antibiotics to prevent drug-resistant tuberculosis among high-risk populations may reduce the risk of disease and help to control the spread of further drug-resistant infection. The VQUIN MDR Trial is a clinical trial evaluating the effectiveness of an oral antibiotic, levofloxacin, to treat latent tuberculosis infection among household members of patients with multidrug-resistant tuberculosis.
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Funding: National Health and Medical Research Council
Duration: 2015-2023
Setting: Vietnam (10 provinces)
Trials registration: ACTRN12616000215426
ACT5 Trial
One in four people worldwide has evidence of tuberculosis infection. Screening and treating tuberculosis infection in the community may help to rapidly reduce the prevalence of TB and stop M. tuberculosis infection from spreading to others in the community. The ACT5 trial is a cluster randomised controlled trial that is evaluating the effectiveness of community-wide screening and treatment for TB infection in Ca Mau Province, Vietnam. This trial is screening >80,000 people and offer treatment to people with TB infection. The outcome of the study is the prevalence of confirmed TB in the community.
Funding: National Health and Medical Research Council
Duration: 2022-2026
Setting: Ca Mau Province, Vietnam
Trials registration:
ASTEROID Trial
People with tuberculosis infection (TBI) have a substantial risk of becoming sick due to the disease, and spreading the infection to other people. Shorter and better-tolerated treatments for TBI promise to reduce the burden for patients taking treatment for this condition. ASTEROID is a phase 3 clinical trial evaluating the effectiveness of a 6 week regimen of daily oral rifapentine in comparison to standard 3-4 month treatments using other antibiotics such as rifampicin. It will recruit over 3,000 participants across multiple countries.
Funding agency: United States Centers for Disease Control (CDC)
Duration: 2023-2028
Locations: Australia (RPA Hospital, Parramatta Chest Clinic, Liverpool Hospital); Vietnam, US, Canada, South Africa.
Trial registration: NCT03474029
PHOENIX Trial
​Household contacts of patients with multidrug-resistant tuberculosis have a high risk of developing drug-resistant tuberculosis themselves. New options for patients with drug-resistant TB infection are urgently needed. This phase 3 clinical trial is evaluating the effectiveness of six months of oral delamanid against isoniazid (standard of care) for the treatment of latent tuberculosis infection.
Funding: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, United States of America
Duration: 2019-2027
Setting: Multiple countries worldwide, including Vietnam (Ho Chi Minh City)
Trials registration: NCT03568383
3HP/4RIF Trial
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Multiple treatments options are now available for tuberculosis infection. However, two of the most commonly-recommended regimens – 16 weeks of daily rifampicin (4RIF) versus 12 doses of weekly rifapentine and isoniazid (3HP), have not been compared. This clinical trial evaluates the proportion of patients who complete Tuberculosis Preventive Therapy with 4RIF against 3HP. It also asks patients about their preferences, to help inform future treatment policies.
Funding: National Health and Medical Research Council
Duration: 2019-2024
Setting: Sydney (8 hospitals)
Trials registration: ACTRN12618001672246
2R Squared Platform Trial
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Shorter and safer treatments for tuberculosis infection may improve treatment completion and therefore reduce the risk that patients will develop TB disease. The shorter and safer trial (to be named) is an adaptive platform trial that compares treatment completion between novel shorter regimens for TB infection against standard six-month therapy rifampicin therapy.
Funding agency: Canadian Institute of Health Research
Duration: 2025-2028
Locations: Vietnam, Canada, Benin, Indonesia
Trial registration:
Chronic Diseases
VCAPS4 Trial
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Chronic obstructive pulmonary disease and asthma are leading causes of respiratory disease that cause substantial morbidity – particularly in resource-limited settings. The VCAPS4 trial evaluates the effectiveness of a common approach to managing these two conditions in order to reduce exacerbation frequency among people with undifferentiated obstructive lung disease. It also evaluates, in parallel, the effectiveness of a simple smoking cessation intervention, using a quit line, for smokers who attend local health facilities in Vietnam.
Funding: National Health and Medical Research Council
Duration: 2017-2023
Setting: 40 hospitals in Vietnam (Ha Noi, Thanh Hoa, An Giang, Ca Mau)
Trials registration: ACTRN12620000649910
Implementation Research
SAPPHIRE Tuberculosis Studies
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​​The Sydney Asia-Pacific Partnership for Health Innovation and Resilient Ecosystems (SAPPHIRE) is a four-year program of work that aims to address some of the biggest public health challenges facing Vietnam: tuberculosis, chronic diseases and antimicrobial resistance. The tuberculosis program of research has two parts. The first will screen >80,000 adults in the general community each year for three years for tuberculosis disease. The project will evaluate methods to scale up community screening at lower cost, with a goal of rapidly reducing the burden of TB. The second TB project will involve the scale-up of levofloxacin preventive therapy and contact investigation among people living with patients who have drug-resistant TB. Our previous research has demonstrated that this population is at high risk of infection. This project builds upon our VQUIN trial, which demonstrated that levofloxacin was effective and well-tolerated, particularly in younger people.
Funding: Department of Foreign Affairs and Trade
Duration: 2024-2027
Setting: Vietnam
SAPPHIRE Chronic Disease
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SAPPHIRE Chronic disease program will evaluate the scale-up of treatment for chronic obstructive pulmonary disease among people living in Vietnam. This study will take the findings of our VCAPS4 clinical trial, and look to expand the use of inhaled medication for treatment of asthma and COPD in district level health facilities. The SAPPHIRE team will also work with radiologists in Vietnam to improve diagnosis of breast cancer and other health conditions. This approach will apply the findings of the previously successful VietRAD program, led by Professor Patrick Brennan.
Funding: Department of Foreign Affairs and Trade
Duration: 2024-2027
Setting: Vietnam
Antimicrobial Resistance
SAPPHIRE Antimicrobial Resistance Study
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SAPPHIRE AMR study will explore the problem of antibiotic resistance in human health and in the agricultural sector in Vietnam. We will scale up the antimicrobial stewardship intervention in district level healthcare facilities in Vietnam, following our recent VRESIST Study C clinical trial. This program aims to reduce inappropriate and excessive antibiotic use, an important driver of antimicrobial resistance. The second component looks at antimicrobial resistance in the agricultural sector. It will measure the prevalence of drug-resistant organisms in the community, and help to understand what motivates the excessive use of antibiotics among farmers.
Funding: Department of Foreign Affairs and Trade
Duration: 2024-2027
Setting: Vietnam
VRESIST Study C
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Interventions to reduce inappropriate antibiotic use are critical to combat antimicrobial resistance, including in resource-limited settings. The VRESIST Study C was a cluster randomised controlled trial comparing a package of antimicrobial stewardship interventions, including audit and feedback by an antimicrobial stewardship committee and the introduction of prescribing guidelines, against usual care. It was conducted in 16 district level hospitals in Vietnam.
Funding: Department of Foreign Affairs and Trade
Duration: 2019-2023
Setting: Vietnam (two provinces)