A clinical trial to assess a nine-month standardised treatment regimen for multidrug-resistant tuberculosis (MDR-TB) has begun in South Africa, Ethiopia and Vietnam. The trial is being conducted by TREAT-TB, an initiative managed by the International Union Against Tuberculosis and Lung…
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Written by Naftali Mwaura
Written by Henry Neondo
A clinical trial to assess a nine-month standardised treatment regimen for multidrug-resistant tuberculosis (MDR-TB) has begun in South Africa, Ethiopia and Vietnam. The trial is being conducted by TREAT-TB, an initiative managed by the International Union Against Tuberculosis and Lung Disease (The Union), and will eventually involve 400 patients in Africa and Asia
The regimen to be tested is modeled on one used in a non-randomised observational study in Bangladesh, which demonstrated excellent outcomes, including an 87% cure rate.
The UK Medical Research Council Clinical Trials Unit (MRC CTU) is the main partner working with The Union to implement STREAM, with the Institute of Tropical Medicine (ITM), Antwerp, Belgium providing laboratory support.
“Our trial is designed to determine whether comparable results can be achieved in different settings”, says Dr I.D. Rusen, Project Director for TREAT TB. “The aim is to show that this shorter treatment regimen is at least as effective as the current lengthier treatments used throughout the world to treat MDR-TB”.
Identifying improved regimens for MDR-TB is a public health priority, because of the steady increase in the number of cases, now estimated at 600,000 worldwide.
MDR-TB is typically much harder to diagnose and treat than drug-susceptible TB and more frequently fatal; in addition, failure to treat the disease effectively has led to further mutations of Mycobacterium tuberculosis into extensively drug-resistant strains (XDR-TB), which are nearly incurable.
According to Dr Rusen, the outcomes of this clinical trial are expected to provide important evidence to inform MDR-TB treatment recommendations from global technical agencies, including the World Health Organization (WHO) and The Union, and national policy and guidelines for MDR-TB treatment in high-burden countries.
The TREAT TB clinical trial, which has been dubbed STREAM (Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB), began enrolling patients at King George V Hospital in Durban, South Africa in July 2012.
Since then additional sites have been initiated for the trial, including Sizwe Tropical Diseases Hospital in Johannesburg, South Africa; St. Peter’s Hospital; the Armauer Hansen Research Institute in Addis Ababa, Ethiopia; and Pham Ngoc Thach Hospital in Ho Chi Minh City, Viet Nam. As of 21 May 2013, 86 patients had already been enrolled into the trial.
The participating countries were selected based on their disease burden, as well as other criteria, such as their ability to provide close supervision of patients, the quality of their laboratory facilities and the support of their national tuberculosis programmes.
Patients treated with the STREAM regimen will receive moxifloxacin, clofazimine, ethambutol and pyrazinamide for nine months, supplemented by prothionamide, kanamycin and isoniazid during an intensive phase of four months.
Once the full complement of patients has been enrolled, the trial is expected to run for two years, with results available in 2016.
Funding for TREAT TB (Technology, Research, Education and Technical Assistance for TB) is provided by the US Agency for International Development (USAID).
Written by Kevin Wafula
While African parliamentarians have low levels of knowledge on climate change and its financing mechanism, the high number of involvement in the process with the support of external donors does not augur well for the continent, Dorothy Tembo, Centre for Environmental Policy, Malawi said at the ongoing workshop on Climate Finance Effectiveness in Africa, Magalisberg, South Africa.
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The Canadian government will provide seed money to accelerate the implementation of innovative and home-grown projects that aim to reduce disease burden in Sub-Saharan Africa.