STREAM starts screening patients in Europe

On July 11, the first patient in Europe was screened for Stage 2 of the STREAM trial in Moldova. 

Although the country’s population is  only ~3 million, over 500 new MDR-TB cases were registered in 2016. Given the high burden of disease in the country,  Moldova was identified as a logical location for implementing the STREAM trial. The national TB referral and research hospital – Institute of Phthisiopneumology “Chiril Draganiuc” – in Chisinau quickly expressed strong interest in leading the trial in Moldova and has meticulously completed all preparations required to initiate screening.

Dr. Elena Tudor, principal investigator for STREAM in Moldova, has high hopes for improving treatment outcomes for her patients: “I would be pleased if my country could improve its current treatment success rate for MDR-TB patients which is [currently] at 57.1% and get closer to the success rate reported from Bangladesh with a 79% success rate.”

Dr. Elena Tudor in front of the Institute of Phthisiopneumology “Chiril Draganiuc” in Chisinau, Moldova.

Dr. Elena Tudor in front of the Institute of Phthisiopneumology “Chiril Draganiuc” in Chisinau, Moldova.

STREAM Stage 2 is the result of a unique collaboration between USAID, Janssen Pharmaceuticals and The Union/Vital Strategies.  The STREAM team is proud to welcome the experienced study team from Moldova to the STREAM trial.

STREAM Staff at South Africa STREAM Stage 2 Sites

Soo Chung, a subcontracts manager at Vital Strategies, was recently in South Africa for a monitoring visit.  Soo oversees the contracts and budgeting for all STREAM sites and she visits sites regularly to monitor spending and compliance with USAID regulations. During her recent South Africa visit, Soo had the opportunity to speak with members of the study team at the Johannesburg site (Helen Joseph Hospital) and the Pietermaritzburg site (Doris Goodwin Hospital).

Soo spoke with Michael, who is the Health and Safety Officer and drives patients with MDR-TB to the STREAM site at in Johannesburg for their appointments.  Michael meets with government officials on a quarterly basis to ensure that proper infection control procedures are followed at the Clinical Health Research Unit at the Wits Health Consortium, which oversees the trial in Johannesburg and DurbanHe also ensures that the STREAM vehicle is clean and sanitized, often starting his day an hour before his scheduled start time to make sure the job is done well.

Michael shared that, "[STREAM] is important because recently South Africa has been realizing...what research is. There are people who don't receive the treatment they need since it's too expensive for people in economically disadvantaged groups. The trial helps the sick people receive professional treatment that they wouldn't be able to afford on their own."

Soo also discussed trial progress with Samantha Aucock, the STREAM trial coordinator at Pietermaritzburg, and members of the finance/operations teams at Wits.  Samantha ensures the site provides care according to the STREAM protocol and organizational standards, and actively oversees coordination and collaboration with the trial sponsor and stakeholders.  Ina de Jongh and Simone Thomson (pictured here) are the General Manager of Operations and Divisional Grants Manager, respectively, at Wits Health Consortium. Ina works on contracts setup, budget approvals, and report approvals and Simone creates financial reports and oversees compliance with USAID regulations.

Samantha explained that "While South Africa has the highest TB burden per population size in the world, the HIV/TB burden is one of the leading causes of death in the country.  This has devastating effects on the individuals, communities, and society at large. Shorter, less toxic and easy-to-take treatment could ensure improved outcomes and higher treatment adherence, benefiting patients and easing the burden on the health sector."

STREAM enrolls 100th patient in clinical trial testing shortened MDR-TB regimens

Kwanele[1] is the 100th patient to enroll in Stage 2 of the STREAM clinical trial - the first large-scale, multi-country clinical trial to evaluate shorter treatment regimens for multidrug-resistant tuberculosis (MDR-TB).

He enrolled in the trial after recognizing the night sweats and persistent cough he was having to be symptoms of TB, which he had been previously treated for in 2011. He is receiving treatment at the King Dinuzulu Hospital in Durban, South Africa. Durban is located in KwaZulu Natal, the South African province with the highest incidence of TB and HIV prevalence in the country, with over one-fourth the total burden.

STREAM Stage 2 is testing shortened regimens for MDR-TB, including a nine-month, all-oral treatment that eliminates the painful injections that can cause severe side effects. STREAM Stage 2 is the result of a unique collaboration between The Union, Vital Strategies, the United States Agency for International Development (USAID) and Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Kwanele said: “I am very happy with the care I am getting.

“I’ve benefitted from the informed consent process and I like the fact that I always see the same staff members.”

Kwanele’s family members have all screened negative for TB but he said he would encourage them to join the trial if it had been necessary.

Dr. Nosipho Ngubane, one of the doctors overseeing the trial at King Dinuzulu Hospital, said: “A shorter, more tolerable regimen for MDR-TB makes sense. If we want to eradicate MDR-TB we must decrease side effects of the treatment so patients can adhere. Most important is to find a way to safely give patients fewer – if any – injections, as the associated hearing loss and kidney failure often make treatment adherence impossible.

STREAM study team at King Dinuzulu Hospital in Durban, South Africa.

STREAM study team at King Dinuzulu Hospital in Durban, South Africa.

"Durban has one of the highest burdens of TB – and MDR-TB in particular – in the world. If the trial works in Durban, it will work everywhere.”

The shortened treatment regimens in Stage 2 incorporate the novel anti-TB medicine bedaquiline. STREAM Stage 2 is expected to be one of the largest MDR-TB trials ever conducted, with trial sites currently operating in South Africa, Ethiopia, and Mongolia, and additional sites in Asia, Eastern Europe and Africa expected. The outcome of the trial will provide important evidence to guide global treatment guidelines for MDR-TB.

“It’s worth being part of any clinical trial”, says Nonkqubela Bantubani, Study Coordinator at King Dinuzulu Hospital. “We always say to the patients that you will be part of something that will make a difference not just for you, but also for the world.”

The Union, Vital Strategies and key global partners including the Medical Research Counsel Clinical Trials Unit at University College London, Institute of Tropical Medicine, Antwerp and Liverpool School of Tropical Medicine are implementing the STREAM clinical trial in collaboration with trial sites around the world.

[1] Name has been changed

The National Center for Tuberculosis and Lung Diseases in Tbilisi Joins STREAM Trial

On May 15 to 17, 2017, a site initiation visit was held at the National Center for Tuberculosis and Lung Diseases (NCTLD) in Tbilisi, Georgia, marking the final step prior to commencing patient recruitment for the STREAM Clinical Trial Stage 2. Stage 2 of the STREAM clinical trial was initiated by The International Union Against Tuberculosis and Lung Disease (The Union) and is being implemented as part of the USAID-funded TREAT TB initiative.  The trial represents a unique collaboration between USAID, Janssen Pharmaceuticals, The Union and The Union’s affiliate, Vital Strategies, and aims to generate evidence regarding the effectiveness of shorter treatment regimens for multi-drug resistant tuberculosis (MDR-TB). The NCTLD was established in 2001, has 66 beds in its MDR-TB ward and acts as a referral hospital for patients with tuberculosis elsewhere in Georgia.

Vital Strategies, Medical Research Council Clinical Trials Unit at University College London, and Quintiles staff trained 35 Georgian nurses, microbiologists, data managers, field workers, and a pharmacist who will be involved with the STREAM trial. The director of the NCTLD, Dr. Zaza Avaliani, highlighted, “This trial is important for [Georgia] because it contributes to the national priority to eliminate TB and it fosters Georgia’s position as a regional leader in TB treatment.”

Generating Evidence Through Operational Research

On May 9, 2017 in Tagaytay, Philippines, public health professionals from the National Tuberculosis Program, Lung Center of the Philippines, National TB Reference Laboratory, and regional offices and hospitals participated in the first of a seven-day TREAT TB Operational Research training course in the country. The training course was led by MDR-TB expert and The Union Consultant, Dr. Chen-Yuan Chiang. The course supports the Philippines Department of Health’s strategy to intensify research and innovation among public health practitioners and researchers in its bid to end TB in the country.

This course aims to facilitate theoretical and practical skills of participants in undertaking the entire operational research process from conceptualization of a research question, to data analysis, and publication. The participants learn and share knowledge within a team of motivated participants and talented facilitators in operational research, who also serve as mentors, from different countries. 

Building capacity of public health professionals will help the National TB Program achieve its goals, particularly national scale-up of the Standard Short Treatment Regimen (SSTR) for MDR-TB. Operational research on the shorter treatment regimen and other priority areas has the potential to provide key insights on programmatic and clinical management of patients with MDR-TB, improve TB-control, and strengthen the country’s capacity to successfully conduct operational research to improve programs.

The six teams in this course will each develop a research protocol, implement their study, and draft a manuscript for publication. Course participants will continue to receive mentorship from facilitators through an online module and a second in-person session in 2018.