Shaping a better future for children exposed to MDR-TB
Globally, multi-drug-resistant tuberculosis (MDR-TB) - a form of tuberculosis caused by strains which are resistant to the standard TB medicines - is increasing. In 2019 alone, around 500,000 people became ill with drug-resistant TB.
Children are particularly at risk of contracting the disease with at least one million exposed to MDR-TB each year, while diagnostic and preventive solutions are lacking.
Despite the World Health Organization’s call for high-quality studies to prevent MDR-TB in children, there is still limited available evidence from trials on potential preventive and adapted medications.
While children have very good outcome if treated in a timely manner with MDR-TB therapy, current treatment is long, complex and expensive with potentially serious side effects which makes prevention even more essential.
As part of the efforts to support research in this area, the Unitaid-funded “TB-CHAMP” clinical trial is led by the Desmond Tutu TB Centre at the Stellenbosch University in South Africa.
The trial, which is part of the larger Unitaid-supported project “Benefit Kids”, aims to assess the efficacy and safety of TB preventive treatment in young children under 5 who are household contacts of adults with MDR-TB.
Safe, simple and child-friendly
One of the objectives of the study is to determine whether giving a well-known, single TB medication, levofloxacin, for 6 months, will prevent children who have household exposure to MDR-TB, from developing the disease. Another key question TB-CHAMP seeks to answer is whether levofloxacin will be safe and well-suited for children. To verify this, children enrolled in the trial will be followed for one year after the study is completed. To date, the study has enrolled 610 children out of a total target of 1009.
“The trial should provide clear answers as to whether levofloxacin as a single drug will prevent young children from getting MDR-TB. TB-CHAMP will also provide data regarding the safety of long-term levofloxacin use in children,” explains Dr. Susan Purchase, who leads the TB-CHAMP study team at Stellenbosch University.
“Developing a rigorous evidence-based regimen for safe and effective prevention of drug-resistant TB in children is critical to prevent the disease”, said Prof. Anneke Hesseling, the principal investigator of the trial and the director at the Desmond Tutu TB Centre. “This study is the world’s only trial focusing specifically on MDR-TB prevention in children. We are very proud to be leading this effort in South Africa, with our partners. Children affected by MDR-TB remain one of the most underserved populations affected by TB”.
A team effort
To enrol the children in the trial, a large team of clinicians, nurses, researchers, and recruiters have joined forces.
Hazel Davids-Ruiters has been working on the study for more than two years at the Desmond Tutu TB Centre. Credits : Daphne van Ster
Hazel Davids-Ruiters is a member of the recruiting team at the Desmond Tutu TB Centre and has been working on the study for more than two years. Hazel is one of the first people that participants in the study meet. Together with the other recruiters, she contacts patients with MDR-TB and enquires about children who might be eligible for enrolment in the trial.
She notes that for this study, recruitment is particularly challenging, with teams having to identify many adults with MDR-TB over a large geographic area, to find and enrol children under 5 in households. But Hazel is up to challenge and particularly values working with children on a daily basis. “You get to see and hear the children grow up,” she said.
Dr. Simphiwe Simelane, has been working on the “TB-CHAMP” study for the past eight months. Credit : Hazel Davids-Ruiters
Dr Simphiwe Simelane, a clinician who has been working on the study for the past eight months, drives the initial screening and enrolment of children and evaluates participants during their follow-up visits.
As part of the trial, she assesses each child for any features of the disease and seeks to identify any possible adverse reactions to the medication. She highlights that one of the advantages of the study is that it allows health workers to detect the disease in children at an earlier stage than with routine services.
She places hopes in the trial: “This study could have an important impact on the way we will provide care to children with close exposure to someone with MDR-TB in the future,” highlights Dr. Simphiwe. “If successful, children will be able to receive TB preventive therapy with one medication that is safe, effective and adapted to their needs”.
Shaping the future of MDR-TB prevention
The findings from the TB-CHAMP study could be critical in shaping future responses to MDR-TB prevention and change the lives of thousands of families exposed to the disease.
“Can you imagine being diagnosed with a serious disease, that may be stigmatised in your community, rob you of your health and livelihood? Treatment for your disease involves months of daily clinic visits and swallowing multiple tablets with unpleasant side effects,” said Dr. Susan Purchase. “You also need to cope with the thought that your disease puts the lives of your loved ones at risk. We want to give parents and caregivers a simple, safe and effective way to protect their children”.
Similarly, Daphne Van Ster, a site manager in Cape Town who has been working on the trial since its beginning hopes that in the future, the study will allow “parents to know that there is a safe drug that will work to prevent their children from getting MDR-TB”.
Daphne van Ster is a senior professional nurse who has been working in TB research for the past 12 years. She is a site manager in Cape Town and has been working on the TB-CHAMP trial since it started in 2017. Credit : Simphiwe Simelane
While the enrolment process is still ongoing, much capacity has been built for clinical research and earlier diagnosis of childhood MDR-TB in South Africa. As of December 2020, the interim analysis of data is underway.
The TB-CHAMP study started in 2017 and is conducted in several sites in South Africa: the Desmond Tutu TB Centre, Stellenbosch University, in Cape Town; the Perinatal HIV Research Unit in Klerksdorp, as part of the Wits Health Consortium; and the Wits Reproductive Health and HIV Institute at Shandukani Research Centre in Johannesburg. The study has enrolled 610 to date children out of a target of 1009 children. It is made possible with the financial support and assistance from Unitaid, through the Benefit Kids Project, led by the Desmond Tutu TB Centre at Stellenbosch University.