TB-CHAMP study comes to an end!
TB-CHAMP is an MDR-TB prevention study led by Stellenbosch University and DTTC and is the only study in the world designed specifically to investigate MDR-TB prevention in young children. The study compares the antibiotic levofloxacin with placebo, to see if levofloxacin is safe and effective to prevent TB in children living with adults who have drug-resistant TB. It is being conducted at five sites in different communities across South Africa.
The study opened in 2017, and encountered numerous recruiting, funding and other challenges, including of course the major disaster that was COVID-19. Despite all the challenges, 922 patients were recruited, and all have now completed their follow-up at the various study sites. More than 60 people from DTTC have worked on TB-CHAMP in some capacity, and each person has contributed in their unique way. The TB-CHAMP recruiting team screened roughly 5000 index cases over a period of 5 1/2 years, and the clinical team at DTTC enrolled more than 400 young children. Data capturers have dual captured around 50 000 case report forms and our pharmacists have issued roughly 2500 scripts. Our drivers have traveled about 10 times round the circumference of the earth, transporting patients, files and samples! We hope to share the results of this very important work with the WHO and global community as soon as the data is available, to inform national and global policy guidelines.
Members of the TB-CHAMP research team outside their community research site at Beautiful Gate, Phillipi.