Published On: 19 March 2024

By Dr Munira Khan

THINK South Africa’s clinical trial unit in Hillcrest is excited to share updates on progress made for the TB ALLIANCE NC009 trial, as well as more info about the ChilPref Ext study

The TB ALLIANCE NC009 trial is currently being conducted in five countries and aims to determine the safety of an investigational product in patients with bacteriologically confirmed drug-sensitive TB. One of the potential benefits of the trial is a shortened treatment period from 24 weeks to 15 weeks.

The Hillcrest Clinical Trial Unit (HCTU) was approved to start screening for the study on December 21, 2023, and visits to healthcare facilities within eThekwini followed. At these visit, a brief overview and potential benefits of the study was shared with healthcare facility staff. To date, the team has visited 17 facilities and strengthened relationships with facility level staff.

As with all clinical trials, participants need to meet specific criteria before they can be screened for a trial. The clinical team has reviewed 31 potential participants; three cases were suitable for screening to date. Our first screening at site was conducted on February 12 this year.

The HCTU also hosted Project Manager, Leandra Lombard, and Study Physician, Morounfolu Olugbosi, at Head Office on February 27 (see photo above). It was an interactive, engaging meeting involving the HCTU study team and the NC009 community engagement team. Team members’ experiences were shared during the meeting, followed by a quick walk through the trial unit.

Children’s preferences for improving TB medicines through extemporaneous formulations

The ChilPref Ext study is a co-development and user-experience evaluation among children, caregivers and their healthcare providers.

Management of drug-resistant TB is children is historically very difficult. Part of the challenge is to administer treatment, as in many situations adult tablets are crushed and used for children.

This study aims to collect information on how best to prepare existing available drug formulations, using a liquid dispenser that helps create suspensions of drugs. TB healthcare providers and caregivers of children treated for drug-resistant TB will interact with the dispenser and provide feedback on its design and utility.

The research assistants in this trial have been preparing for interviews, and on the morning of March 7 two caregivers were interviewed. The team is looking forward to interviewing healthcare providers as the next step.