Phase IIb/c trial of a novel anti-tuberculosis oral regimen completed within one year

The Challenge

Completing this trial end-to-end within one year was an imperative for the client, who was investigating a novel oral treatment in drug-susceptible pulmonary tuberculosis. Micron’s collaborative relationships with high-calibre imaging centres was pivotal to recruitment and retention of patients.

Micron's Contribution

Our Approach & Impact

A Phase IIb/c trial of a novel oral treatment regimen for drug-susceptible pulmonary tuberculosis was planned by the client, and the trial assessments included stringent imaging criteria. Recruitment of patients with tuberculosis can be challenging, and retaining participation of the full quota of 122 patients to assess response to treatment was crucial to the trial’s success.

Prudent selection of eight Investigator sites was complemented by establishing partnerships with accomplished radiologists at leading imaging centres. Conducting the trial presented an array of challenges, including provision of a complex dosing regimen, and multiple visits with a detailed schedule of PET/CT scans. Micron provided medical monitoring, safety management, and had oversight on laboratory testing. Micron also ensured that all ethics approvals and regulatory procedures were timely and compliant.