Background
Tuberculosis remains one of the most stubborn infectious diseases of our time. Even today, standard drug-susceptible TB therapy can take six months or longer — a duration that often leads to treatment fatigue and poor adherence. Recognising this unmet need, our client set out to evaluate a novel oral regimen designed to shorten treatment time while maintaining safety, efficacy, and patient tolerability.
To make that possible, the sponsor initiated a Phase IIb/c trial in adult patients with pulmonary tuberculosis. The study aimed to collect detailed pharmacokinetic (PK), imaging, and biomarker data — including PET/CT scans and novel efficacy markers — to provide a clear understanding of how the new therapy performed compared to conventional care.
The Challenge
Tuberculosis trials are logistically and scientifically demanding. They involve multiple visits, long dosing schedules, and strict imaging timelines — all of which place significant demands on participants and sites. Ensuring compliance across sites, keeping patients engaged through months of visits, and coordinating central imaging reviews under these conditions required a level of oversight that went beyond routine clinical management.
Micron’s Contribution
Micron worked hand-in-hand with the sponsor to design and deliver an operational model that kept every moving part aligned. Eight investigator sites were carefully selected for their experience in TB research and patient management.
From the start, Micron took ownership of key trial operations — regulatory submissions, clinical supplies, medical monitoring, and safety oversight — ensuring that every element progressed without delay. A strong emphasis was placed on collaboration: sites received consistent support, rapid feedback on queries, and flexibility in visit scheduling to accommodate participants’ personal and medical needs.
The imaging component was a particular focus. Micron established partnerships with experienced PET/CT centres, coordinating directly with radiologists to maintain timing accuracy and adherence to the stringent imaging standards defined in the protocol. By maintaining these relationships closely, we ensured that each data point — from scan to analysis — met the trial’s precision requirements.
The Result
The study achieved what many in the field would consider an operational milestone:
122 participants enrolled within one year.
Zero loss to follow-up — a rare accomplishment in long, high-intensity TB studies.
Site activation achieved within four months of regulatory approval, and first dosing began one month later.
These results reflected not only solid project management but the strength of the relationships built at site level — between investigators, radiologists, and the Micron team.
Outcome and Impact
By combining scientific rigour with operational flexibility, Micron helped deliver a complex study on time and without compromise. The project demonstrated that even in one of the toughest therapeutic areas, thoughtful coordination and adaptability can keep trials on schedule and data quality uncompromised.
The findings supported the continued development of a potentially transformative TB regimen — one that could shorten treatment duration and improve patient outcomes worldwide.
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