Factors associated with screening failure and study withdrawal in multidrug-resistant TB

Area of Science:

• Clinical Medicine
• Infectious Diseases
• Tuberculosis Research

Background:

• Multidrug-resistant tuberculosis (MDR-TB) presents significant treatment challenges.
• Clinical trials are essential for developing new MDR-TB therapies.
• Understanding factors influencing patient participation is key to trial success.

Purpose of the Study:

• To identify baseline factors associated with screening failure in MDR-TB patients.
• To identify baseline factors associated with study withdrawal among enrolled MDR-TB patients.
• To improve patient selection and retention in MDR-TB clinical trials.

Main Methods:

• Secondary analysis of a Phase II randomized, blinded clinical trial (ClinicalTrials.gov: NCT01918397).
• Screened 255 patients for eligibility in Peru and South Africa.
• Used Poisson and Cox regression models to analyze screening failure and study withdrawal predictors.

Main Results:

• Over half (56.5%) of screened patients failed, primarily due to unsuitable resistance profiles (72.9%).
• No significant baseline predictors for screening failure were identified in multivariable analysis.
• Among enrolled patients, 30% withdrew, mainly due to non-adherence or consent withdrawal, with no baseline predictors found.

Conclusions:

• No baseline factors independently predicted screening failure in this MDR-TB trial.
• No baseline factors independently predicted study withdrawal in this MDR-TB trial.
• Further research may be needed to identify actionable strategies for optimizing patient enrollment and retention in MDR-TB trials.