All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB)

All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB)

Title: All-oral shorter treatment regimens for multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB): Evaluating their effectiveness, safety, feasibility, cost-effectiveness and impact on the quality of life of patients in Pakistan

Location: Twelve PMDT sites i.e. ten in Punjab, and one each in Islamabad and Muzafarabad (AJK) districts.

Duration: January 2020 to December 2023

Funded by: World Health Organization

Study Objectives:

To determine the effectiveness, safety, feasibility, cost-effectiveness and impact on the quality of life of all-oral shorter MDR/RR-TB regimen of 9/12-month duration under programmatic conditions.

Study Design:

A stepped-wedge design comparing patients receiving the New all-oral shorter MDR/RR-TB regimen (i.e. Bedaquiline + Linezolid) and patients receiving the standard all-oral MDR/RR-TB short treatment regimen (i.e. Bedaquiline) at 12 PMDT sites in Pakistan. About 300 intervention and 300 comparator patients will be recruited in the trial.

Evaluation criteria:

  1. Effectiveness:

Primary outcome: the proportion of MDR/RR-TB patients who have a favorable treatment outcome. This is defined as “cured” or “treatment completed” without recurrence during 12 months after the end of the treatment.

  1. Safety:

Primary outcome: the proportion of MDR/RR-TB patients who have a serious adverse event up to 12 months after the end of the treatment.

Secondary outcomes: proportion of MDR-TB patients treated with an all-oral shorter MDR/RR-TB treatment who:

    • died while on treatment
    •  had treatment failure
    • had a recurrent episode of MDR-TB during the 12-month follow-up period
    • relapsed during the 12-month follow-up period
    • were lost to follow-up during treatment
    • are “cured without permanent disability” (up to one year after the end of the treatment)
    • complete at least 90% of doses (treatment adherence)
    • experience adverse events of special interest
  1. Health related Quality of Life
  2. Feasibility
  3. Cost-effectiveness from a health care perspective; affordability and socioeconomic impact for patients