Simplifying  treatment for drug-sensitive and -resistant tuberculosis

Therapy for tuberculosis is lengthy and expensive. The long duration of treatment and the high burden of pills to be taken daily makes it difficult for some patients to complete therapy. A multidrug regimen of four antibiotics for 6 months is prescribed for drug-sensitive tuberculosis, while more complicated drug-resistant strains require therapy of 9 to 30 months to be eliminated with only a 50% success rate. The drugs used to treat drug-resistant TB can be both orally admitted or injectable and are known to have serious side effects including deafness and blindness. Besides, the difficulties experienced by patients undergoing treatment for TB often lead to non-adherence to therapy which increases the risk of drug resistance and negative treatment outcomes such as relapse.

Novel compounds with promising treatment shortening activity

Bedaquiline (B) and pretomanid (Pa) are novel drugs that recently have been undergoing evaluation in pre-clinical and early phase clinical studies and have shown activity against M. tuberculosis bacteria. Bedaquiline is an FDA and EMA-approved drug already in use for drug-resistant tuberculosis. It has been shown to be active against dormant organisms with promising sterilising activity. Pretomanid is a new chemical entity in clinical development which possesses significant anti-tuberculosis activity and a unique mechanism of action. Most recently, pretomanid has also been approved for use in the treatment of drug resistant tuberculosis.

Supported by an extensive portfolio of in vitro, animal, pre-clinical and clinical studies the SimpliciTB study is testing a novel combination of these drugs complemented by moxifloxacin (M) and pyrazinamide (Z) for 4 and 6 months in drug-sensitive and resistant TB, respectively.

Phase 3 clinical evaluation of the BPaMZ regimen

SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance.

The first patients have been enrolled at the National Centre for Tuberculosis and Lung Disease in Tbilisi, Georgia. SimpliciTB is expected to enrol 450 people with TB, including up to 150 with MDR-TB* across at least 26 centres in ten countries in Africa, Asia, Europe, and Latin America.

Mel Spigelman, president, and CEO of TB Alliance, said: “As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile.

SimpliciTB General Assembly held on 6th October 2021

Delegates from all of our collaborators in the SimpliciTB TB Clinical trial  travelled from across the world to attend the quarterly General Assembly (GA) meeting in Mbeya, Tanzania.

SimpliciTB General Assembly held on 28th – 29th June 2021

Delegates from all of our collaborators in the SimpliciTB TB Clinical trial  travelled from across the world to attend the quarterly General Assembly (GA) meeting in Mbeya, Tanzania.

SimpliciTB General Assembly held on 10th February 2021

Delegates from all of our collaborators in the SimpliciTB TB Clinical trial  travelled from across the world to attend the quarterly General Assembly (GA) meeting in Mbeya, Tanzania.

STAND (Shortening Treatment by Advancing Novel Drugs) Trial

The Infection and Global Health Division are committed to finding new and better treatment for tuberculosis (TB) through high quality clinical trials.  Our work continues to test regimens including the novel drug pretomanid, developed by the TB Alliance.  We...

SimpliciTB General Assembly held on 7th October 2020

The quarterly SimpliciTB General assembly (GA) met by teleconference on 1st July 2020.  There was representation from 12 out of 19 partners.  It was reported that recruitment for the trial has been completed and been very successful, the last patient on the trial has...

SimpliciTB General Assembly held on 1st July 2020

The quarterly SimpliciTB General assembly (GA) met by teleconference on 1st July 2020.  We were delighted to welcome colleagues from across the consortium prompting a lively discussion. The capacity development call for bids closed on 24th June and  the review board...

SimpliciTB General Assembly held on 20th February 2020

Delegates from all of our collaborators in the SimpliciTB TB Clinical trial  travelled from across the world to attend the quarterly General Assembly (GA) meeting in Mbeya, Tanzania.

SimpliciTB General Assembly held on 24th October 2019

The quarterly SimpliciTB General Assembly (GA) met by teleconference on the 24th October. Once again there was excellent representation of the collaborating groups with 15 attendees from 7 countries. The Executive Group (EG) have met regularly and gave a report on...

SimpliciTB General Assembly held on 25th July 2019

The first formal meeting of SimpliciTB General Assembly (GA) took place on the 25th of July. We had an excellent representation of the collaborating groups with 20 attendees from 9 countries. The Executive Group (EG) has been established with colleagues from South...

PanACEA and TB Alliance get SimpliciTB grant

SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance. The trial started in 2018 and the European and Developing...

Medical Monitoring in the SimpliciTB study

The Medical Monitoring team from the University of St Andrews and South Africa assist site investigators to apply appropriate criteria for patient recruitment. Monitors are also available to discuss individual cases where the interpretation of the protocol is unclear.

Medical monitors

  • support the development of clinical aspects of the trial’s protocol
  • establish safety monitoring forms and lines of reporting
  • ensure participant safety and assist in the safe management of adverse events.
  • support the sites in reporting adverse events
  • support definition of patient final outcome
  • maintain regular contact with sites to resolve issues as they arise

This project is part of the EDCTP2 programme supported by the European Union.

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