There have been some important changes to the delamanid compassionate use protocol. Delamanid is available for compassionate use and can be obtained from the company at no charge on a patient-by-patient basis.
The company has made some changes to their access and eligibility criteria and these are summarized below. Perhaps most exciting is that the pediatric formulation of delamanid (a 25mg dispersible tablet) will also be available via compassionate use. This formulation is not yet on the market but is an important tool for younger children with RR-TB. We are thrilled the company has now made this formulation available for the children who need it.
Please find additional information below.
Updates to Delamanid Compassionate Use Protocol
- Male and female patients ≥ 3 years of age are eligible for CU DLM enrolment
- Prior delamanid use is no longer an exclusion criterion
DLM treatment duration
- The current protocol 242-302-00014 allows treatment extension of CU DLM on a case by case basis. Re-application for a treatment extension with delamanid can be made in exceptional cases, in order to minimize the probability of a resistance development to anti-TB treatment and/or enhance the likelihood of a favourable treatment outcome in difficult to treat cases.
- IMP of the pediatric formulation (dispersible tablets of 25 mg) is undergoing final packaging and testing and shall become available for patients enrolled in the updated CU protocol 242-302-00014 shortly.
PV reporting timelines
- The updated CU protocol 242-302-00014 requires reporting of all safety information within 24 hours (not just for SAE as in the previous CU protocol 242-12-401 but all AEs + safety information)
The Paediatric Drug-Resistant TB Donation Initiative is led and funded by the Stop TB Partnership’s Global Drug Facility in partnership and with financial support from USAID.
The Sentinel Project resource, “How to Care for People Exposed to Drug-Resistant Tuberculosis: A Practical Guide” is now available.
This Guide builds on World Health Organization (WHO) recommendations for the management of individuals who have been exposed to TB and DR-TB, but focuses more on the practical implementation of interventions that should take place in the post-exposure setting. While the WHO policies stress that investigating household contacts of TB patients must be done on an “urgent” basis for all contacts of a patient with DR-TB, there is limited information available on what these evaluations and interventions should include. Furthermore, many of the recommendations and tools that do exist only focus on medical issues, omitting other pressing psychosocial needs that must be routinely assessed as well. DR-TB affects not only individuals but their households as well. Even when only one person has become sick, the whole household requires some intervention to reduce discrimination, improve patient support, and avoid unnecessary morbidity and mortality. This Guide aims to provide a way of thinking about the challenges around those exposed to DR-TB. It also aims to provide guidance on DR-TB prevention and management strategies needed to address the enormous health threat presented by DR-TB, as well as the tools necessary to carry them out.
For additional translations of the Field Guide, please send a note to Sentinel_Project@hms.harvard.edu.
In the December 2015 edition of Public Health Action, a Sentinel Project task force published the results of their work. In this original report, they aimed to systematically identify and rank research priorities in childhood drug-resistant TB through a survey of the Sentinel Project network. Research priorities identified in the study include the best combination of existing diagnostic tools for early diagnosis, reasons for and interventions to improve treatment outcomes, adverse effects of drugs and optimal treatment duration, prevalence of drug-resistant TB, and interventions for optimal diagnosis, treatment and modalities for treatment delivery.
We thank all of the colleagues who participated in the survey.
On April 12-13, 2015, members of the Sentinel Project participated in the “Global Consultation on Best Practices in the Delivery of Preventive Therapy for Households Exposed to Drug-Resistant Tuberculosis” held in Dubai, UAE at the Harvard Medical School Center for Global Health Delivery–Dubai. A global panel of 51 tuberculosis practitioners from 33 cities in 19 countries gathered to synthesize evidence and produce practical guidance for the management of children and adults who are household contacts of patients with DR-TB. Download the full meeting proceedings “Global Consultation on Best Practices in the Delivery of Preventive Therapy for Households Exposed to Drug-Resistant Tuberculosis” as a PDF here.
A policy brief outlining principles and recommendations for the management of children and adults who are household contacts of patients with DR-TB was also produced from the meeting. Download the policy brief “Post-Exposure Management of Multidrug-Resistant Tuberculosis Contacts: Evidence-Based Recommendations” as a PDF here.
On Friday, December 4, 2015, the Sentinel Project will be hosting a symposium entitled, “Research is Needed to Increase Children’s Access to Drug-Resistant TB Care,” at the 46th Union World Conference on Lung Health in Cape Town, South Africa. This event will bring together pediatric DR-TB researchers, caregivers and advocates to discuss the current needs and advances in research for children with drug-resistant TB.
Presentation topics will include research priorities for pediatric DR-TB, the need for child-focused program targets, pediatric DR-TB clinical trials, opportunities for and barriers to development of pediatric second-line drug formulations, and advocacy strategies for pediatric DR-TB research.
The Symposium will be held from 13:30 to 15:00 in Room MR 2.44-2.46 on Friday, December 4, 2015 at the Cape Town International Convention Centre. We hope to see you there!
For more information about the 46th Union World Conference on Lung Health, visit the conference website here.