Investigator(s)
| Submitter |
Lila Maya Adhikari Royal Centers for Disease Control, Ministry of Health Lila Maya Adhikari 
|
| Principal Investigator |
Lila Maya Adhikari Royal Center for Disease Control Lila Maya Adhikari
|
| Co-Investigator(s) |
Pavitra Bhujel Royal Center for Disease Control Pavitra Bhujel
|
| Co-Investigator(s) |
Karchung Tshering Royal Center for Disease Control Karchung Tshering
|
| Co-Investigator(s) |
Rada Dukpa National TB control program, Ministry of Health Rada Dukpa
|
| Co-Investigator(s) |
Jit Bdr Darnal Royal Center for Disease Control Jit Bdr Darnal
|
| Co-Investigator(s) |
Sangay Zangmo Royal Centre for dDisease Control Sangay Zangmo
|
| Co-Investigator(s) |
Tsheten Tsheten Australian National University Tsheten Tsheten
|
Title(s) and abstract
| Scientific title | Emergence of second line drug resistant TB in Bhutan, report from annual drug resistance surveillance 2010-2023 |
| Public title | Emergence of second line drug resistant TB in Bhutan |
| Background | The emergence of drug resistance to second line anti-TB drugs further aggravates the challenges in controlling & ending TB worldwide. In 2021, of the 71% (2.4/3.4 million) bacteriologically confirmed pulmonary TB tested for rifampicin resistance, a total of 25038 cases of pre-extensively drug resistant TB (pre-XDR)/extensively drug resistant TB (XDR-TB) were detected (WHO, 2021). In countries with surveillance data, 9.5% of MDR TB cases also had resistance to fluoroquinolone and second line injectables or both in 2016 (WHO, 2016) . Globally it is estimated that 6% of MDR-TB are diagnosed as XDR-TB (WHO, 2019). Compared to the drug sensitive Tuberculosis, first line drug resistant TB or the Multi-Drug Resistant TB (MDR-TB) , patients with second line drug resistance have lower treatment success rate, higher case fatality rates, worse adverse drug events and high treatment cost. In Bhutan, limited studies are available for drug resistant TB. According to the annual drug resistant surveillance report prepared by the National TB Reference Laboratory since 2010 , the number of MDR-TB has been increasing over the years. The proportion of MDR-TB remains high among people without a previous history of TB treatment. In Bhutan, in the last decade; National TB Control Program (NTCP) has worked in the control of MDR-TB and has maintained a treatment success rate above 90% However, there are no reports on the second line drug resistance. |
| Objectives | This study aims to inform regarding the coverage of second line DST in the country in the last 13 years since the inception of drug resistant surveillance in the country and the emergence of the second line drug resistance. For a small population, a single case of XDR-TB would be alarming. Therefore, in this study, we look at the data from 2010 when the first drug resistance surveillance was started in the country and look at the diagnosis of second line drug resistance over the years.The aim of this study is to look at the emergence of second line drug resistant in the country. The specific objectives are to: 1. Describe the timeline of emergence of second line drug resistant TB in Bhutan 2. Assess the diagnostic capacity of second line anti-TB drugs 3. Describe the demographic characteristics and outcomes of Pre-XDR TB & XDR-TB patients 4. Find the association of Pre-XDR TB among the new and previously treated TB cases |
| Study Methods | Study design:Retrospective cross sectional study design will be used for the study Study period:Retrospective data from 2010 until 2023 will be analyzed Sample size:Based on the annual incidence of MDR-TB estimate of 50 cases, 700 cases of MDR-TB will be enrolled. Study Setting:The study will be conducted at the National TB Reference Laboratory at the RCDC. Registers and online databases will be accessed to retrieve the data from 2010-2023 Data collection and management:All TB cases detected as positive using microscopy and GeneXpert were sent to National TB Reference Lab (NTRL) at RCDC for culture and drug sensitivity testing (DST). For this study only the patients diagnosed as MDR-TB will be included. The patient details including demographic details and laboratory reports were entered in the sample shipment form until 2013. From 2014 onwards, the details were entered in the web-based system for TB surveillance hosted at the Royal Centers for Disease Control (RCDC) website. The online system is called the Tuberculosis Information & Surveillance System (TbISS). The data for this study will be extracted as per the study’s objectives from manual registers and online web based systems. For this study, variables such as the age, sex, year of diagnosis and laboratory details will be included (data collection tool attached). Additionally, for the Pre-XDR & XDR-TB cases, the treatment outcome will be collected from the National TB Control Program’s records. |
| Expected outcomes and use of results | This is the first study to highlight the presence of second line drug resistant TB in the country. Due to the severity and transmissibility of this infectious disease, it is crucial to advocate the policy makers and the public on the burden of disease and the public health implications of second line drug resistant TB though evidence based scientific report. |
| Keywords | Secondline drug resistance, Tuberculosis, Surveillance |
Research Details
| Student research | No |
| Start Date | 01-Aug-2024 |
| End Date | 01-Aug-2025 |
| Key Implementing Institution | Royal Centre for Disease Control |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Tuberculosis |
| Involves human subjects | No |
| Data Collection | Secondary data |
| Proposal reviewed by other Committee | No |