| 研究課題/領域番号 |
17H04662
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| 研究機関 | 長崎大学 |
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研究代表者 |
コックス シャーロン 長崎大学, 熱帯医学・グローバルヘルス研究科, 教授 (80750140)
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| 研究分担者 |
柳原 克紀 長崎大学, 医歯薬学総合研究科(医学系), 教授 (40315239)
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| 研究期間 (年度) |
2017-04-01 – 2020-03-31
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| キーワード | Tuberculosis / Malnutrition / Diabetes / immune function / patient costs / psychosocial health |
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| 研究実績の概要 |
Recruitment is ongoing with 437 of the planned 800 enrolled in 11 sites. Study drop out rate is low (N=20)with 87 patients completed TB treatment and follow-up.
S Cox was an invited speaker at the recent Asian Pacific Region Union against TB and Lung Disease Conference in Manila , April 2019 on diagnosis and management of diabetes in Filipino TB patients using data from this study and also at the World Congress in October 2018 at the Hague, Netherlands.
Three PhD students (2 x Nagasaki/London school of Hygiene & Tropical Medicine, UK Joint PhD, WISE scholarships and 1 x NU student) are ongoing within this research project.
The cohort infrastructure is also supporting the recruitment of TB household contacts and TB patients for a further PhD study on immune responses to none TB antigens.
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| 現在までの達成度 (区分) |
現在までの達成度 (区分)
4: 遅れている
理由
Patient enrolment was delayed - please see the reasons given from last years report. It is not possible to "catch up" the time lost and a further 2 month delay was incurred before recruitment started in Aug 2018. There were large delays in recruitment at one site in Manila (SLH) and lower than expected enrolment at this site, in part due to changes in National TB Programme Policy for tertiary hospital sites. However, recruitment at the other sites and data collection is progressing smoothly and at or above target.
Enrolment of drug resistant patients is below expected numbers due to a nation-wide stock out of gene Xpert cartridges for drug resistance testing and limited/no culture facilities in our sites. Also many sites are still not enrolling DR-TB cases on the WHO - shorter regimen, despite it being national policy for those that meet the inclusion criteria for this treatment regimen.
We needed to change the direct cost breakdown as we employed staffs and purchased consumables by ourselves due to the unavailability for the planned sub-contract, which caused another delay.
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| 今後の研究の推進方策 |
Data collection as described in last years plan will continue this year. Additional data collection on depression, social family support, stigma and TB treatment adherence started in October 2018 supporting PhD projectt. Ppatient cost data collection is progressing well with almost 100% uptake.
Lab analysis of archived QFT supernatants is planned from October 2019.
Patient enrolment for DS-TB is expected to complete in July/Aug2019 - within the planned enrolment period. The last patient should complete follow-up in July 2020, and majority on 6 or 9 months treatment complete follow-up by Dec 19/March 20.
We are currently seeking further funding to support the cohort after this FY to continue follow up for post-treatment outcomes (lung function including spirometry and risk of relapse TB.
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