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transition_easing=”ease” scroll_motion_devices=”small-visibility,medium-visibility,large-visibility” animation_direction=”left” animation_speed=”0.3″ animation_delay=”0″ last=”true” border_position=”all” first=”true” min_height=”” link=””][fusion_title title_type=”text” scroll_reveal_effect=”color_change” scroll_reveal_basis=”chars” scroll_reveal_behavior=”always” scroll_reveal_duration=”500″ scroll_reveal_stagger=”200″ scroll_reveal_delay=”0″ scroll_reveal_above_fold=”yes” marquee_direction=”left” marquee_mask_edges=”no” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”once” highlight_animation_duration=”1500″ highlight_width=”9″ highlight_smudge_effect=”no” highlight_top_margin=”0″ title_link=”off” link_target=”_self” content_align=”left” size=”1″ text_shadow=”no” text_shadow_blur=”0″ text_stroke=”no” text_stroke_size=”1″ text_overflow=”none” gradient_font=”no” gradient_start_position=”0″ gradient_end_position=”100″ 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โครงการนี้เป็นการศึกษาวิจัยระยะที่ 3 (Phase III) แบบเปิดเผยข้อมูล (open-label) ที่ดำเนินการในหลายศูนย์วิจัย (multi-center) โดยใช้การออกแบบการวิจัยแบบ cluster-randomized superiority ซึ่งกลุ่มตัวอย่าง (cluster) หมายถึงสมาชิกในครอบครัวเดียวกันที่สัมผัสกับผู้ป่วย MDR-TB
วัตถุประสงค์หลัก
เพื่อเปรียบเทียบประสิทธิภาพและความปลอดภัยของยา delamanid กับยา isoniazid ที่ให้ต่อเนื่องเป็นเวลา 26 สัปดาห์ ในการป้องกันการเกิดวัณโรค ภายในระยะเวลาเฝ้าติดตาม 96 สัปดาห์ ในกลุ่มผู้สัมผัสความเสี่ยงสูงที่อาศัยอยู่ในบ้านเดียวกับผู้ป่วย MDR-TB
กลุ่มเป้าหมาย
คาดว่าจะมีผู้เข้าร่วมมากกว่า 3,400 ราย จากประมาณ 1,700 ครัวเรือน (โดยเฉลี่ยมีผู้เข้าร่วม 2 รายต่อบ้าน)
ความร่วมมือ
โครงการนี้เป็นความร่วมมือระหว่างเครือข่าย IMPAACT และ ACTG
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