2016 Fiscal Year Annual Research Report
Effects and Safety of Oral Mast Cells Stabilization Therapy in Early Dengue Patients: A Randomized, Placebo-Controlled Trial
| Project/Area Number |
16H05844
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| Research Institution | Nagasaki University |
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Principal Investigator |
グエン フイティエン 長崎大学, 熱帯医学研究所, 准教授 (20457526)
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| Co-Investigator(Kenkyū-buntansha) |
ローサボーン チャントラ 長崎大学, 熱帯医学研究所, 教授 (10640196)
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| Project Period (FY) |
2016-04-01 – 2019-03-31
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| Keywords | Dengue / Clinical trial / Ultrasound |
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| Outline of Annual Research Achievements |
To quantify the treatment efficacy for dengue clinical trial, a standard measurement of dengue severity is needed. We have been conducted a pilot of clinical trial and set up the standard measurement of plasma leakage, which is the main distinguishing feature of dengue severity which can lead to the loss of intravascular volume and circulatory insufficiency. The degree of plasma leakage varies between individual patients depending on the severity of each case which may cause depletion of intravascular volume with the need to fluid resuscitation. Current methods for measuring plasma leakage have several limitations such as unreliability, laborious, and invasiveness. US allows a clinician to detect capillary leakage in the form of pleura; effusion and ascites as well as hepatomegaly, splenomegaly, and thickening of the gallbladder wall in patients with dengue. However, there is no study investigating the reproducibility of US in plasma leakage diagnosis neither in dengue nor in non-dengue patients. We have performed a systematic review to set up a standardized US method. A clinical study has been conducted to assess the reproducibility of US in the assessment of gallbladder-wall thickness in addition to the volume of pleural effusion and ascites as a consequence of plasma leakage in dengue children. Our results indicate good intra- and inter-observer agreement for US measurement in both dengue and non-dengue children.
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| Current Status of Research Progress |
Current Status of Research Progress
1: Research has progressed more than it was originally planned.
Reason
We have successfully established a standard measurement of dengue severity using sonography with good intra- and inter-observer agreements. Our team are working well in the enrollment and taking care of the patient. In conclusion,
we are in a good position to finish the study on time.
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| Strategy for Future Research Activity |
We are enrolling dengue patients with a positive rapid test for dengue non-structural protein 1. Patients will be assigned to one of three treatment arms and treated in 5 days. The dosage for all three arms (Ketotifen: 1mg/tablet; Cetirizine: 10mg/tablet; and Placebo). Patients will be followed by study clinician daily until day 7 of illness. All clinical and laboratory signs will be monitored and recorded in the case report form (CRF) to identify the warning and severe signs. Abdominal and thoracic ultrasound will be performed on day 6 to quantify the plasma leakage level. Clinical treatment will be completely decided by the Hospital clinicians according to the 2009 WHO guidelines. Hematocrit and platelet count will be measured daily or more frequently if necessary. These tests will be repeated at the follow-up visit. Routine laboratory test, electrolytes and coagulation profiles, and renal and liver function tests will be performed at enrolment, day 5 or 6 of illness, and at the follow-up visit. Conventional serological and virological tests will be used to confirm dengue infection and identification of the infecting serotype. A follow-up visit for baseline review and blood sampling after 28 days from enrollment is required for all patients. All adverse events will be recorded on CRF and promptly reported to the independent data and safety monitoring board (DSMB).
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Research Products
(4 results)
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[Presentation] Epidemiology, clinical characteristics, and sequelae of Zika infection. A systematic review and meta-analysis.2017
Author(s)
Huy NT, Giang HN, Alabd S, Ghozy S, Linh LK, Nguyen DPN, Anh TM, Dang NP, Turk T, Hassan M, AbdElsalam ES, Onyeudo O, Nasef S, Sassy A, Hadad HE, Aly S, Hirayama K
Organizer
Australasian Society for Infectious Diseases (ASID). Annual Scientific Meeting.
Place of Presentation
Blue Mountain, Sydney, Australia
Year and Date
2017-03-29 – 2017-04-01
Int'l Joint Research
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[Presentation] Drug discovery2016
Author(s)
Nguyen Tien Huy
Organizer
Seminar; invited by VN-UK Institute for Research & Executive Education, The University of Danang
Place of Presentation
The University of Danang, Da Nang, Vietnam
Year and Date
2016-10-03
Invited
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