2017 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 already been recruiting patients and established the plasma leakage outcome measurement using ultrasound method. There are no severe side effects in the dengue patients. In addition, we frequently communicate with the Vietnamese researchers using several platforms including Skype, Lines, Viber, Facebook, Emails and Telephone.
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| Strategy for Future Research Activity |
We will finish the enrollment of dengue patients this year. 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).
Finally data will be analyzed and prepared to submit to the peer review journal.
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Research Products
(3 results)
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[Journal Article] Definitions for Warning Signs and Signs of Severe Dengue According to The WHO 2009 Classification: Systematic Review of Literature2018
Author(s)
Morra ME, Altibi AM, Iqtadar S, Minh LHN, Elawady SS, Hallab A, Elshafay A, Omer OA, Iraqi A, Adhikari P, Labib JH, Elhusseiny KM, Elgebaly A, Yacoub S, Huong LTM, Hirayama K, Huy NT
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Journal Title
Reviews in Medical Virology
Volume: April
Pages: e1979
DOI
Peer Reviewed / Int'l Joint Research
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[Journal Article] Post-dengue acute disseminated encephalomyelitis: A case report and meta-analysis2017
Author(s)
Kamel MG, Nam NT, Han NHB, El-Shabouny AE, Makram AM, Abd-Elhay FA, Dang TN, Hieu NLT, Huong VTQ, Tung TH, Hirayama K, Huy NT
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Journal Title
PLoS Negl Trop Dis
Volume: 11(6)
Pages: e0005715
DOI
Peer Reviewed / Int'l Joint Research
