Case definitions for dengue were first developed using clinical experiences from dengue outbreaks involving children in Southeast Asia. The case definitions were published in the World Health Organization (WHO) technical guide in 1975 and updated in 1997. The WHO 1997 classification offers the possibility of grading of the severity of dengue cases. In November 2009, a new dengue case classification using a set of clinical and/or laboratory parameters was released by WHO to improve clinical management and surveillance across the globe in all settings, regardless of resources.
The value of a standardized dengue clinical case classification system
The workshop’s main objective was to reach consensus on a dengue clinical case classification (DCCC) system for moderate and severe dengue to be used in pathogenesis studies and/or intervention trials. Standardized definitions are very important to help ensure complete, accurate and harmonized classification of cases to monitor the long-term safety and effectiveness of dengue vaccines and to compare interventions. Currently, manufacturers use their own endpoints for severity.
Contributing to more targeted clinical research on dengue
The WHO case definitions established in 2009 are widely applied in endemic countries for case detection, patient triage and clinical management. However, they are of limited use in clinical research, especially as regards criteria for severe disease.
The workshop addressed this challenge by developing a refined clinical case classification for moderate and severe dengue that can be applied in interventional trials and pathogenesis studies as secondary endpoints. Case definitions are to be used to classify study subjects who are being monitored as part of an interventional trial or pathogenesis study and who meet the primary efficacy endpoint (i.e., two days of fever plus laboratory-confirmed DENV infection).
Workshop outcomes
Although the final definition of a proposed clinical case classification for clinical trials was not reached, workshop participants made progress in the identification of clinical and laboratory parameters to clearly approach a consensus about the definition of severe dengue. After the April workshop, a follow-up meeting was planned to coincide with the 64th Annual Meeting of the American Society of Tropical Medicine and Hygiene, October 25-29 2015.
At this follow-up workshop, held in Philadelphia on October 29, participants continued to move forward to reach consensus about clinical trial endpoints for the purpose of measuring the efficacy of dengue interventions on disease severity.
Assessing the impact of PDC’s holistic approach
Improving the comparability of data obtained from interventional trials and pathogenesis studies is particularly useful for the purpose of measuring the impact of PDC’s integrated vaccine intervention and vector control approach and to accurately assess the clinical benefit of a vaccine or drug. Standardization was requested during the Mexico meeting on surveillance. Comparability between interventions is a key step for assessing public health strategies.
Session V: Defining dengue severity markers: organ involvement
Liver and gastrointestinal tract (Kay Tomashek)
Central nervous system and lung (Lucy Lum and Laurent Thomas)
Muscle, heart, and kidney (Laurent Thomas and Anna Durbin)
13h00 – 14h00
Session VI: Plans to evaluate a refined dengue clinical case definition (Thomas Jänisch and João Bosco Siqueira)
14h30 – 16h30
Session VII: Summary and next steps (Walla Dempsey and Stephen Thomas)
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Case definitions for dengue were first developed using clinical experiences from dengue outbreaks involving children in Southeast Asia. The case definitions were published in the World Health Organization (WHO) technical guide in 1975 and updated in 1997. The WHO 1997 classification offers the possibility of grading of the severity of dengue cases. In November 2009, a new dengue case classification using a set of clinical and/or laboratory parameters was released by WHO to improve clinical management and surveillance across the globe in all settings, regardless of resources.
The value of a standardized dengue clinical case classification system
The workshop’s main objective was to reach consensus on a dengue clinical case classification (DCCC) system for moderate and severe dengue to be used in pathogenesis studies and/or intervention trials. Standardized definitions are very important to help ensure complete, accurate and harmonized classification of cases to monitor the long-term safety and effectiveness of dengue vaccines and to compare interventions. Currently, manufacturers use their own endpoints for severity.
Contributing to more targeted clinical research on dengue
The WHO case definitions established in 2009 are widely applied in endemic countries for case detection, patient triage and clinical management. However, they are of limited use in clinical research, especially as regards criteria for severe disease.
The workshop addressed this challenge by developing a refined clinical case classification for moderate and severe dengue that can be applied in interventional trials and pathogenesis studies as secondary endpoints. Case definitions are to be used to classify study subjects who are being monitored as part of an interventional trial or pathogenesis study and who meet the primary efficacy endpoint (i.e., two days of fever plus laboratory-confirmed DENV infection).
Workshop outcomes
Although the final definition of a proposed clinical case classification for clinical trials was not reached, workshop participants made progress in the identification of clinical and laboratory parameters to clearly approach a consensus about the definition of severe dengue. After the April workshop, a follow-up meeting was planned to coincide with the 64th Annual Meeting of the American Society of Tropical Medicine and Hygiene, October 25-29 2015.
At this follow-up workshop, held in Philadelphia on October 29, participants continued to move forward to reach consensus about clinical trial endpoints for the purpose of measuring the efficacy of dengue interventions on disease severity.
Assessing the impact of PDC’s holistic approach
Improving the comparability of data obtained from interventional trials and pathogenesis studies is particularly useful for the purpose of measuring the impact of PDC’s integrated vaccine intervention and vector control approach and to accurately assess the clinical benefit of a vaccine or drug. Standardization was requested during the Mexico meeting on surveillance. Comparability between interventions is a key step for assessing public health strategies.
Case definitions for dengue were first developed using clinical experiences from dengue outbreaks involving children in Southeast Asia. The case definitions were published in the World Health Organization (WHO) technical guide in 1975 and updated in 1997. The WHO 1997 classification offers the possibility of grading of the severity of dengue cases. In November 2009, a new dengue case classification using a set of clinical and/or laboratory parameters was released by WHO to improve clinical management and surveillance across the globe in all settings, regardless of resources.
The value of a standardized dengue clinical case classification system
The workshop’s main objective was to reach consensus on a dengue clinical case classification (DCCC) system for moderate and severe dengue to be used in pathogenesis studies and/or intervention trials. Standardized definitions are very important to help ensure complete, accurate and harmonized classification of cases to monitor the long-term safety and effectiveness of dengue vaccines and to compare interventions. Currently, manufacturers use their own endpoints for severity.
Contributing to more targeted clinical research on dengue
The WHO case definitions established in 2009 are widely applied in endemic countries for case detection, patient triage and clinical management. However, they are of limited use in clinical research, especially as regards criteria for severe disease.
The workshop addressed this challenge by developing a refined clinical case classification for moderate and severe dengue that can be applied in interventional trials and pathogenesis studies as secondary endpoints. Case definitions are to be used to classify study subjects who are being monitored as part of an interventional trial or pathogenesis study and who meet the primary efficacy endpoint (i.e., two days of fever plus laboratory-confirmed DENV infection).
Workshop outcomes
Although the final definition of a proposed clinical case classification for clinical trials was not reached, workshop participants made progress in the identification of clinical and laboratory parameters to clearly approach a consensus about the definition of severe dengue. After the April workshop, a follow-up meeting was planned to coincide with the 64th Annual Meeting of the American Society of Tropical Medicine and Hygiene, October 25-29 2015.
At this follow-up workshop, held in Philadelphia on October 29, participants continued to move forward to reach consensus about clinical trial endpoints for the purpose of measuring the efficacy of dengue interventions on disease severity.
Assessing the impact of PDC’s holistic approach
Improving the comparability of data obtained from interventional trials and pathogenesis studies is particularly useful for the purpose of measuring the impact of PDC’s integrated vaccine intervention and vector control approach and to accurately assess the clinical benefit of a vaccine or drug. Standardization was requested during the Mexico meeting on surveillance. Comparability between interventions is a key step for assessing public health strategies.
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