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Trial record 80 of 97 for:    "Dengue Hemorrhagic Fever"

A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia

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ClinicalTrials.gov Identifier: NCT02570152
Recruitment Status : Recruiting
First Posted : October 7, 2015
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Ministry of Health, Sri Lanka
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.

Condition or disease Intervention/treatment Phase
Dengue Procedure: Blood sample collection Not Applicable

Detailed Description:

This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials.

Operational goals include:

  • Build long-term collaboration with sites in dengue-endemic regions of South Asia where the incidence of clinical dengue illness can be studied.
  • Establish dengue surveillance cohorts that can be followed long-term.
  • Establish operational feasibility of future Phase III studies with regard to recruitment, case capture and sampling procedures.
  • Prepare sites for participation in Phase III clinical endpoint studies.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Cohort Study to Determine the Incidence of Dengue Fever and to Build Capacity for Dengue Vaccine Trials in Dengue-endemic Regions of South Asia
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : July 29, 2019
Estimated Study Completion Date : July 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever

Arm Intervention/treatment
Experimental: AFI Group
Population living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years will be considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consent (and assent if applicable) to participate in the study.
Procedure: Blood sample collection
Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever [body temperature ≥ 38°C/≥ 100.4°F] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).




Primary Outcome Measures :
  1. Occurrence of Acute febrile illness (AFI) due to Laboratory Confirmed Dengue (LCD). [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]
    An AFI due to LCD was confirmed if all of the following criteria were met: • Fever (body temperature ≥ 38°C/≥ 100.4°F) recorded or reported on ≥ 2 consecutive calendar days, measured at least twice, at least 812 hours apart, • Laboratory confirmation of dengue through dengue RT-qPCR on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) • Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) is valid and for dengue.


Secondary Outcome Measures :
  1. Occurrence of AFI due to non-LCD. [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]
    An AFI due to non-LCD was confirmed if all of the following criteria were met: • Fever (body temperature ≥ 38°C/≥ 100.4°F) recorded or reported on ≥ 2 consecutive calendar days, measured at least twice, at least 812 hours apart, and • Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) is (valid but) negative for dengue.

  2. Occurrence of AFI due to LCD by DENV type, study site, and age group. [ Time Frame: At Month 24 (from Visit 1 to Visit 2) ]


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Ages Eligible for Study:   6 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.).
  • Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness.
  • Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child.
  • Male or female aged between and including 6 months and 50 years at the time of enrolment.
  • Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period.

Exclusion Criteria:

  • Child in care.
  • Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
  • Terminal illness based on investigator's judgement.
  • Mental incapacity based on investigator's judgement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570152


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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India
GSK Investigational Site Withdrawn
Delhi, India, 110002
GSK Investigational Site Withdrawn
Puducherry, India, 605014
GSK Investigational Site Withdrawn
Thiruvananthapuram, Kerala, India, 695011
Sri Lanka
GSK Investigational Site Recruiting
Colombo, Sri Lanka
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Hasitha Tissera         
Sponsors and Collaborators
GlaxoSmithKline
Ministry of Health, Sri Lanka
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02570152     History of Changes
Other Study ID Numbers: 200274
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019

Keywords provided by GlaxoSmithKline:
Dengue
Non-laboratory confirmed dengue (non-LCD)
Acute febrile illness (AFI)
Laboratory confirmed dengue (LCD)

Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral