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Prospective Surveillance of Febrile Illness for Dengue-Endemic Areas in Asia

11 januari 2018 bijgewerkt door: Sanofi

The purpose of this study is to detect acute febrile episodes and dengue infection in five Asian countries, to assess dengue seroprevalence, and to assess surveillance infrastructure at investigational sites in anticipation of a Phase 3 efficacy trial of a vaccine to prevent dengue infection.

The primary objectives are:

To identify acute febrile episodes among the cohort in order to detect the presence of dengue infection.
To develop operational infrastructure for potential Phase III dengue efficacy trial sites.
To describe the dengue seroprevalence among the cohort at baseline and at the end of the study.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

All participants will make two visits to a study site, an enrollment visit and a termination visit. Additional visits will be made if febrile episodes occur: an acute visit and a convalescent visit. Participants or their parents/guardians will be contacted weekly to monitor the occurrence of febrile episodes and ensure appropriate assessment and care.

No vaccine will be provided or administered in this study.

Studietype

Observationeel

Inschrijving (Werkelijk)

1500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Filippijnen
- - Cebu City, Filippijnen, 6000
  - Muntinlupa City, Filippijnen
  - San Pablo, Filippijnen
Indonesië
- - Bali, Indonesië
  - Bandung, Indonesië, 40161
  - Jakarta, Indonesië, 10430
Maleisië
- - Kuala Lumpur, Maleisië
  - Penang, Maleisië
  - Putrajaya, Maleisië
Thailand
- - Bangkok, Thailand, 10400
Vietnam
- - My Tho City, Vietnam

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 14 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Participants aged 2 to 14 years in 5 countries in Asia: Malaysia, Indonesia, Thailand, the Philippines and Viet Nam.

Beschrijving

Inclusion Criteria :

Aged 2 to 14 years on the day of inclusion and resident of the site zone
Subject in good health, based on medical history and physical examination
Assent form has been signed and dated by the subject (if required by local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by the subject and/or an independent witness if required by local regulations)
Subject able to attend all scheduled visits and to comply with all study procedures
For a female of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to enrollment.

Exclusion Criteria :

Known pregnancy at the Enrollment Visit
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding enrollment
Planned participation in another clinical trial during the present study period
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with study procedures
Receipt of blood or blood-derived products in the past 3 months
Receipt of any vaccine in the 4 weeks preceding the day of enrollment except for pandemic influenza vaccination, which may be received at least 2 weeks before enrollment
Planned receipt of any vaccine in the 4 weeks following enrollment
Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.

Temporary Contraindications

A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:

Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of enrollment.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Prospectief

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Cohort Population (Case ) Participants will be examined for febrile illness to diagnose dengue and to identify common causes of fever.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Tijdsspanne
To provide information on the incidences of febrile episodes and confirmed and probable Dengue fever, and to determine other causes of febrile episodes in the cohort population Tijdsspanne: Up to 12 months after enrollment	Up to 12 months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sanofi

Onderzoekers

Studie directeur: Medical Director, Sanofi Pasteur SA.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Capeding MR, Chua MN, Hadinegoro SR, Hussain II, Nallusamy R, Pitisuttithum P, Rusmil K, Thisyakorn U, Thomas SJ, Huu Tran N, Wirawan DN, Yoon IK, Bouckenooghe A, Hutagalung Y, Laot T, Wartel TA. Dengue and other common causes of acute febrile illness in Asia: an active surveillance study in children. PLoS Negl Trop Dis. 2013 Jul 25;7(7):e2331. doi: 10.1371/journal.pntd.0002331. Print 2013.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2010

Primaire voltooiing (Werkelijk)

1 november 2011

Studie voltooiing (Werkelijk)

1 maart 2012

Studieregistratiedata

Eerst ingediend

8 oktober 2010

Eerst ingediend dat voldeed aan de QC-criteria