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

11 janvier 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

1500

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Indonésie
- - Bali, Indonésie
  - Bandung, Indonésie, 40161
  - Jakarta, Indonésie, 10430
Malaisie
- - Kuala Lumpur, Malaisie
  - Penang, Malaisie
  - Putrajaya, Malaisie
Philippines
- - Cebu City, Philippines, 6000
  - Muntinlupa City, Philippines
  - San Pablo, Philippines
Thaïlande
- - Bangkok, Thaïlande, 10400
Viêt Nam
- - My Tho City, Viêt Nam

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

2 ans à 14 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Délai
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 Délai: Up to 12 months after enrollment	Up to 12 months after enrollment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sanofi

Les enquêteurs

Directeur d'études: Medical Director, Sanofi Pasteur SA.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 août 2010

Achèvement primaire (Réel)

1 novembre 2011

Achèvement de l'étude (Réel)

1 mars 2012

Dates d'inscription aux études

Première soumission

8 octobre 2010

Première soumission répondant aux critères de contrôle qualité