Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Intensifying Multi-Drug Resistant Tuberculosis Contact Tracing by Social Network Analysis (SNAP)

13 novembre 2016 mis à jour par: Oxford University Clinical Research Unit, Vietnam

Contact Tracing by Social Network Analysis to Enhance Multi-Drug Resistant Tuberculosis Case Finding in Hanoi, Vietnam

Tuberculosis burden in Vietnam increasing with contribution from low detection rates and increased drug resistance. There is a need to identify MDR-TB (MultiDrug Resistant Tuberculosis) among both notified TB cases and their contacts in the community. Traditional contact tracing often focuses on household contacts while strains of TB circulate in homes, schools, workplaces, and beyond. Social network Analysis (SNA) is a comprehensive approach which includes a set of persons and the connections among them used for analysis of structure of disease transmission.

In this study, SNA will be used to collect network data from 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi, and to identify and test potential MDR-TB cases.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The study will identify and recruit 60 newly detected Rifampicin resistant TB patients including an expected 50 MDR-TB patients living in Hanoi (index cases) who will undergo SNA of contacts and places they have stayed during 3 months preceding their TB diagnosis including residence, travel history, places of social aggregation in relation with their risk behaviour.

Patients will be interviewed to investigate contacts before the confirmation of MDR-TB (for early contact detection and minimize the risk of information lost due to patient default during treatment). Data analysis will focus on MDR-TB social networks using Cytoscape software.

After the first two enrolled Rifampicin resistant MDR-TB cases, social network data will be analyzed to identify close contacts, mutual contacts, mutual places and high risk locations. The Social Network Questionnaire (SNQ) will be contextualized to the Vietnamese setting and validated in a pilot study. Eligible contacts and locations will undergo MDR-TB screening.

Approximately 720 contacts will undergo active screening (on 2 occasions per individual: at the time of contact identification and 6 months later). Contacts will include household contacts, close contacts, mutual contacts and symptomatic individuals with significant exposure to the index case at mutual locations within a closed environment.

Contact screening will involve clinical assessment, chest X-ray and sputum or gastric aspirate collection for TB culture, molecular techniques and microbiological identification.

If contacts are screened and detected as having Rifampicin resistant TB, they will be invited to be included in SNA for further analysis.

The number of MDR-TB detected by SNA will determine whether transmission of MDR-TB not otherwise detected by routine contact investigation (only household contact tracing) is important. While traditional contact tracing practices in Vietnam mainly focus on household contacts to detect secondary cases of TB, this SNA is expected not only to identify secondary cases of MDR-TB within an extended catchment but to also identify the source cases of MDR-TB patients to " turn off the tap" of MDR-TB transmission. Moreover, the places identified as the sources of sustained transmission will be targeted for case finding along with appropriate resource allocation.

In this study analysis will focus on the costs of contact tracing with Social Network Questionnaires, the proportion of MDR-TB among eligible contacts by subgroup, the proportion of MDR-TB among Rifampicin resistant TB patients and the genotyping pattern of MDR -TB patients.

Type d'étude

Observationnel

Inscription (Réel)

596

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

      • Hanoi, Viêt Nam, 10000
        • National Lung Hospital

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

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with newly detected rifampicin resistant TB or MDR-TB and their contacts

La description

Inclusion Criteria:

  • PATIENTS: Newly detected rifampicin resistant TB or MDR-TB patients living in Hanoi for at least 3 months preceding a diagnosis made between 2013-2015.
  • CONTACTS: During the 3 months before the patient's TB or MDR-TB diagnosis: all persons who spend an average of >4 hours per day in the same residence as the patient AND/OR any individual who has had frequent and prolonged contact with the patient AND/OR anyone who has spent time in a closed environment with an MDR-TB patient
  • PATIENTS AND CONTACTS: All ages
  • PATIENTS AND CONTACTS: Living in Hanoi during the study period.

Exclusion Criteria:

-PATIENTS AND CONTACTS: Lack of informed consent for participation.

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

Cohortes et interventions

Groupe / Cohorte
Drug resistant TB patients
Patients with rifampicin resistant TB or MDR-TB newly confirmed by drug susceptibility tests (DST)
Contacts
Contacts of patients with newly detected rifampicin resistant TB or MDR-TB in households, schools, workplaces and other locations.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Yield of MDR-TB case detection through SNA
Délai: Six months
The number of MDR-TB cases notified from contacts identified by SNA and who would not have been detected by routine screening.
Six months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
MDR-TB incidence among subgroups of contacts
Délai: Six months
The proportion of MDR-TB among eligible contacts by subgroup (household contacts, close contacts, mutual contacts, eligible contacts from mutual places with closed environment).
Six months
MDR-TB incidence among rifampicin resistant TB cases
Délai: Six months
Incidence of MDR-TB confirmed by drug susceptibility tests (DST) among rifampicin resistant TB patients.
Six months
MDR-TB genotype
Délai: Six months
Consistency or difference between TB genotype of enrolled MDR-TB patients and contacts/secondary cases.
Six months
Cost-effectiveness ratio of SNA and passive case finding strategies
Délai: Six months
The incremental cost-effectiveness ratio (ICERs) between SNA and passive case finding for one MDR-TB case detected (i.e, the cost of SNA minus the cost of passive case finding divided by the yield in terms of case detection of SNA minus the yield of passive CF)
Six months

Collaborateurs et enquêteurs

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

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.

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 décembre 2013

Achèvement primaire (Réel)

1 septembre 2015

Achèvement de l'étude (Réel)

1 octobre 2015

Dates d'inscription aux études

Première soumission

25 juin 2014

Première soumission répondant aux critères de contrôle qualité

25 juin 2014

Première publication (Estimation)

26 juin 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 novembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 novembre 2016

Dernière vérification

1 juillet 2014

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Infection tuberculeuse

3
S'abonner