NCT02115854

Brief Summary

The distinction between Tuberculosis disease (TB), a worldwide infective granulomatosis requiring long-term antibiotic treatment, and sarcoïdosis, a rare granulomatous disease successfully treated with high dose steroids is not straightforward and may delay the treatment choice by the physician. The goal was to evaluate prospectively and consecutively the presence of epithelioid granulomas in salivary glands biopsy of patients with TB.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

3.3 years

First QC Date

April 10, 2014

Last Update Submit

April 15, 2014

Conditions

TuberculosisSarcoidosis

Keywords

usefullness of labial biopsy to distinguish between tuberculosis and sarcoidosis

Outcome Measures

Primary Outcomes (1)

  • presence of granuloma on labial biopsy

    at day zero of treatment of tuberculosis

Study Arms (1)

bacteriologically confirmed tuberculosis

Other: labial biopsy

Interventions

labial biopsyOTHER
bacteriologically confirmed tuberculosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

bacteriologically confirmed tuberculosis

You may qualify if:

  • adults above 18 years,
  • bacteriologically confirmed tuberculosis

You may not qualify if:

  • patient not able to sign written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unite de Recherche Thérapeutique

Paris, 75010, France

Location

MeSH Terms

Conditions

TuberculosisSarcoidosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 16, 2014

Study Start

December 1, 2010

Primary Completion

April 1, 2014

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

FR(1)