NCT05568368

Brief Summary

determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission

Trial Health

87
On Track

Trial Health Score

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

Enrollment
705

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 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

March 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 4, 2022

Last Update Submit

October 4, 2022

Conditions

Pulmonary Tuberculoses

Outcome Measures

Primary Outcomes (2)

  • tuberculosis transmission

    duration of Tuberculosis transmission between an infected person and a contact case

    2 months

  • contact case tracking

    screening time for contact cases

    2 months

Study Arms (1)

Index cases

Other: No intervention

Interventions

No interventionOTHER

no intervention

Index cases

Eligibility Criteria

Age2 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of bacteriology of Nice University Hospital, and that was positive in culture before treatment and of which contact cases were explored by the CLAT

You may qualify if:

  • have at least 1 contact case explored for tuberculosis
  • latent tuberculosis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 5, 2022

Study Start

March 15, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

October 5, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)