Diagnosing of Acute Tuberculosis

NCT ID: NCT03667742

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-17

Study Completion Date

2020-11-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sweat proteins are analysed to investigate differences in protein markers in patients with acute tuberculosis and other pulmonary diseases (pneumonia, Bronchitis, chronic obstructive pulmonary disease (COPD)) and healthy individuals. Differences in sweat protein markers in patients with positive and negative tuberculosis Enzyme-linked-immuno-Spot (EliSpot) are investigated.

Differences in sweat protein markers in the course of treatment in patients receiving tuberculostatic therapy are investigated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sweat protein markers in tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

analysis of sweat and serum samples for protein markers

collection of blood and sweat samples (with Macroduct Sweat Collecting System) in patients with suspected tuberculosis or proven acute tuberculosis or pulmonary diseases (pneumonia, bronchitis, COPD) and analyzing serum and sweat for protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) by mass spectrometry and enzyme-linked immunosorbent assay (ELISA)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients
* Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
* In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)


* negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria

* Initiation of tuberculostatic therapy before baseline
* Initiation of antibiotic therapy in patients with other pulmonary diseases \> 6 hours before baseline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jens Eckstein, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

Chief Clinical Medical Office

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Basel

Basel, , Switzerland

Site Status

Hochschule für Lifescience

Muttenz, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-01455; me17Eckstein2

Identifier Type: -

Identifier Source: org_study_id