Diagnosing of Acute Tuberculosis (SwEaTB)

November 30, 2020 updated by: University Hospital, Basel, Switzerland

SwEaTB - Diagnosing of Acute Tuberculosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4058
        • University Hospital Basel
      • Muttenz, Switzerland, 4132
        • Hochschule für Lifescience

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

12 In- patients at University Hospital Basel/ Switzerland with acute tuberculosis 16 In- patients at University Hospital Basel/ Switzerland with other pulmonary diseases (Pneumonia, Bronchitis, COPD) 5 Healthy Donors

Description

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)

Inclusion Criteria Healthy Donors:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
Time Frame: Sweat samples taken at baseline and 2 weeks after baseline
Distinction of patients with acute tuberculosis from patients with other pulmonary diseases by 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)). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
Sweat samples taken at baseline and 2 weeks after baseline
Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
Time Frame: Blood samples taken at baseline and 2 weeks after baseline
Distinction of patients with acute tuberculosis from patients with other pulmonary diseases by 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)). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
Blood samples taken at baseline and 2 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of protein markers during tuberculostatic therapy
Time Frame: sweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis
Analysis of 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)) during tuberculostatic therapy. Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
sweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis
Differences in protein markers in patients with other pulmonary diseases
Time Frame: sweat and blood samples taken at baseline
Analysis and comparison of 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)) in patients with other pulmonary diseases (pneumonia, Bronchitis, COPD). Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
sweat and blood samples taken at baseline
Differences in protein markers in patients with positive and negative tuberculosis ELISpot
Time Frame: sweat and blood samples taken at baseline
Analysis and comparison of 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)) in patients with positive and negative tuberculosis ELISpot. Analysis done by mass spectrometry and enzyme linked immunosorbent assay (ELIZA).
sweat and blood samples taken at baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapy
Time Frame: sweat samples taken 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis
Analysis of sweat protein markers in patients with active tuberculosis during tuberculostatic therapy
sweat samples taken 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Jens Eckstein, PD Dr. med, Chief Clinical Medical Office

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2017

Primary Completion (ACTUAL)

November 4, 2020

Study Completion (ACTUAL)

November 4, 2020

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (ACTUAL)

September 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01455; me17Eckstein2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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