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OpenTrials
Completed

NCT Number: NCT03667742

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analysis of sweat and serum samples for protein markers

Diagnostic Test

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)

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

SwEaTB - Diagnosing of Acute Tuberculosis

Acronym: SwEaTB

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2018
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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