Diagnosing of Acute Tuberculosis

Tuberculosis Clinical Trial

— SwEaTB  

Official title:

SwEaTB - Diagnosing of Acute Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667742
• Other study ID #: 2017-01455; me17Eckstein2
• Status: Completed
• Start date: November 17, 2017
• Est. completion date: November 4, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 4, 2020
• Est. primary completion date: November 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	Hochschule für Lifescience	Muttenz

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapy	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
Primary	Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases	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
Primary	Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases	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	change of protein markers during tuberculostatic therapy	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
Secondary	Differences in protein markers in patients with other pulmonary diseases	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
Secondary	Differences in protein markers in patients with positive and negative tuberculosis ELISpot	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