Diagnosing of Acute Tuberculosis

Completed

• Conditions: Tuberculosis

• Registration Number: NCT03667742
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-17
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Status Verified: 2020-11
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases	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 Outcome Measures

Name	Time	Method
Differences in protein markers in patients with other pulmonary diseases	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).
change of protein markers during tuberculostatic therapy	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).
Differences in protein markers in patients with positive and negative tuberculosis ELISpot	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).

Trial Locations

Locations (2)

Hochschule für Lifescience; 🇨🇭 Muttenz, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland