SwEaTB: Diagnosing of Acute Tuberculosis

• Sponsor: University Hospital, Basel, Switzerland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03667742
• Collaborator: (none)
• Enrollment: 35
• Locations: 2
• Actual Duration (Months): 35.6
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Diagnostic Test: analysis of sweat and serum samples for protein markers

Study Design

• Study Type: Observational
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: SwEaTB - Diagnosing of Acute Tuberculosis
• Actual Study Start Date: Nov 17, 2017
• Actual Primary Completion Date: Nov 4, 2020
• Actual Study Completion Date: Nov 4, 2020

Outcome Measures

Primary Outcome Measures

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 [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 [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

1. 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).

2. 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).

3. 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).

Other Outcome Measures

1. detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapy [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Basel	Basel		Switzerland	4058
2	Hochschule für Lifescience	Muttenz		Switzerland	4132

Sponsors and Collaborators

• University Hospital, Basel, Switzerland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Basel, Switzerland
• ClinicalTrials.gov Identifier: NCT03667742
• Other Study ID Numbers: 2017-01455; me17Eckstein2
• First Posted: Sep 12, 2018
• Last Update Posted: Dec 1, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Basel, Switzerland: sweat protein markers in tuberculosis
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Dec 1, 2020