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Diagnosing of Acute Tuberculosis

SwEaTB - Diagnosing of Acute Tuberculosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03667742
Acronym
SwEaTB
Enrollment
35
Registered
2018-09-12
Start date
2017-11-17
Completion date
2020-11-04
Last updated
2020-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

sweat protein markers in tuberculosis

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.

Interventions

DIAGNOSTIC_TESTanalysis 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)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseasesSweat samples taken at baseline and 2 weeks after baselineDistinction 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

MeasureTime frameDescription
change of protein markers during tuberculostatic therapysweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosisAnalysis 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 other pulmonary diseasessweat and blood samples taken at baselineAnalysis 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).
Differences in protein markers in patients with positive and negative tuberculosis ELISpotsweat and blood samples taken at baselineAnalysis 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

MeasureTime frameDescription
detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapysweat samples taken 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosisAnalysis of sweat protein markers in patients with active tuberculosis during tuberculostatic therapy

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026