Diagnosing of Acute Tuberculosis

NCT03667742 | Completed

• 1 other identifier: 2017-01455; me17Eckstein2
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Tuberculosis

Keywords

sweat protein markers in tuberculosis

Outcome Measures

Primary Outcomes (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

  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

• 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 Outcomes (3)

• 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

• Differences in protein markers in patients with other pulmonary diseases

  sweat and blood samples taken at baseline

• Differences in protein markers in patients with positive and negative tuberculosis ELISpot

  sweat and blood samples taken at baseline

Other Outcomes (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

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

12 In- patients at University Hospital Basel/ Switzerland with acute tuberculosis 16 In- patients at University Hospital Basel/ Switzerland with other pulmonary diseases (Pneumonia, Bronchitis, COPD) 5 Healthy Donors

You may qualify if:

• 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)
• negative for Quantiferon- TB Gold Plus Test or ELISpot

You may not qualify if:

• Initiation of tuberculostatic therapy before baseline
• Initiation of antibiotic therapy in patients with other pulmonary diseases \> 6 hours before baseline

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

University Hospital Basel

Basel, 4058, Switzerland

Location

Hochschule für Lifescience

Muttenz, 4132, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples, sweat samples

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Jens Eckstein, PD Dr. med

  Chief Clinical Medical Office

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 12, 2018
• Study Start: November 17, 2017
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

CH (2)