Clinical trial NCT03667742: Diagnosing of Acute Tuberculosis
Official title: SwEaTB - Diagnosing of Acute Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: sweat protein markers in tuberculosis
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
timeFrame: Sweat samples taken at baseline and 2 weeks after baseline
measure: Change in protein markers (ESAT-6 and CFP-10 and CRP and Amyloid A2 and C1q) in patients with tuberculosis and other pulmonary diseases
timeFrame: Blood samples taken at baseline and 2 weeks after baseline
Secondary outcomes:
measure: change of protein markers during tuberculostatic therapy
timeFrame: sweat and blood sweat and blood samples taken at baseline and 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis
measure: Differences in protein markers in patients with other pulmonary diseases
timeFrame: sweat and blood samples taken at baseline
measure: Differences in protein markers in patients with positive and negative tuberculosis ELISpot
timeFrame: sweat and blood samples taken at baseline
Other outcomes:
measure: detection of tuberculostatic drug in sweat samples in patients with active tuberculosis during tuberculostatic therapy
timeFrame: sweat samples taken 2 weeks after initiating tuberculostatic therapy in patients with active tuberculosis
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Muttenz
country: Switzerland
facility: Hochschule für Lifescience
Study officials:
affiliation: Chief Clinical Medical Office
name: Jens Eckstein, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: