Prevalence of non-tuberculous infections in patientswith presumed tuberculosis disease in Gabon – a proof-of-principle study
- Conditions
- A15.9Respiratory tuberculosis unspecified, confirmed bacteriologically and histologically
- Registration Number
- DRKS00034074
- Lead Sponsor
- Deutsches Zentrum für Infektionsforschung (DZIF)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
Arm 1: presumptive pulmonary TB (including concurrent EPTB) consulting or referred to CERMEL tuberculosis laboratory for diagnostic TB work up (including microbiological investigations (TB-culture, TB-PCR) and lung imaging)
Arm 2: healthy controls accompanying patients with presumed TB
Arm 3: TB-healthcare providers at CERME
Arm 1:
- No consent given
- No TB work-up initiated by attending physician
- Already under anti-TB treatment for >7 days
Arm 2:
- No consent given
- TB work-up initiated by attending physician
- TB diagnosed and/or under anti-TB treatment within past 6 months
- Positive WHO-symptom screen for TB disease
Arm 3:
- does not agree with recording of interview
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. non-tuberculous lung infection prevalence (mycobacterial, non-mycobacterial, fungal and parasitic) in patients with presumed TB<br>2. contribution of non-tuberculous infections to disease outcomes per confirmed” or clinical TB” or no TB diagnosed”
- Secondary Outcome Measures
Name Time Method Exploration of perspectives regarding the diagnostic process across different types of cases (clinical TB, no diagnosis made, confirmed TB) and preferences for TB diagnostic services of patients and providers