Status:
UNKNOWN
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
Lead Sponsor:
The Aurum Institute NPC
Collaborating Sponsors:
Ludwig-Maximilians - University of Munich
Research Center Borstel
Conditions:
Respiratory Tract Infections
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
Brief Summary
This is an observational cohort study. Pulmonary tuberculosis (TB) patients will be enrolled at the time of TB diagnosis and prospectively followed for at least two years after TB-treatment initiation...
Detailed Description
The African continent today is emblematic of TB as a global health emergency with little known about the long-term sequelae. It is likely that TB patients from resource-constrained settings, who usual...
Eligibility Criteria
Inclusion
- At least one sputum sample tested positive for Mtb by Xpert MTB/RIF assay in the study clinic/study laboratory or at least one sputum sample tested positive by culture methods in study laboratory or other TB laboratory
- Be ≥ 18 years of age
- Willingness to provide a written consent or witnessed oral consent in the case of illiteracy for participation in the study, prior to patient's first sample or other study-specific data being collected
- Willing to be tested for HIV infection
- Agrees to the collection and storage of blood, urine, and sputum specimens for use in future research
- Willing to start anti-TB treatment after TB diagnosis
- Living within the study area and willing to inform the study team of any change of address during the treatment and follow-up period
Exclusion
- Has received TB treatment in the last 6 months
- Has incapacity to produce and provide two sputum samples of sufficient quality (3 ml)
- Has severe medical or psychiatric condition which in the opinion of the site investigator or designee, might interfere with the ability to give true informed consent and to adhere to the study requirements
- Is currently imprisoned
- Taking part in investigational product trials related to TB and/or lung diseases
Key Trial Info
Start Date :
September 22 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03251196
Start Date
September 22 2017
End Date
June 30 2022
Last Update
January 13 2021
Active Locations (4)
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1
Instituto Nacional de Saúde
Maputo, Mozambique
2
The Clinical HIV Research Unit
Johannesburg, Gauteng, South Africa, 2092
3
NIMR-Mbeya Medical Research Centre
Mbeya, Tanzania
4
The MRC-Unit
Fajara, The Gambia