Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03251196 |
| Other study ID # |
LMU-IMPH-TB Sequel-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 22, 2017 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
The Aurum Institute NPC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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 with optional prolonged follow-up. Study visits will be performed in
the study clinics or if necessary at the participant's home at pre-defined time points after
TB treatment initiation. Clinical assessments, biological sample collections and collection
of socio-economic data will be performed according to the pre-defined schedule of events.
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 usually present with more extensive disease, are left with greater lung
impairment.
This project aims to advance the understanding of the clinical, microbiologic, and host
immune factors affecting the long-term sequelae of pulmonary tuberculosis; to identify the
most important factors that contribute to lung impairment, including the immunological
response and genetic predisposition of the host and differences in the biology of the
pathogen; to determine occurrence of reversible and irreversible costs and socioeconomic
consequences for patients; and to facilitate novel interventions to restore and preserve
overall health, well-being and financial protection in patients with TB.
The core of the current project is a prospective cohort of up to 1600 patients across four
countries (Mozambique, Tanzania, South Africa and The Gambia), enrolled at the time of TB
diagnosis, and followed up for at least 2 years. The overall goal of the cohort is to
describe and analyse the basis of the long-term clinical consequences of pulmonary TB, with a
particular focus on lung injury. The investigators will enroll patients during two years and
follow each patient up for at least two years. The project also includes a number of
sub-studies: Host-Immunology, Pathogen and Socio-Economic. General laboratory tests and TB
specific tests, X-ray, physical examination and cardio-pulmonary assessment will be performed
and the obtained clinical data will be recorded in study questionnaires. The investigators
will collect and analyse biological specimens (blood, urine and sputum) longitudinally during
the period of observation and after all specimens have been stored. In-depth analysis of the
host immune response, focusing on potential mechanisms of lung damage, including oxidative
injury, proteolytic matrix degradation, and neutrophil-mediated damage, neutrophil-macrophage
ratios and markers; and molecular analysis of mycobacterial dynamics and markers in relation
to pulmonary and microbiological treatment outcomes, including success, failure, relapse,
reinfection and death will be carried out. Socio-economic data, including patient costs, will
be collected at the time of TB diagnosis, during treatment, at the end of treatment and
during the follow-up period, and analysed to determine how the risk of TB sequelae is linked
with the socioeconomic position of the patient, to establish the occurrence of catastrophic
costs due to TB and the proportion of patients that resort to potentially irreversible
socioeconomic coping strategies.
Accurate data source will be maintained and confidentiality will be guaranteed. Data will be
analysed according to the statistical plan. Results of the study will be disseminated to all
relevant stakeholders through meetings, reports and publications.
