TuberculosisIeDea TB-SRNNCT07798167
Tuberculosis Sentinel Research Network (TB-SRN)
An observational study of Tuberculosis, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
The overarching objective/aim of the study is to assess pulmonary TB treatment and longer-term outcomes among people with and without HIV in African population in order to inform policy and practice around TB treatment and create a platform for additional TB research in Zambia Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Tuberculosis
- How many people
- 374 participants
- Where
- 1 siteZambia
- Study dates
- 15 Sep 2022to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 553
Who may be able to join
- 1. Be ≥15 years of age
- Clinically diagnosed pulmonary TB and initiated/to be initiated on anti-TB treatment, as determined by medical providers through standard of care, on the basis of either.
- Microbiologically confirmed pulmonary TB based on sputum or other respiratory samples with either
Who cannot join
- Have plans to follow-up for TB care at a site distant from the enrollment site, imminent plans to move from his/her current area of residence, or plans to return to a distant area of residence, which would interfere with the participant's ability to complete all study visits (through the 12-month post-treatment visit).
- 1. Received >1 week of TB treatment within the prior 30 days, excluding TB preventive therapy
- 3. Have substantial cognitive impairment that in the opinion of the site investigator or designee may interfere with the ability to give reliable informed consent
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Chawama and Kanyama General Hospitals
Lusaka, Lusaka Province, 10101
About this study
The overarching objective/aim of the study is to assess pulmonary TB treatment and longer-term outcomes among people with and without HIV in African population in order to inform policy and practice around TB treatment and create a platform for additional TB research in Zambia
Read the detailed description
The TB-SRN study will be a prospective observational non-interventional study open to enrollment for individuals ≥15 years of age diagnosed with active pulmonary TB that is either bacteriologically confirmed or clinically diagnosed in HIV-positive and HIV-negative participants. The enrollment will be consecutively, regardless of drug resistance and HIV status. When the sample size of 300 consecutively enrolled TB patients is reached per site, we will enroll additionally drug-resistant TB patients (defined as GeneXpert MTB/RIF positive) until will reach a target of 150 drug resistant TB patients at each site. TB treatment will be managed according to and by the existing standard of care/systems, but those who provide informed consent and agree to participate will contribute other study-related data, which may require additional radiograph(s), laboratory tests, and healthcare-related outcomes measures beyond those collected during routine care. Participants may be co-enrolled in an affiliated or external observational or interventional study
- Conditions
- Tuberculosis
- Keywords
- TB-Transmission
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment
The proportion of participants who achieve a successful pulmonary tuberculosis treatment outcome at the end of the TB treatment period. Treatment success will be defined according to the study-prespecified TB treatment outcome definitions and will be compared between participants with and without HIV.
Measured: 4 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Sep 2022
- Primary completion22 Dec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798167
- Sponsor's protocol ID
- IeDea TB-SRN 2538-2022
- Acronym
- IeDea TB-SRN
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Sentinel Research Network (TB-SRN)
- ClinicalTrials.gov ID
- NCT07798167
- Acronym / sponsor ID
- IeDea TB-SRN / IeDea TB-SRN 2538-2022
- Conditions
- Tuberculosis
- Keywords
- TB-Transmission
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching objective/aim of the study is to assess pulmonary TB treatment and longer-term outcomes among people with and without HIV in African population in order to inform policy and practice around TB treatment and create a platform for additional TB research in Zambia
Detailed description
The TB-SRN study will be a prospective observational non-interventional study open to enrollment for individuals ≥15 years of age diagnosed with active pulmonary TB that is either bacteriologically confirmed or clinically diagnosed in HIV-positive and HIV-negative participants. The enrollment will be consecutively, regardless of drug resistance and HIV status. When the sample size of 300 consecutively enrolled TB patients is reached per site, we will enroll additionally drug-resistant TB patients (defined as GeneXpert MTB/RIF positive) until will reach a target of 150 drug resistant TB patients at each site. TB treatment will be managed according to and by the existing standard of care/systems, but those who provide informed consent and agree to participate will contribute other study-related data, which may require additional radiograph(s), laboratory tests, and healthcare-related outcomes measures beyond those collected during routine care. Participants may be co-enrolled in an affiliated or external observational or interventional study
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 553
Key inclusion criteria (3 listed)
- 1. Be ≥15 years of age
- Clinically diagnosed pulmonary TB and initiated/to be initiated on anti-TB treatment, as determined by medical providers through standard of care, on the basis of either.
- Microbiologically confirmed pulmonary TB based on sputum or other respiratory samples with either
Key exclusion criteria (3 listed)
- Have plans to follow-up for TB care at a site distant from the enrollment site, imminent plans to move from his/her current area of residence, or plans to return to a distant area of residence, which would interfere with the participant's ability to complete all study visits (through the 12-month post-treatment visit).
- 1. Received >1 week of TB treatment within the prior 30 days, excluding TB preventive therapy
- 3. Have substantial cognitive impairment that in the opinion of the site investigator or designee may interfere with the ability to give reliable informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment
Time frame: 4 YEARS
The proportion of participants who achieve a successful pulmonary tuberculosis treatment outcome at the end of the TB treatment period. Treatment success will be defined according to the study-prespecified TB treatment outcome definitions and will be compared between participants with and without HIV.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment (time frame: 4 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.