TuberculosisC3PONCT07018076
Candidate Clinical Correlate of Prognostic Outcome for TB Study
An observational study of Tuberculosis, run by University of California, San Francisco at 3 sites in 2 countries.
Trial summary
As part of the ongoing efforts within the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study, the Candidate Clinical Correlate as Prognostic Outcome for TB (C3PO) study serves as a supplement aimed at evaluating predictors and novel biomarkers of recurrent TB among TB survivors. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- RS ratio and Blood-based host immune response assays
- How many people
- 750 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Nov 2025to 31 May 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of individuals receiving programmatic treatment for drug-sensitive tuberculosis (TB) at participating outpatient TB clinics in Uganda and Vietnam. Eligible participants will be selected from among TB patients actively receiving care at these clinical sites.
Who may be able to join
- . individuals age ≥ 12 years;
- . have completed treatment for drug-susceptible tuberculosis with the standard 6-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE).
Who cannot join
- completed treatment for drug-susceptible tuberculosis >14 days prior to screening/enrollment;
- routinely taking any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason not related to tuberculosis treatment within the last 14 days;
- unwilling to provide informed consent or return for study follow-up visits.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Sophie Huddart, PhD contact
3 sites in 2 countries
Uganda2 sites, 2 recruiting
- Recruiting
Kisenyi Health Center
Kampala
William Worodria, worodria@yahoo.com
- Recruiting
Mulago Outpatient Department
Kampala
William Worodria, worodria@yahoo.com
Vietnam1 site, 1 recruiting
- Not yet recruiting
Hanoi Lung Hospital, Outpatient departments
Hanoi
Ha Phan, Ha.Phan@ucsf.edu
About this study
As part of the ongoing efforts within the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study, the Candidate Clinical Correlate as Prognostic Outcome for TB (C3PO) study serves as a supplement aimed at evaluating predictors and novel biomarkers of recurrent TB among TB survivors. Current tools for predicting TB recurrence risk are suboptimal, limiting the ability to assess new TB treatment regimens effectively. Identifying accurate sputum- or blood-based biomarkers for recurrence risk could significantly improve the efficiency and informativeness of Phase 2 and 3 clinical trials.
Read the detailed description
The Candidate Clinical Correlate as Prognostic Outcome for TB Study (C3PO) supplements the ongoing Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study by identifying and accelerating novel TB diagnostics at various stages of development and across different use cases. There is an urgent need for treatments that can cure all forms of TB more quickly. However, the development of new, shorter, and more effective antibiotic regimens is hindered by the limitations of current methods used to assess treatment effectiveness in TB drug trials. The standard pharmacodynamic (PD) marker-sputum culture-does not predict clinical outcomes well, fails to detect residual Mycobacterium tuberculosis that causes relapse, and takes 6-8 weeks to provide results. New PD markers that more accurately predict clinical outcomes would help de-risk clinical trials and ensure that only the most effective new regimens move forward. C3PO aims to evaluate non-culture PD markers in predicting recurrent TB among patients who have completed the global standard HRZE regimen for drug-susceptible pulmonary TB under routine programmatic settings.
- Conditions
- Tuberculosis
- Being tested
- RS ratio, Blood-based host immune response assays
- Keywords
- Tuberculosis, Global Health, Diagnostics
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS ratioDiagnostic test
We will evaluate the non-culture, sputum-based assay RS ratio, which measures ongoing Mycobacterium tuberculosis activity by quantifying the abundance of precursor rRNA relative to mature rRNA (an indicator of active rRNA synthesis).
Blood-based host immune response assaysDiagnostic test
We will evaluate blood-based assays measuring host immune response parameters for predicting mycobacterial activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent tuberculosis (TB)
Recurrent tuberculosis (TB), defined as a new episode of microbiologically confirmed TB occurring after completion of treatment for a prior drug-sensitive TB episode. Recurrence will be identified through routine study visits during the one year follow-up, with microbiological confirmation based on sputum mycobacterial culture.
Measured: 1 year
Prognostic accuracy of novel biomarkers in predicting recurrent TB
We will evaluate the ability of selected novel biomarkers to predict recurrent TB using the following metrics:
Area Under the Curve (AUC): Measures the overall discriminatory ability of the biomarkers to distinguish between individuals who will and will not experience recurrent TB.
Sensitivity and Specificity: Sensitivity indicates how accurately the biomarkers identify individuals who will develop recurrent TB, while specificity reflects how well they identify those who will not.
Positive Predictive Value (PPV) and Negative Predictive Value (NPV): PPV represents the proportion of individuals with a positive biomarker result who actually develop recurrent TB, while NPV reflects the proportion with a negative result who remain recurrence-free.
Kappa Statistic: Assesses the agreement between predicted outcomes based on the biomarkers and the actual observed outcomes, accounting for agreement occurring by chance.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start25 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Adithya Cattamanchi, MD, Principal investigator, University of California San Francisco; University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018076
- Sponsor's protocol ID
- U01AI152087-05S1
- Other IDs
- U01AI152087-05S1
- Acronym
- C3PO
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
STREPTOMYCIN treatment of pulmonary tuberculosis. Br Med J. 1948 Oct 30;2(4582):769-82. No abstract available.
PubMed 18890300Sharma M, Nduba V, Njagi LN, Murithi W, Mwongera Z, Hawn TR, Patel SN, Horne DJ. TBscreen: A passive cough classifier for tuberculosis screening with a controlled dataset. Sci Adv. 2024 Jan 5;10(1):eadi0282. doi: 10.1126/sciadv.adi0282. Epub 2024 Jan 3.
PubMed 38170773Phillips PPJ, Mendel CM, Nunn AJ, McHugh TD, Crook AM, Hunt R, Bateson A, Gillespie SH. A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens. BMC Med. 2017 Nov 24;15(1):207. doi: 10.1186/s12916-017-0955-9.
PubMed 29169355Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PubMed 31613151Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
PubMed 22743675Kurbatova EV, Phillips PPJ, Dorman SE, Sizemore EE, Bryant KE, Purfield AE, Ricaldi J, Brown NE, Johnson JL, Wallis CL, Akol JP, Ocheretina O, Van Hung N, Mayanja-Kizza H, Lourens M, Dawson R, Nhung NV, Pierre S, Musodza Y, Shenje J, Badal-Faesen S, Vilbrun SC, Waja Z, Peddareddy L, Scott NA, Yuan Y, Goldberg SV, Swindells S, Chaisson RE, Nahid P. A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials. Am J Respir Crit Care Med. 2023 May 15;207(10):1376-1382. doi: 10.1164/rccm.202206-1118OC.
PubMed 36790881Horne DJ, Royce SE, Gooze L, Narita M, Hopewell PC, Nahid P, Steingart KR. Sputum monitoring during tuberculosis treatment for predicting outcome: systematic review and meta-analysis. Lancet Infect Dis. 2010 Jun;10(6):387-94. doi: 10.1016/S1473-3099(10)70071-2.
PubMed 20510279Imperial MZ, Phillips PPJ, Nahid P, Savic RM. Precision-Enhancing Risk Stratification Tools for Selecting Optimal Treatment Durations in Tuberculosis Clinical Trials. Am J Respir Crit Care Med. 2021 Nov 1;204(9):1086-1096. doi: 10.1164/rccm.202101-0117OC.
PubMed 34346856Gupta-Wright A, den Boon S, MacLean EL, Cirillo D, Cobelens F, Gillespie SH, Kohli M, Ruhwald M, Savic R, Brigden G, Gidado M, Goletti D, Hanna D, Hasan R, Hewison C, Koura KG, Lienhardt C, Lungu P, McHugh TD, McKenna L, Scott C, Scriba T, Sekaggya-Wiltshire C, Kasaeva T, Zignol M, Denkinger CM, Falzon D. Target product profiles: tests for tuberculosis treatment monitoring and optimization. Bull World Health Organ. 2023 Nov 1;101(11):730-737. doi: 10.2471/BLT.23.290901. Epub 2023 Oct 4.
PubMed 37961060FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from http://www.ncbi.nlm.nih.gov/books/NBK326791/
PubMed 27010052MacLean EL, Zimmer AJ, den Boon S, Gupta-Wright A, Cirillo DM, Cobelens F, Gillespie SH, Nahid P, Phillips PP, Ruhwald M, Denkinger CM. Tuberculosis treatment monitoring tests during routine practice: study design guidance. Clin Microbiol Infect. 2024 Apr;30(4):481-488. doi: 10.1016/j.cmi.2023.12.027. Epub 2024 Jan 3.
PubMed 38182047Evangelopoulos D, Shoen CM, Honeyborne I, Clark S, Williams A, Mukamolova GV, Cynamon MH, McHugh TD. Culture-Free Enumeration of Mycobacterium tuberculosis in Mouse Tissues Using the Molecular Bacterial Load Assay for Preclinical Drug Development. Microorganisms. 2022 Feb 17;10(2):460. doi: 10.3390/microorganisms10020460.
PubMed 35208914MCCUNE RM Jr, MCDERMOTT W, TOMPSETT R. The fate of Mycobacterium tuberculosis in mouse tissues as determined by the microbial enumeration technique. II. The conversion of tuberculous infection to the latent state by the administration of pyrazinamide and a companion drug. J Exp Med. 1956 Nov 1;104(5):763-802. doi: 10.1084/jem.104.5.763.
PubMed 13367342Mukamolova GV, Turapov O, Malkin J, Woltmann G, Barer MR. Resuscitation-promoting factors reveal an occult population of tubercle Bacilli in Sputum. Am J Respir Crit Care Med. 2010 Jan 15;181(2):174-80. doi: 10.1164/rccm.200905-0661OC. Epub 2009 Oct 29.
PubMed 19875686Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med. 2021 May 6;384(18):1705-1718. doi: 10.1056/NEJMoa2033400.
PubMed 33951360
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candidate Clinical Correlate of Prognostic Outcome for TB Study
- ClinicalTrials.gov ID
- NCT07018076
- Acronym / sponsor ID
- C3PO / U01AI152087-05S1
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Global Health, Diagnostics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Jun 2025 (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.
As part of the ongoing efforts within the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study, the Candidate Clinical Correlate as Prognostic Outcome for TB (C3PO) study serves as a supplement aimed at evaluating predictors and novel biomarkers of recurrent TB among TB survivors. Current tools for predicting TB recurrence risk are suboptimal, limiting the ability to assess new TB treatment regimens effectively. Identifying accurate sputum- or blood-based biomarkers for recurrence risk could significantly improve the efficiency and informativeness of Phase 2 and 3 clinical trials.
Detailed description
The Candidate Clinical Correlate as Prognostic Outcome for TB Study (C3PO) supplements the ongoing Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study by identifying and accelerating novel TB diagnostics at various stages of development and across different use cases. There is an urgent need for treatments that can cure all forms of TB more quickly. However, the development of new, shorter, and more effective antibiotic regimens is hindered by the limitations of current methods used to assess treatment effectiveness in TB drug trials. The standard pharmacodynamic (PD) marker-sputum culture-does not predict clinical outcomes well, fails to detect residual Mycobacterium tuberculosis that causes relapse, and takes 6-8 weeks to provide results. New PD markers that more accurately predict clinical outcomes would help de-risk clinical trials and ensure that only the most effective new regimens move forward. C3PO aims to evaluate non-culture PD markers in predicting recurrent TB among patients who have completed the global standard HRZE regimen for drug-susceptible pulmonary TB under routine programmatic settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of individuals receiving programmatic treatment for drug-sensitive tuberculosis (TB) at participating outpatient TB clinics in Uganda and Vietnam. Eligible participants will be selected from among TB patients actively receiving care at these clinical sites.
Key inclusion criteria (2 listed)
- . individuals age ≥ 12 years;
- . have completed treatment for drug-susceptible tuberculosis with the standard 6-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE).
Key exclusion criteria (3 listed)
- completed treatment for drug-susceptible tuberculosis >14 days prior to screening/enrollment;
- routinely taking any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason not related to tuberculosis treatment within the last 14 days;
- unwilling to provide informed consent or return for study follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RS ratioWe will evaluate the non-culture, sputum-based assay RS ratio, which measures ongoing Mycobacterium tuberculosis activity by quantifying the abundance of precursor rRNA relative to mature rRNA (an indicator of active rRNA synthesis). | Diagnostic test | – |
| Blood-based host immune response assaysWe will evaluate blood-based assays measuring host immune response parameters for predicting mycobacterial activity. | Diagnostic test | – |
Primary outcome
Recurrent tuberculosis (TB)
Time frame: 1 year
Recurrent tuberculosis (TB), defined as a new episode of microbiologically confirmed TB occurring after completion of treatment for a prior drug-sensitive TB episode. Recurrence will be identified through routine study visits during the one year follow-up, with microbiological confirmation based on sputum mycobacterial culture.
Prognostic accuracy of novel biomarkers in predicting recurrent TB
Time frame: 1 year
We will evaluate the ability of selected novel biomarkers to predict recurrent TB using the following metrics: Area Under the Curve (AUC): Measures the overall discriminatory ability of the biomarkers to distinguish between individuals who will and will not experience recurrent TB. Sensitivity and Specificity: Sensitivity indicates how accurately the biomarkers identify individuals who will develop recurrent TB, while specificity reflects how well they identify those who will not. Positive Predictive Value (PPV) and Negative Predictive Value (NPV): PPV represents the proportion of individuals with a positive biomarker result who actually develop recurrent TB, while NPV reflects the proportion with a negative result who remain recurrence-free. Kappa Statistic: Assesses the agreement between predicted outcomes based on the biomarkers and the actual observed outcomes, accounting for agreement occurring by chance.
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 20 Jul 2026.
- Background: PubMed 18890300STREPTOMYCIN treatment of pulmonary tuberculosis. Br Med J. 1948 Oct 30;2(4582):769-82. No abstract available.
- Background: PubMed 38170773Sharma M, Nduba V, Njagi LN, Murithi W, Mwongera Z, Hawn TR, Patel SN, Horne DJ. TBscreen: A passive cough classifier for tuberculosis screening with a controlled dataset. Sci Adv. 2024 Jan 5;10(1):eadi0282. doi: 10.1126/sciadv.adi0282. Epub 2024 Jan 3.
- Background: PubMed 29169355Phillips PPJ, Mendel CM, Nunn AJ, McHugh TD, Crook AM, Hunt R, Bateson A, Gillespie SH. A comparison of liquid and solid culture for determining relapse and durable cure in phase III TB trials for new regimens. BMC Med. 2017 Nov 24;15(1):207. doi: 10.1186/s12916-017-0955-9.
- Background: PubMed 31613151Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
- Background: PubMed 22743675Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Background: PubMed 36790881Kurbatova EV, Phillips PPJ, Dorman SE, Sizemore EE, Bryant KE, Purfield AE, Ricaldi J, Brown NE, Johnson JL, Wallis CL, Akol JP, Ocheretina O, Van Hung N, Mayanja-Kizza H, Lourens M, Dawson R, Nhung NV, Pierre S, Musodza Y, Shenje J, Badal-Faesen S, Vilbrun SC, Waja Z, Peddareddy L, Scott NA, Yuan Y, Goldberg SV, Swindells S, Chaisson RE, Nahid P. A Standardized Approach for Collection of Objective Data to Support Outcome Determination for Late-Phase Tuberculosis Clinical Trials. Am J Respir Crit Care Med. 2023 May 15;207(10):1376-1382. doi: 10.1164/rccm.202206-1118OC.
- Background: PubMed 20510279Horne DJ, Royce SE, Gooze L, Narita M, Hopewell PC, Nahid P, Steingart KR. Sputum monitoring during tuberculosis treatment for predicting outcome: systematic review and meta-analysis. Lancet Infect Dis. 2010 Jun;10(6):387-94. doi: 10.1016/S1473-3099(10)70071-2.
- Background: PubMed 34346856Imperial MZ, Phillips PPJ, Nahid P, Savic RM. Precision-Enhancing Risk Stratification Tools for Selecting Optimal Treatment Durations in Tuberculosis Clinical Trials. Am J Respir Crit Care Med. 2021 Nov 1;204(9):1086-1096. doi: 10.1164/rccm.202101-0117OC.
- Background: PubMed 37961060Gupta-Wright A, den Boon S, MacLean EL, Cirillo D, Cobelens F, Gillespie SH, Kohli M, Ruhwald M, Savic R, Brigden G, Gidado M, Goletti D, Hanna D, Hasan R, Hewison C, Koura KG, Lienhardt C, Lungu P, McHugh TD, McKenna L, Scott C, Scriba T, Sekaggya-Wiltshire C, Kasaeva T, Zignol M, Denkinger CM, Falzon D. Target product profiles: tests for tuberculosis treatment monitoring and optimization. Bull World Health Organ. 2023 Nov 1;101(11):730-737. doi: 10.2471/BLT.23.290901. Epub 2023 Oct 4.
- Background: PubMed 27010052FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet]. Silver Spring (MD): Food and Drug Administration (US); 2016-. Available from http://www.ncbi.nlm.nih.gov/books/NBK326791/
- Background: PubMed 38182047MacLean EL, Zimmer AJ, den Boon S, Gupta-Wright A, Cirillo DM, Cobelens F, Gillespie SH, Nahid P, Phillips PP, Ruhwald M, Denkinger CM. Tuberculosis treatment monitoring tests during routine practice: study design guidance. Clin Microbiol Infect. 2024 Apr;30(4):481-488. doi: 10.1016/j.cmi.2023.12.027. Epub 2024 Jan 3.
- Background: PubMed 35208914Evangelopoulos D, Shoen CM, Honeyborne I, Clark S, Williams A, Mukamolova GV, Cynamon MH, McHugh TD. Culture-Free Enumeration of Mycobacterium tuberculosis in Mouse Tissues Using the Molecular Bacterial Load Assay for Preclinical Drug Development. Microorganisms. 2022 Feb 17;10(2):460. doi: 10.3390/microorganisms10020460.
- Individual participant dataSharing planned: No
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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.
Sophie Huddart, PhD contact
Adithya Cattamanchi, MD principal investigator
University of California San Francisco; University of California Irvine
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by University of California, San Francisco at 3 sites in 2 countries.
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 2 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Uganda, Vietnam. 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?
Contact Adithya Cattamanchi, MD (415-206-5489, adithya.cattamanchi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent tuberculosis (TB) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07018076, which also lists 23 linked publications.
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 20 Jul 2026.