TuberculosisNCT03639038
Tuberculosis Diagnosis by Flow Cytometry
An observational study of Tuberculosis, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Read more about this study
- Who is it for?
- Ages 5 to 100 years
- Conditions the study is for
- Tuberculosis
- How many people
- 0 participants
- Where
- 1 siteZambia
- Study dates
- 30 Sep 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 100 years
- All sexes
- Child, Adult, Older adult
Study population: Participants will be selected on a first come, first serve basis at TB clinics in MOH District clinics in Lusaka. The participants will include both confirmed TB patients as well as presumptive TB patients. All participants should not have started anti-TB treatment (ATT) prior to enrollment or be less than five days from treatment start.
Who may be able to join
- Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
- Patients with multi-drug resistant TB (MDR-TB)
- Paediatric patients (< 15 years old)
- Patients suspected of extra-pulmonary tuberculosis
- Patients with TB/HIV co-infection
Who cannot join
- Unable/unwilling to sign Informed consent
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Center for Infectious Disease Research in Zambia (CIDRZ)
Lusaka, 10102
About this study
Official title: Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.
Read the detailed description
Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:
- Activated TB assay for differentiation of latent and active TB infection using blood samples and
- Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)
- Conditions
- Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood Assay Phase - 1 | TB Positive / HIV Positive: 65 participants | |
| Blood Assay Phase - 2 | TB positive / HIV Negative: 65 participants | |
| Blood Assay Phase - 3 | TB positive and negative Paediatric: 30 participants | |
| Blood Assay Phase - 4 | TB Negative/HIV positive: 50 participants | |
| Blood Assay Phase - 5 | Healthy controls: 30 participants | |
| Sputum Collection Phase - 1 | TB Positive: Xpert Rif sensitive: 100 participants | |
| Sputum Collection Phase - 2 | TB Positive: Xpert Rif resistant: 20 | |
| Sputum Collection Phase - 3 | TB Negative: Other chest: unknown number | |
| Sputum Collection Phase - 4 | TB Negative: Smear negative/Xpert negative: 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ATB assay for differentiation of latent and active TB infection using Blood samples
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
Measured: The duration of this project is 9 months.
DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
Measured: The duration of this project is 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start30 Sep 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Why it stopped: PI retired, study never opened.
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.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stewart Reid, University of Alabama at Birmingham
- Investigators
- Monde Muyoyeta, MD, PhD, Principal investigator, Center for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639038
- Sponsor's protocol ID
- IRB-300001699
- Status last verified
- Nov 2018
- First submitted
- 14 Aug 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reagent Evaluation Plan: Tuberculosis Diagnosis by Flow Cytometry (Project Orion)
- ClinicalTrials.gov ID
- NCT03639038
- Acronym / sponsor ID
- IRB-300001699
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI retired, study never opened.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 20 Aug 2018 (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.
Tuberculosis and HIV continue to be major public health problems in resource constrained settings like Zambia. Zambia is among the top 30 highest burden countries globally. The major drivers of TB in the Africa region is the HIV epidemic. Inadequate TB diagnostic tools with failure to make a timely diagnosis and start appropriate treatment are the major impediments to TB control in Zambia and globally.
Detailed description
Project Orion is focused on utilizing Flow Cytometry Technology to screen and diagnose tuberculosis. There are two assays being tested under this Project:
- Activated TB assay for differentiation of latent and active TB infection using blood samples and
- Direct TB assay (DTA) for rapid detection and DST of Mycobacterium tuberculosis (Mtb) using sputum specimens.)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Blood Assay Phase - 1 | – | –TB Positive / HIV Positive: 65 participants |
| Blood Assay Phase - 2 | – | –TB positive / HIV Negative: 65 participants |
| Blood Assay Phase - 3 | – | –TB positive and negative Paediatric: 30 participants |
| Blood Assay Phase - 4 | – | –TB Negative/HIV positive: 50 participants |
| Blood Assay Phase - 5 | – | –Healthy controls: 30 participants |
| Sputum Collection Phase - 1 | – | –TB Positive: Xpert Rif sensitive: 100 participants |
| Sputum Collection Phase - 2 | – | –TB Positive: Xpert Rif resistant: 20 |
| Sputum Collection Phase - 3 | – | –TB Negative: Other chest: unknown number |
| Sputum Collection Phase - 4 | – | –TB Negative: Smear negative/Xpert negative: 20 |
Who may qualify
- Ages
- 5 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be selected on a first come, first serve basis at TB clinics in MOH District clinics in Lusaka. The participants will include both confirmed TB patients as well as presumptive TB patients. All participants should not have started anti-TB treatment (ATT) prior to enrollment or be less than five days from treatment start.
Key inclusion criteria (5 listed)
- Presumptive TB patients (patients recommended for tuberculosis diagnostic testing and not on ATT)
- Patients with multi-drug resistant TB (MDR-TB)
- Paediatric patients (< 15 years old)
- Patients suspected of extra-pulmonary tuberculosis
- Patients with TB/HIV co-infection
Key exclusion criteria (1 listed)
- Unable/unwilling to sign 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
ATB assay for differentiation of latent and active TB infection using Blood samples
Time frame: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
DTB assay for rapid detection and drug sensitivity testing of Mtb using sputum specimens
Time frame: The duration of this project is 9 months.
To evaluate the clinical utility of the test reagent(s) compared to diagnostic gold Standard: Culture and Xpert MTB/Rif along with clinical (empiric) diagnosis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Tuberculosis (TB)
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
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.
Monde Muyoyeta, MD, PhD principal investigator
Center for Infectious Disease Research in Zambia
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 University of Alabama at Birmingham 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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Nov 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ATB assay for differentiation of latent and active TB infection using Blood samples (time frame: The duration of this project is 9 months.). 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?
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 Nov 2018.