Compliance, PatientPhase 4DOT-LTBINCT03266991
Treatment of Latent Tuberculosis in Socially Marginalised Citizens
A Phase 4 study testing Rifapentine and Isoniazid in people with Compliance, Patient, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compliance, Patient
- What is being tested?
- Rifapentine and Isoniazid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesDenmark
- Study dates
- 27 Oct 2017to 9 Feb 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs
- LTBI defined by positive IGRA test
- Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years
- Aged 18 years or older
Who cannot join
- Previously treated for tuberculosis
- Pregnant or breastfeeding
- Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)
- Unable to give informed consent
- Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB
- Known HIV on antiretroviral treatment
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- Porphyria
- Known allergy to rifamycins or isoniazid
- Known epilepsy
- Known liver disease causing affected liver parameters (ALAT, alkaline phosphatase, bilirubin, INR)
- Any lab abnormality, disease, concomitant medication or condition that, in the opinion of the investigator, excludes a person from participating
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept of Pulmonary Medicine
Aarhus, 8000
Dept of Pulmonary Medicine
Esbjerg, 6700
About this study
Official title: A Randomised Controlled Trial of a 12-dose Rifapentine and Isoniazid (RPT+INH) Regimen Using Direct Observed Therapy (DOT) Versus 6 Months of Daily Isoniazid for Latent Tuberculosis Infection (LTBI) in Socially Marginalised People
An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.
Read the detailed description
Eligible participants will be randomised to receive either daily isoniazid for 6 months with monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct observed therapy where the drugs are administered in the presence of a study nurse or doctor.
Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes and leukocyte differential count) will be taken at baseline and at least once during treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only group.
One year after treatment completion participants will be called in for evaluation for active tuberculosis.
- Conditions
- Compliance, Patient
- Being tested
- Rifapentine, Isoniazid
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifapentineDrug
Also called isoniazid
Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
IsoniazidDrug
Treatment with daily isoniazid in 6 months
| Study group | Role | What they receive |
|---|---|---|
| RPT-INH | Experimental | Participants treated with weekly rifapentine and isoniazid for twelve weeks. Receives: Drug: Rifapentine; Drug: Isoniazid |
| control | Active comparator | Participants treated with daily isoniazid for six months Receives: Drug: Isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence
adherence to treatment in the two groups measured by counting number of pills taken in each group.
Measured: 2 years
Secondary outcomes (2)
active tuberculosis
active tuberculosis within the study period. In case of suspected tuberculosis during the study the participant will be refered for examination by specialists. At 1 year follow-up participants will have a chest x-ray and physical examination by study doctor to screen for signs of active tuberculosis. If active tuberculosis is suspected further examinations will be performed by specialists.
Measured: 5 years
adverse events
for both groups all adverse events will be recorded
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start27 Oct 2017
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, PatientStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Breinholt Stærke, Aarhus University Hospital
- Investigators
- Christian Wejse, MD PHD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266991
- Sponsor's protocol ID
- A101A
- Acronym
- DOT-LTBI
- Status last verified
- Jul 2021
- First submitted
- 11 Aug 2017
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of a 12-dose Rifapentine and Isoniazid (RPT+INH) Regimen Using Direct Observed Therapy (DOT) Versus 6 Months of Daily Isoniazid for Latent Tuberculosis Infection (LTBI) in Socially Marginalised People
- ClinicalTrials.gov ID
- NCT03266991
- Acronym / sponsor ID
- DOT-LTBI / A101A
- Conditions
- Compliance, Patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 30 Aug 2017 (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.
An open-label, randomised controlled trial comparing compliance to treatment for latent tuberculosis infection in socially marginalised citizens. Participants will be randomized to either daily isoniazid for 6 months or weekly rifapentine and isoniazid as directly observed therapy for twelve weeks.
Detailed description
Eligible participants will be randomised to receive either daily isoniazid for 6 months with monthly visits for pill count, evaluation of adverse events and dispensing of isoniazid for the next month, or weekly doses of rifapentine and isoniazid for twelve weeks as direct observed therapy where the drugs are administered in the presence of a study nurse or doctor.
Control bloodsamples (ALAT, alkaline phosphatase, bilirubin, INR, haemoglobin, trombocytes and leukocyte differential count) will be taken at baseline and at least once during treatment in the rifapentine and isoniazid group and at least twice in the isoniazid-only group.
One year after treatment completion participants will be called in for evaluation for active tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPT-INH | Experimental | Drug: Rifapentine, Drug: IsoniazidParticipants treated with weekly rifapentine and isoniazid for twelve weeks. |
| control | Active comparator | Drug: IsoniazidParticipants treated with daily isoniazid for six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reporting to be homeless (independent of whether the person has an official address) or regularly seeking homeless shelters or public institutions to supply basic needs
- LTBI defined by positive IGRA test
- Found plausible by study doctor that the person has been exposed to tuberculosis within 2 years
- Aged 18 years or older
Key exclusion criteria (11 listed)
- Previously treated for tuberculosis
- Pregnant or breastfeeding
- Active tuberculosis (evaluated by chest x-ray and examination by a trained doctor)
- Unable to give informed consent
- Tested positive for LTBI as part of contact investigation where the index case has or is suspected to have INH of RIF resistant TB
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 |
|---|---|---|
| RifapentineAlso: isoniazidTreatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks | Drug | RPT-INH |
| IsoniazidTreatment with daily isoniazid in 6 months | Drug | RPT-INH, control |
Primary outcome
adherence
Time frame: 2 years
adherence to treatment in the two groups measured by counting number of pills taken in each group.
2 secondary outcomes
active tuberculosis
Time frame: 5 years
adverse events
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- 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. This study is not recruiting at the moment.
Christian Wejse, MD PHD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifapentine and Isoniazid in people with Compliance, Patient, run by Aarhus University Hospital at 2 sites in Denmark.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
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?
adherence (time frame: 2 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 12 Oct 2023.