Latent TuberculosisCATAPULTNCT03069807
Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis
A study testing Community/Primary Care and Hospital/TB Clinic in people with Latent Tuberculosis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Community/Primary Care and Hospital/TB Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Mar 2020
- Phase
- Interventional
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with LTBI aged 16-35 and who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,000.
- Latent Tuberculosis is defined as a positive IGRA test without any symptoms or physical signs of active Tuberculosis and no evidence of active Tuberculosis on Chest X-ray.
Who cannot join
- Pregnant or breastfeeding women
- Patients requiring medications that cannot be safely taken with Rifinah
- HIV infection.
- Individuals with known liver disease, or abnormal liver function tests (LFTs)
- Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
- Chronic or active hepatitis B or hepatitis C virus infection
Show all 9Show fewer
- Previous treatment for TB or LTBI.
- Individuals who are unable to consent or who would usually be offered LTBI treatment under DOT because of their mental or social disabilities or those with drug or alcohol abuse
- Evidence of active TB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.
This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic.
Read the detailed description
People with dormant/latent TB (LTBI) have TB bacteria in their bodies, but do not have any symptoms because the bacteria are not active. The investigators know that recent migrants with LTBI from countries where TB is very common (incidence greater than 150 per 100 000) are at risk of developing active TB (their dormant bacteria become active) after they arrive in the UK. Active TB can be both infectious and deadly. The treatment for LTBI is three-month course of antibiotics. This significantly reduces the risk of developing active TB. This treatment is currently arranged and supervised by hospital clinics, however, many migrants do not attend and numbers of people completing antibiotics is low. This leaves many at risk of developing active TB. This study investigates whether a community (primary care) based approach to the treatment of LTBI, coordinated by general practices and local pharmacists, will achieve higher rates of antibiotic completion. The London Borough of Newham, in the UK, has amongst the highest rates of active TB in Western Europe. As part of a strategy to tackle this disease burden, an innovative model of care has been implemented in the borough in which GPs and pharmacists screen and treat migrants with LTBI. Our trial will evaluate whether primary care based management of LTBI leads to higher rates of treatment completion amongst recent migrants when compared to hospital based care. This approach would save money (both for the health service and for patients in terms of travels costs) and reduce numbers of new cases of active TB.
The treatment for Latent Tuberculosis Infection will be 3 months of combined oral Rifampicin and Isoniazid with Pyridoxine. The dosage is weight dependent.
- Conditions
- Latent Tuberculosis
- Being tested
- Community/Primary Care, Hospital/TB Clinic
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community/Primary CareOther
The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists
Hospital/TB ClinicOther
The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants with LTBI will be treated in the Community/Primary Care. Receives: Other: Community/Primary Care |
| Control | Active comparator | Participants with LTBI will be treated in the Hospital/TB Clinic Receives: Other: Hospital/TB Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Latent Tuberculosis Treatment
Based on patients taking at least 90 percent of doses of Rifinah during 3 months of treatment.
Measured: 3 months
Secondary outcomes (8)
Complete of Latent Tuberculosis Treatment
Based on patients taking at least 80 or 85 percent of doses during 3 months of treatment.
Measured: 3 months
Adherence to Treatment
To describe the proportion of individuals in the two treatment arms who adhere to LTBI treatment based on the five-point MARS5 (Medication Adherence Report Scale) questionairre, collection of prescriptions and a point of care urine testing for metabolites of isoniazid (Iso-screen) performed at monthly intervals.
Measured: 3 months
Acceptability of Treatment
To describe the proportion of individuals in the two treatment arms who accept LTBI treatment. This is defined as those initiating treatment and attending TB clinics and community pharmacies on at least one occasion.
Measured: 3 months
Adverse Effects of Treatment
To assess the incidence of adverse effects of treatment for LTBI, including adverse liver function tests or any other effects leading to cessation of treatment. This will be assessed using liver function test results, and a monthly questionnaire.
Measured: 3 months
Active Tuberculosis
The incidence of active TB occurring within 2 years after enrolment. TB incidence in the intervention and control group will be compared and there will be a sub-analysis of examining those who did or did not accept or complete treatment. This will be performed through matching the study population with the national Enhanced TB Surveillance System, where information on all reported TB cases nationally are recorded.
Measured: 2 years
Patient Satisfaction
Assessed using a standardised non-validated questionnaire (Likert scale)
Measured: 3 months
Cost-effectiveness of Treatment
Assessed using a health economic model that includes locally and nationally agreed tariffs for latent tuberculosis treatment.
Measured: 2 years
Patient Knowledge
The impact of patients knowledge about Latent Tuberculosis on treatment acceptance and completion will be assessed at baseline using a standardised non-validated questionnaire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startJan 2017
- Primary completionSep 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomised trial evaluating treatment completion (the primary outcome), uptake, acceptability, safety and cost-effectiveness of treating latent tuberculosis infection (LTBI) in migrants in primary care, compared with secondary care.
- Masking
- None (open label)
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Public Health England
- Responsible party
- Sponsor
- Investigators
- Heinke Kunst, MD MSc, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069807
- Sponsor's protocol ID
- 4212301
- Acronym
- CATAPULT
- Status last verified
- Jan 2018
- First submitted
- 5 Aug 2016
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burman M, Zenner D, Copas AJ, Gosce L, Haghparast-Bidgoli H, White PJ, Hickson V, Greyson O, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths CJ, Kunst H. Treatment of latent tuberculosis infection in migrants in primary care versus secondary care. Eur Respir J. 2024 Nov 7;64(5):2301733. doi: 10.1183/13993003.01733-2023. Print 2024 Nov.
PubMed 39174285Burman M, Copas A, Zenner D, Hickson V, Gosce L, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths C, Kunst H. Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: the CATAPuLT trial. BMC Public Health. 2019 Nov 29;19(1):1598. doi: 10.1186/s12889-019-7983-7.
PubMed 31783742
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03069807
- Acronym / sponsor ID
- CATAPULT / 4212301
- Conditions
- Latent Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University College, London, Public Health England
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 3 Mar 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.
This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic.
Detailed description
People with dormant/latent TB (LTBI) have TB bacteria in their bodies, but do not have any symptoms because the bacteria are not active. The investigators know that recent migrants with LTBI from countries where TB is very common (incidence greater than 150 per 100 000) are at risk of developing active TB (their dormant bacteria become active) after they arrive in the UK. Active TB can be both infectious and deadly. The treatment for LTBI is three-month course of antibiotics. This significantly reduces the risk of developing active TB. This treatment is currently arranged and supervised by hospital clinics, however, many migrants do not attend and numbers of people completing antibiotics is low. This leaves many at risk of developing active TB. This study investigates whether a community (primary care) based approach to the treatment of LTBI, coordinated by general practices and local pharmacists, will achieve higher rates of antibiotic completion. The London Borough of Newham, in the UK, has amongst the highest rates of active TB in Western Europe. As part of a strategy to tackle this disease burden, an innovative model of care has been implemented in the borough in which GPs and pharmacists screen and treat migrants with LTBI. Our trial will evaluate whether primary care based management of LTBI leads to higher rates of treatment completion amongst recent migrants when compared to hospital based care. This approach would save money (both for the health service and for patients in terms of travels costs) and reduce numbers of new cases of active TB.
The treatment for Latent Tuberculosis Infection will be 3 months of combined oral Rifampicin and Isoniazid with Pyridoxine. The dosage is weight dependent.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomised trial evaluating treatment completion (the primary outcome), uptake, acceptability, safety and cost-effectiveness of treating latent tuberculosis infection (LTBI) in migrants in primary care, compared with secondary care.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Community/Primary CareParticipants with LTBI will be treated in the Community/Primary Care. |
| Control | Active comparator | Other: Hospital/TB ClinicParticipants with LTBI will be treated in the Hospital/TB Clinic |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with LTBI aged 16-35 and who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,000.
- Latent Tuberculosis is defined as a positive IGRA test without any symptoms or physical signs of active Tuberculosis and no evidence of active Tuberculosis on Chest X-ray.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- Patients requiring medications that cannot be safely taken with Rifinah
- HIV infection.
- Individuals with known liver disease, or abnormal liver function tests (LFTs)
- Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
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 |
|---|---|---|
| Community/Primary CareThe treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists | Other | Intervention |
| Hospital/TB ClinicThe treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses | Other | Control |
Primary outcome
Completion of Latent Tuberculosis Treatment
Time frame: 3 months
Based on patients taking at least 90 percent of doses of Rifinah during 3 months of treatment.
8 secondary outcomes
Complete of Latent Tuberculosis Treatment
Time frame: 3 months
Adherence to Treatment
Time frame: 3 months
Acceptability of Treatment
Time frame: 3 months
Adverse Effects of Treatment
Time frame: 3 months
Active Tuberculosis
Time frame: 2 years
Patient Satisfaction
Time frame: 3 months
Cost-effectiveness of Treatment
Time frame: 2 years
Patient Knowledge
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 39174285Burman M, Zenner D, Copas AJ, Gosce L, Haghparast-Bidgoli H, White PJ, Hickson V, Greyson O, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths CJ, Kunst H. Treatment of latent tuberculosis infection in migrants in primary care versus secondary care. Eur Respir J. 2024 Nov 7;64(5):2301733. doi: 10.1183/13993003.01733-2023. Print 2024 Nov.
- Derived from this study: PubMed 31783742Burman M, Copas A, Zenner D, Hickson V, Gosce L, Trathen D, Ashcroft R, Martineau AR, Abubakar I, Griffiths C, Kunst H. Protocol for a cluster randomised control trial evaluating the efficacy and safety of treatment for latent tuberculosis infection in recent migrants within primary care: the CATAPuLT trial. BMC Public Health. 2019 Nov 29;19(1):1598. doi: 10.1186/s12889-019-7983-7.
- Individual participant dataSharing planned: No
Related trials for Latent Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
RecruitingPhase 2/3
Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB
Tuberculosis, Latent
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
Recruiting
Screening With Portable X-rays for Rapid Recognition of TB
Tuberculosis (TB), Tuberculosis Infection, Latent
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.
Heinke Kunst, MD MSc principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community/Primary Care and Hospital/TB Clinic in people with Latent Tuberculosis, run by Queen Mary University of London at 1 site in United Kingdom.
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 9 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: finished, as of the sponsor's last update on 26 Nov 2021. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Completion of Latent Tuberculosis Treatment (time frame: 3 months). 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 NCT03069807, which also lists 2 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 26 Nov 2021.