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Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis (CATAPULT)

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ClinicalTrials.gov Identifier: NCT03069807
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
University College, London
Public Health England
Information provided by (Responsible Party):
Queen Mary University of London

Brief 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.

Condition or disease Intervention/treatment Phase
Latent Tuberculosis Other: Community/Primary Care Other: Hospital/TB Clinic Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Can Latent Tuberculosis Infection (LTBI) in Recent Migrants be Treated Effectively and Safely in Primary Care? A Cluster Randomised Controlled Trial.
Actual Study Start Date : September 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants with LTBI will be treated in the Community/Primary Care.
Other: Community/Primary Care
The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists

Active Comparator: Control
Participants with LTBI will be treated in the Hospital/TB Clinic
Other: Hospital/TB Clinic
The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Complete of Latent Tuberculosis Treatment [ Time Frame: 3 months ]
    Based on patients taking at least 80 or 85 percent of doses during 3 months of treatment.

  2. Adherence to Treatment [ Time Frame: 3 months ]
    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.

  3. Acceptability of Treatment [ Time Frame: 3 months ]
    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.

  4. Adverse Effects of Treatment [ Time Frame: 3 months ]
    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.

  5. Active Tuberculosis [ Time Frame: 2 years ]
    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.

  6. Patient Satisfaction [ Time Frame: 3 months ]
    Assessed using a standardised non-validated questionnaire (Likert scale)

  7. Cost-effectiveness of Treatment [ Time Frame: 2 years ]
    Assessed using a health economic model that includes locally and nationally agreed tariffs for latent tuberculosis treatment.

  8. Patient Knowledge [ Time Frame: 3 months ]
    The impact of patients knowledge about Latent Tuberculosis on treatment acceptance and completion will be assessed at baseline using a standardised non-validated questionnaire.



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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  1. Pregnant or breastfeeding women
  2. Patients requiring medications that cannot be safely taken with Rifinah
  3. HIV infection.
  4. Individuals with known liver disease, or abnormal liver function tests (LFTs)
  5. Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
  6. Chronic or active hepatitis B or hepatitis C virus infection
  7. Previous treatment for TB or LTBI.
  8. 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
  9. Evidence of active TB

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069807


Contacts
Contact: Heinke Kunst, MD MSc h.kunst@qmul.ac.uk
Contact: Matthew GK Burman, MA MBChB 00442078823448 m.burman@qmul.ac.uk

Locations
United Kingdom
Shrewsbury Road Health Centre Recruiting
London, United Kingdom, E7 8QP
Contact: Heinke Kunst       h.kunst@qmul.ac.uk   
Contact: Matthew Burman       m.burman@qmul.ac.uk   
Sponsors and Collaborators
Queen Mary University of London
University College, London
Public Health England
Investigators
Principal Investigator: Heinke Kunst, MD MSc Queen Mary University of London

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03069807     History of Changes
Other Study ID Numbers: 4212301
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections