Tuberculosis Clinical Trial
— XACTOfficial title:
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa- a Randomized Controlled Trial (XACT)
Verified date | November 2015 |
Source | University of Cape Town |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Human Research Ethics Committee |
Study type | Interventional |
The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.
Status | Completed |
Enrollment | 875 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Community participant willing to complete community-based symptom screening, urine testing and/or undergo TB diagnostic tests at the local TB clinic. 2. Provision of informed consent. 3. HIV-negative adults (older than 18 years) with 1 or more of the following: - cough = 2 weeks - loss of weight - persistent fever = 2 weeks and/or - a single recorded temp > 38°C - night sweats - generalized fatigue - hemoptysis or - chest pain 4. Any HIV+ve adult (older than 18 years). Exclusion Criteria: 1. Inability to provide informed consent (e.g. mentally impaired). 2. Patients self-presenting to the TB clinics. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | University of Sassari | Sassari | |
Netherlands | Radboud University | Nijmegen | |
South Africa | University of Cape Town | Cape Town | Western Province |
Zimbabwe | University of Zimbabwe | Harare |
Lead Sponsor | Collaborator |
---|---|
University of Cape Town | Radboud University, Università degli Studi di Sassari, University of Zimbabwe |
Italy, Netherlands, South Africa, Zimbabwe,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy | The proportion of culture-positive TB cases initiating TB treatment in each study arm. | 2 months | No |
Secondary | The proportion of culture-positive TB cases completing TB treatment in each study arm | The number of patients that are enrolled, randomized to a study arm, diagnosed with TB, and completing TB treatment. | 6 months | No |
Secondary | Feasibility of performing Xpert MTB/RIF at the point-of-care in a mobile unit using an alternative power supply | Feasibility indicators for the performance of Xpert in a mobile unit. These include turn-around-time, user appraisal and assessments and performance comparisons between mobile clinic and laboratory-based Xpert MTB/RIF. | 6 months | No |
Secondary | Cost per TB case detected between study arms | Documentation of patient costs for TB diagnosis. | 6 months | No |
Secondary | Cost per TB case successfully completing treatment between study arms | Documentation of patient costs for completing TB treatment. | 6 months | No |
Secondary | Determining whether LAM is present at sub-ELISA concentrations using mass spectroscopy of urine samples from TB patients | Urine from subjects will be used to verify whether LAM is present in the urine of HIV-infected persons with TB at sub-ELISA concentrations using mass spectrometry. LAM standards will be used in spiked urine samples to evaluate limit of detection and specificity. | 6 months | No |
Secondary | Validating the electronic chest X-ray scoring system for Computer Aided Diagnostics (CAD) of TB | The method employs an automatic scoring algorithm to interpret digitalized chest x-rays. The system is suited to x-rays being done in remote areas where medical expertise is not available. | 6 months | No |
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