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The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa (XACT)
This study has been completed.
Sponsor:
University of Cape Town
Collaborators:
University of Zimbabwe
Università degli Studi di Sassari
Radboud University
Information provided by (Responsible Party):
Keertan Dheda, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01990274
First received: October 24, 2013
Last updated: November 24, 2015
Last verified: November 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
| Tuberculosis | Procedure: GeneXpert MTB/RIF assay Procedure: Smear microscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official 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) |
Resource links provided by NLM:
Further study details as provided by Keertan Dheda, University of Cape Town:
Primary Outcome Measures:
- Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy [ Time Frame: 2 months ]The proportion of culture-positive TB cases initiating TB treatment in each study arm.
Secondary Outcome Measures:
- The proportion of culture-positive TB cases completing TB treatment in each study arm [ Time Frame: 6 months ]The number of patients that are enrolled, randomized to a study arm, diagnosed with TB, and completing TB treatment.
- Feasibility of performing Xpert MTB/RIF at the point-of-care in a mobile unit using an alternative power supply [ Time Frame: 6 months ]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.
- Cost per TB case detected between study arms [ Time Frame: 6 months ]Documentation of patient costs for TB diagnosis.
- Cost per TB case successfully completing treatment between study arms [ Time Frame: 6 months ]Documentation of patient costs for completing TB treatment.
- Determining whether LAM is present at sub-ELISA concentrations using mass spectroscopy of urine samples from TB patients [ Time Frame: 6 months ]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.
- Validating the electronic chest X-ray scoring system for Computer Aided Diagnostics (CAD) of TB [ Time Frame: 6 months ]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.
| Enrollment: | 875 |
| Study Start Date: | October 2013 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Novel
Patients in this arm will receive 3 sputum samples for GeneXpert MTB/RIF assay and MGIT liquid TB culture.
|
Procedure: GeneXpert MTB/RIF assay
Automated nucleic-acid amplification test (fully integrated) test for TB
Other Name: Cepheid GeneXpert MTB/RIF
Procedure: Smear microscopy
Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading
|
|
Active Comparator: Standard
Patients in this arm will receive 2 sputum samples for fluorescence smear microscopy and MGIT liquid TB culture.
|
Procedure: Smear microscopy
Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Community participant willing to complete community-based symptom screening, urine testing and/or undergo TB diagnostic tests at the local TB clinic.
- Provision of informed consent.
-
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
- Any HIV+ve adult (older than 18 years).
Exclusion Criteria:
- Inability to provide informed consent (e.g. mentally impaired).
- Patients self-presenting to the TB clinics.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01990274
Please refer to this study by its ClinicalTrials.gov identifier: NCT01990274
Locations
| Italy | |
| University of Sassari | |
| Sassari, Italy, 07100 | |
| Netherlands | |
| Radboud University | |
| Nijmegen, Netherlands, 6500 HB | |
| South Africa | |
| University of Cape Town | |
| Cape Town, Western Province, South Africa, 7945 | |
| Zimbabwe | |
| University of Zimbabwe | |
| Harare, Zimbabwe, P O Box A178 Avondale | |
Sponsors and Collaborators
University of Cape Town
University of Zimbabwe
Università degli Studi di Sassari
Radboud University
Investigators
| Principal Investigator: | Keertan Dheda, MBChB, PhD | University of Cape Town |
More Information
| Responsible Party: | Keertan Dheda, Professor and Head, Lung Infection and Immunity Unit, University of Cape Town |
| ClinicalTrials.gov Identifier: | NCT01990274 History of Changes |
| Other Study ID Numbers: |
XACT.2011.10800.003 |
| Study First Received: | October 24, 2013 |
| Last Updated: | November 24, 2015 |
Keywords provided by Keertan Dheda, University of Cape Town:
|
Tuberculosis Diagnosis GeneXpert MTB/RIF Point-of-treatment Mobile unit |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on July 07, 2017