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Improving TB Diagnosis and Treatment Through Basic, Applied and Health Systems Research (BAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03356925
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Grant Theron, University of Stellenbosch

Brief Summary:

TB is a global health problem and in South Africa rates as the second most important problem in terms of Burden of Disease. There are many reasons for this, among which are diagnostic difficulties, extended treatments, drug resistance and health care provision. This application is concerned with all these drivers and will focus activities on a clinic which provides basic care in a very deprived socio-economic area of greater Cape Town, South Africa.

Patients studied in routine, but demanding environments are our focus as these clinics are representative of many areas where TB (and HIV) are found at high prevalence. If the constraints of working in such areas can be understood and appropriate changes that work made, the investigators believe the outputs and policy changes generated in this study will contribute to future success in other settings.

The investigators wish to study the implementation of the Xpert®MTB/RIF (Xpert) and Xpert Ultra (Ultra) systems in situ using a randomised controlled trial design, as opposed to a remote site (central laboratory), to assess whether time to diagnosis can be improved using point of care (POC). The investigators wish to maximise this opportunity by collecting biological samples from a patient population experiencing a TB epidemic for the evaluation of future TB diagnostics.

Using human DNA, the investigators will attempt to determine reasons for poor or no treatment response. Two possibilities exist for this: a) the M. tuberculosis strain is resistant to the drug in question or b) the patient is highly susceptible to the bacterium. The investigators will determine the exome sequences of study participants with susceptible M. tuberculosis strains who show poor or no response, and compare this with rapid responders. Using 16S rRNA sequencing, the investigators will also observe how the microbiome of TB patients is altered during TB treatment and how this is associated with treatment outcome, as well as after TB treatment.

This project will set the foundation for the implementation of new POC TB diagnostic technologies in clinics in South Africa. The biobanked specimens collected can be rapidly utilised for nascent technologies. Studying the patient microbiome will provide insights into what makes some patients more susceptible to TB and what microbiological changes occur during the course of anti-TB treatment.

Condition or disease Intervention/treatment Phase
Tuberculosis Diagnostic Test: Xpert Ultra Point of Care testing Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Feasibility, Accuracy, and Effect of Point-of-care Xpert MTB/RIF Ultra and Xpert MTB/RIF Ultra Testing in Patients Suspected of Having TB: a Randomised Controlled Trial
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
No Intervention: Centralised Xpert®Ultra testing
Patients are selected to receive the standard of care for TB diagnosis at a centralised laboratory facility
Active Comparator: Xpert Ultra Point of Care testing
Patients are selected to receive the point of care for TB diagnosis at the clinic facility they are visiting
Diagnostic Test: Xpert Ultra Point of Care testing
The intervention is the point of care Xpert Ultra TB diagnostic compared to the standard of care centralised TB testing at a centralised facility

Primary Outcome Measures :
  1. Treatment time [ Time Frame: Up to 8 weeks ]
    Time-specific proportion of patients starting TB treatment (all patients and confirmed cases) in centralised diagnosis and treatment arm compared to POC arm.

Secondary Outcome Measures :
  1. TB diagnosis time [ Time Frame: Up to 8 weeks ]
    Time-specific proportion of patients diagnosed in centralised vs POC arm

  2. Time specific yield of Xpert Ultra [ Time Frame: Up to 8 weeks ]
    Proportion of patients who are Xpert Ultra positive

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient is willing to provide specimens (sputum, urine, blood, stool, buccal+ periodontal swab)
  • The patient is clinically suspected of having TB (Two WHO TB symptoms for HIV negative patients and one WHO TB symptom if HIV positive)

Exclusion Criteria:

  • The patient is under the age of 18 years old
  • The patient declines consent
  • The patient has too few clinical symptoms for 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 identifier (NCT number): NCT03356925

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Contact: Grant Theron, PhD (+27) 021 938 9693 ext 9693
Contact: Byron WP Reeve, PhD (+27) 021 938 9954 ext 9954

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South Africa
Scottsdene Clinic Recruiting
Cape Town, Western Cape, South Africa, 7570
Contact: Grant Theron, PhD    (+27) 21 938 9693 ext 9693   
Contact: Byron WP Reeve, PhD    (+27) 21 938 9954 ext 9954   
Wallacedene Clinic Recruiting
Cape Town, Western Cape, South Africa, 7570
Contact: Grant Theron, PhD    (+27) 21 938 9693 ext 9693   
Contact: Byron WP Reeve, PhD    (+27) 21 938 9954 ext 9954   
Sponsors and Collaborators
University of Stellenbosch
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Principal Investigator: Grant Theron, PhD University of Stellenbosch

Additional Information:

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Responsible Party: Grant Theron, Associate Professor, University of Stellenbosch Identifier: NCT03356925     History of Changes
Other Study ID Numbers: N14/10/13
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Grant Theron, University of Stellenbosch:
Xpert®MTB/RIF Ultra
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections