Please select the arm or intervention descriptions that belong to the clinical trial below.
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
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.


Options:
A: Arm Label: Centralised Xpert®Ultra testing; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Xpert Ultra Point of Care testing; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: Xpert Ultra Point of Care testing | Intervention Type: DIAGNOSTIC_TEST; Name: Xpert Ultra Point of Care testing; Assigned to Arm(s): Xpert Ultra Point of Care testing
B: Arm Label: Community level screening; Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: Screening at community level | Arm Label: Community level screening: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Diagnostic Test: Screening at community level | Intervention Type: DIAGNOSTIC_TEST; Name: Screening at community level; Assigned to Arm(s): Community level screening: Arm 2, Community level screening; Arm 1
C: Arm Label: Novel; Type: EXPERIMENTAL; Interventions: Procedure: GeneXpert MTB/RIF assay, Procedure: Smear microscopy | Arm Label: Standard; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Smear microscopy | Intervention Type: PROCEDURE; Name: GeneXpert MTB/RIF assay; Assigned to Arm(s): Novel | Intervention Type: PROCEDURE; Name: Smear microscopy; Assigned to Arm(s): Novel, Standard
D: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Test-and-Treat Intervention; Type: ACTIVE_COMPARATOR; Interventions: Other: Test-and-Treat TB | Intervention Type: OTHER; Name: Test-and-Treat TB; Assigned to Arm(s): Test-and-Treat Intervention

Answer: A