The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT01990274
• Date of registration: 24/10/2013
• Prospective Registration: No
• Primary sponsor: University of Cape Town
• Public title: The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa XACT
• Scientific 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)
• Date of first enrolment: October 2013
• Target sample size: 875
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01990274
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

Italy, Netherlands, South Africa, Zimbabwe

Contacts

• Name: Keertan Dheda, MBChB, PhD
• Affiliation: University of Cape Town

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Procedure: Smear microscopy

Procedure: GeneXpert MTB/RIF assay

Primary Outcome(s)

Comparison of novel intensive-case finding diagnostic tools to standard intensive-case finding strategy [Time Frame: 2 months]

Secondary Outcome(s)

Feasibility of performing Xpert MTB/RIF at the point-of-care in a mobile unit using an alternative power supply [Time Frame: 6 months]

Determining whether LAM is present at sub-ELISA concentrations using mass spectroscopy of urine samples from TB patients [Time Frame: 6 months]

Cost per TB case successfully completing treatment between study arms [Time Frame: 6 months]

Cost per TB case detected between study arms [Time Frame: 6 months]

Validating the electronic chest X-ray scoring system for Computer Aided Diagnostics (CAD) of TB [Time Frame: 6 months]

The proportion of culture-positive TB cases completing TB treatment in each study arm [Time Frame: 6 months]

Secondary ID(s)

XACT.2011.10800.003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Università degli Studi di Sassari

Radboud University

University of Zimbabwe