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

NCT01990274 | Completed DMC

• 1 other identifier: XACT.2011.10800.003
• Study Type: interventional
• Target: 875
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Tuberculosis

Keywords

Tuberculosis; Diagnosis; GeneXpert MTB/RIF; Point-of-treatment; Mobile unit

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The proportion of culture-positive TB cases completing TB treatment in each study arm

  6 months

• Feasibility of performing Xpert MTB/RIF at the point-of-care in a mobile unit using an alternative power supply

  6 months

• Cost per TB case detected between study arms

  6 months

• Cost per TB case successfully completing treatment between study arms

  6 months

• Determining whether LAM is present at sub-ELISA concentrations using mass spectroscopy of urine samples from TB patients

  6 months

Study Arms (2)

Novel

EXPERIMENTAL

Patients in this arm will receive 3 sputum samples for GeneXpert MTB/RIF assay and MGIT liquid TB culture.

Procedure: GeneXpert MTB/RIF assay; Procedure: Smear microscopy

Standard

ACTIVE COMPARATOR

Patients in this arm will receive 2 sputum samples for fluorescence smear microscopy and MGIT liquid TB culture.

Procedure: Smear microscopy

Interventions

GeneXpert MTB/RIF assay PROCEDURE

Automated nucleic-acid amplification test (fully integrated) test for TB

Also known as: Cepheid GeneXpert MTB/RIF

Novel

Smear microscopy PROCEDURE

Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading

Novel; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Inability to provide informed consent (e.g. mentally impaired).
• Patients self-presenting to the TB clinics.

Sponsors & Collaborators

• University of Cape Town: lead
• University of Zimbabwe: collaborator
• Università degli Studi di Sassari: collaborator
• Radboud University Medical Center: collaborator

Study Sites (4)

University of Sassari

Sassari, 07100, Italy

Location

Radboud University

Nijmegen, 6500 HB, Netherlands

Location

University of Cape Town

Cape Town, Western Province, 7945, South Africa

Location

University of Zimbabwe

Harare, P O Box A178 Avondale, Zimbabwe

Location

Related Publications (1)

• Calligaro GL, Zijenah LS, Peter JG, Theron G, Buser V, McNerney R, Bara W, Bandason T, Govender U, Tomasicchio M, Smith L, Mayosi BM, Dheda K. Effect of new tuberculosis diagnostic technologies on community-based intensified case finding: a multicentre randomised controlled trial. Lancet Infect Dis. 2017 Apr;17(4):441-450. doi: 10.1016/S1473-3099(16)30384-X. Epub 2017 Jan 5.

  PMID: 28063795 DERIVED

Related Links

• XACT website

MeSH Terms

Conditions

Tuberculosis; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keertan Dheda, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Lung Infection and Immunity Unit

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 21, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

IT (1); NL (1); ZA (1); ZI (1)