Trial of Point-of-treatment Xpert MTB/RIF Assay
TBNEATXpert
Multicentre Randomised Control Trial of Point-of-treatment (Clinic-based) Xpert MTB/RIF Assay
2 other identifiers
interventional
1,472
2 countries
2
Brief Summary
Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 6, 2013
June 1, 2013
1.8 years
July 7, 2011
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in TB-related Morbidity
Time-specific (2 month) difference in morbidity between the Xpert MTB/RIF and smear microscopy study arms. Morbidity will be assessed using the TB Score and Karnosky performance scale
2 months
Difference in TB-related Morbidity
Time-specific (6 month) difference in morbidity between the Xpert MTB/RIF and smear microscopy study arms. Morbidity will be assessed using the TB Score and Karnosky performance scale
6 months
Secondary Outcomes (5)
Time-to-diagnosis
6 months
Drop-out and lost-to-follow up rates
1 year
Feasibility of clinic-based performance of Xpert MTB/RIF assay performed by nursing staff without formal research training
6 months
Individual patient-level cost analysis, cost-effectiveness evaluation and quality of health indices evaluation
1 year
Time-to-treatment initiation
6 months
Study Arms (2)
Xpert MTB/RIF
EXPERIMENTALPatients in this arm will receive 1 sputum Xpert MTB/RIF test (point-of-treatment) and 1 sputum sample for MGIT liquid TB culture (regional lab)
Sputum smear microscopy
ACTIVE COMPARATORPatients in this study arm will receive 2 sputum samples for same-day smear microscopy and 1 of the sputum samples will have a MGIT Liquid culture (regional lab).
Interventions
Automated nucleic-acid amplification test (fully integrated) test for TB
Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading
Eligibility Criteria
You may qualify if:
- Able and willing to give informed consent
- Ambulant patient presenting to TB clinic
- IF HIV negative requires 2 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
- OR if HIV positive - any one of the following:
- current cough
- night sweats
- fever
- +2 more criteria
You may not qualify if:
- Inability to provide informed consent (e.g. mentally impaired)
- Unable to produce 2 sputa of ≥ 1ml
- TB treatment within the last 60 days
- Unable to potentially return for study follow-up at 2 and 6 months (i.e. leaving community)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cape Townlead
- Biomedical Research and Training Institutecollaborator
- University of Zimbabwecollaborator
- University of Zambiacollaborator
- Medical Research Council, South Africacollaborator
- Mbeya medical research programcollaborator
- McGill Universitycollaborator
- Radboud University Medical Centercollaborator
- University of Cape Town Lung Institutecollaborator
Study Sites (4)
Medical Research Council
Durban, KwaZulu-Natal, South Africa
University of Cape Town
Cape Town, Western Cape, 7945, South Africa
University Teaching Hospital of Zambia
Lusaka, Zambia
University of Zimbabwe
Harare, Zimbabwe
Related Publications (1)
Theron G, Zijenah L, Chanda D, Clowes P, Rachow A, Lesosky M, Bara W, Mungofa S, Pai M, Hoelscher M, Dowdy D, Pym A, Mwaba P, Mason P, Peter J, Dheda K; TB-NEAT team. Feasibility, accuracy, and clinical effect of point-of-care Xpert MTB/RIF testing for tuberculosis in primary-care settings in Africa: a multicentre, randomised, controlled trial. Lancet. 2014 Feb 1;383(9915):424-35. doi: 10.1016/S0140-6736(13)62073-5. Epub 2013 Oct 28.
PMID: 24176144DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keertan Dheda, MD PhD
University of Cape Town
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Head, Lung Infection and Immunity unit
Study Record Dates
First Submitted
July 7, 2011
First Posted
March 15, 2012
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
June 6, 2013
Record last verified: 2013-06