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Impact of a novel molecular tuberculosis (TB) diagnostic system in patients at high risk of TB mortality in rural South Africa
DOI 10.1186/ISRCTN18642314
ClinicalTrials.gov identifier
EudraCT number
Public title Impact of a novel molecular tuberculosis (TB) diagnostic system in patients at high risk of TB mortality in rural South Africa
Scientific title Impact of a novel molecular tuberculosis (TB) diagnostic system in patients at high risk of TB mortality in rural South Africa: a pragmatic cluster randomised controlled trial
Acronym N/A
Serial number at source Wellcome Trust grant number 090999/Z/09/Z, South African National Clinical Trials Registry DOH-27-0711-3568
Study hypothesis Timely initiation of appropriate tuberculosis (TB) treatment will be improved when the diagnostic system is positioned at the primary health care clinic (point-of-care) compared to when it is positioned centrally at the district hospital laboratory
Lay summary Lay summary under review 3
Ethics approval 1. University of KwaZulu-Natal Biomedical Research Ethics Committee (BF033/11)
2. London School of Hygiene and Tropical Medicine Ethics Committee (5926)
Approval pending as of 15/06/2011
Study design Single-centre cluster randomised controlled trial
Countries of recruitment South Africa
Disease/condition/study domain Pulmonary tuberculosis
Participants - inclusion criteria 1. TB suspect (defined as cough of any duration)
2. Age 18yrs or older
3. Confirmed human immunodeficiency virus (HIV) infection and/or high risk for multi-drug-resistant tuberculosis (MDR-TB)
Participants - exclusion criteria 1. Severely unwell requiring admission to hospital
2. Previous MDR/extensively drug-resistant tuberculosis (XDR-TB) diagnosis or treatment
3. Diagnosis or suspicion of extra-pulmonary TB only
4. Unable to give informed consent
Anticipated start date 04/07/2011
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2000
Interventions Comparison between two delivery strategies for the GeneXpert system and Xpert MTB/RIF test: Positioning at district hospital vs positioning at primary health care clinic
Primary outcome measure(s) Proportion of TB cases initiated on appropriate TB treatment within 30 days of enrolment
Secondary outcome measure(s) 1. Time to initiation of appropriate TB treatment
2. Time to initiation of appropriate MDR-TB treatment
3. All-cause mortality at 60 days
4. Hospital admissions in first 60 days
5. Time to initiation of antiretroviral therapy (for eligible HIV-infected participants)
Sources of funding Wellcome Trust (UK) (090999/Z/09/Z)
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23758662
Contact name Dr  Richard  Lessells
  Address Africa Centre for Health and Population Studies
PO Box 198
  City/town Mtubatuba
  Zip/Postcode 3935
  Country South Africa
  Tel +27 (0)35 550 7500
  Fax +27 (0)35 550 7565
  Email rlessells@africacentre.ac.za
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address Research Grants & Contracts Office
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7927 2626
  Fax +44 (0)20 7580 5636
  Email patricia.henley@lshtm.ac.uk
  Sponsor website: http://www.lshtm.ac.uk
Date applied 15/06/2011
Last edited 25/10/2013
Date ISRCTN assigned 17/06/2011
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