Impact of a novel molecular tuberculosis (TB) diagnostic system in patients at high risk of TB mortality in rural South Africa

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18642314

Enrollment

2000

Registered

2011-06-17

Start date

2011-07-04

Completion date

Unknown

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary tuberculosis Infections and Infestations Tuberculosis

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. TB suspect (defined as cough of any duration) 2. Age 18 years or older 3. Confirmed human immunodeficiency virus (HIV) infection and/or high risk for multi-drug-resistant tuberculosis (MDR-TB)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of TB cases initiated on appropriate TB treatment within 30 days of enrolment	—

Secondary

Measure	Time frame
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)	—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026