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GeneXpert Demonstration Study MTB/RIF

The impact of rapid molecular diagnosis of tuberculosis on tuberculosis services and patient care ¿ a cluster randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201010000255244
Enrollment
1700
Registered
2010-10-12
Start date
2010-09-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Tuberculosis

Interventions

Xpert arm
Control arm

Sponsors

University of Cape Town
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All adult patients presenting to the study clinics for TB investigation, including both: 1. Patients with suspected TB; and 2. Patients with suspected drug-resistant TB, including patients suspected of failing TB treatment

Exclusion criteria

Exclusion criteria: Patients currently on TB therapy and undergoing testing for treatment monitoring purposes.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with untreated TB two months after enrolment (untreated TB defined as patients with TB diagnosed by smear or culture at the 2 month follow up visit, but not before, or patients in whom the diagnosis of TB had been confirmed (smear, culture or Xpert) previously but who had not yet commenced TB treatment at the 2 month follow up visit.

Secondary

MeasureTime frame
Time to appropriate TB treatment (defined as time between enrolment and commencement of appropriate first line or drug-resistant TB treatment);Mortality (all cause);Time to diagnosis (defined as the time between enrolment and a confirmed diagnosis of TB based on smear, culture or Xpert);Number of clinic visits prior to appropriate TB treatment

Countries

South Africa

Contacts

Public ContactMark Nicol
Mark.Nicol@uct.ac.za27 21 406 6083

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026