Omni/Ultra trial

Cepheid GeneXpert®Omni combined with the Xpert® MTB/RIF Ultra for detection of tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis at primary-level diagnostic centres in Tanzania: a pragmatic, cluster-randomized controlled trial (short title: Omni/Ultra Trial)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201704002117402

Enrollment

1600

Registered

2017-03-21

Start date

2017-09-04

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

GeneXpert Omni combined with Xpert MTB/RIF Ultra for diagnosis of TB

Smear microscopy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult 18 years old and above presumptive TB patients Ability to produce sputum

Exclusion criteria

Exclusion criteria: Presumptive TB patients with symptoms only attributable to extra-pulmonary TB

Design outcomes

Primary

Measure	Time frame
Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 60 days of enrolment;Additionally notified TB cases during intervention compared to the standard of care (direct yield)	—

Secondary

Measure	Time frame
Proportion of participants completing testing with microbiological tests;Proportion diagnosed with microbiologically confirmed TB;Time to treatment initiation based on microbiologically confirmed TB diagnosis;Proportion diagnosed with TB (either microbiologically or clinically);Time to TB treatment initiation based on either microbiologically or clinically diagnosed TB;Death or pre-treatment LTFU;Death or overall LTFU	—

Measure

Time frame

Proportion of participants completing testing with microbiological tests;Proportion diagnosed with microbiologically confirmed TB;Time to treatment initiation based on microbiologically confirmed TB diagnosis;Proportion diagnosed with TB (either microbiologically or clinically);Time to TB treatment initiation based on either microbiologically or clinically diagnosed TB;Death or pre-treatment LTFU;Death or overall LTFU

—

Countries

United Republic of Tanzania

Contacts

Public ContactFrancis Mhimbira

Research scientist/ Ifakara Health Institute

fharaka@ihi.or.tz+255 222 774 756

Outcome results

None listed

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