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 centers in Tanzania: a pragmatic, cluster-randomized controlled trial
GeneXpert Omni (Omni) is a new developed diagnostic tool with characteristic suitable for use in resource limited settings e.g. portability, battery powered. The GeneXpert Omni is considered the next generation of the current existing GeneXpert platform and is developed to address challenges encountered by the current GeneXpert platform in resource limited settings. A new cartridge, Xpert MTB/RIF Ultra (Ultra) has been developed with higher sensitivity approximately similar to culture, the gold standard for tuberculosis (TB) diagnosis. The combination of both Omni and Ultra is expected to impact on important clinical outcomes and hence control TB. The Omni/Ultra trial is pragmatic cluster randomized trial which will evaluate Omni combined with Ultra for TB detection in primary healthcare facilities in Bagamoyo and Dar es Salaam in Tanzania. Fourteen clusters (primary healthcare facilities), seven in each arm, fulfilling inclusion criteria, will be randomized to either the intervention (Omni/Ultra) or remain on standard of care (smear microscopy) for diagnosis of TB. Presumptive TB patients attending selected facilities will undergo diagnostic procedures of TB test using Omni/Ulta or smear microscopy as per randomization arm. Omni/Ultra is planned to recruit 1600 presumptive adult TB patients, who are able to produce sputum. The trial is expected run for 18 months. The primary ends points are;
- 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)
Omni/Ultra is an investigator initiated trial, implemented by the Ifakara Health Institute in collaboration with the Swiss Tropical and Public Health Institute and the National TB program Tanzania. Omni/Ultra trial is funded by both the STOP TB Partneship|TB REACH initiative and the Foundation for Innovative New Diagnostics.