Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201704002117402 Date of Approval: 21/03/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Omni/Ultra trial
Official scientific title 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)
Brief summary describing the background and objectives of the trial Xpert MTB/RIF, a novel automated real-time PCR-based technology for TB diagnosis, has been implemented and scaled up in TB endemic countries. Most pragmatic trials embedded into the national TB control programmes in those countries could not demonstrate the expected impact of Xpert MTB/RIF on mortality, TB-related morbidity, treatment delay or TB treatment outcome. The main obstacles for the use in remote, decentralized settings are the need for specifically trained personnel, a stable and uninterrupted power supply, a controlled operating temperature, and for regular maintenance and calibration. Sensitivity of Xpert MTB/RIF in patients presenting with smear negative TB is limited. Therefore a next-generation diagnostic tool should be more sensitive than Xpert MTB/RIF hence contribute to detect more TB cases and decrease the time to diagnosis and treatment. Ideally, presumptive TB cases should be tested in decentralized facilities close to the homes of the patients. Furthermore, the evaluation of new diagnostic tools should include the assessment of incremental value, including the ease of use, acceptability among healthcare workers and the cost-effectiveness compared to the standard use of smear microscopy in primary healthcare settings The new battery-powered, point-of-care Cepheid GeneXpert®Omni (Omni) platform combined with the new highly-sensitive Xpert® MTB/RIF Ultra (Ultra) assay has the potential to overcome the limitations of Xpert MTB/RIF by providing molecular TB testing with a sensitivity comparable to culture in peripheral facilities under challenging environmental condition. The presented trial will assess the incremental value of Omni/Ultra compared to routine smear microscopy by analyzing a broad range of important patient study endpoints. Furthermore, important aims are the analysis on acceptability and ease of use as well as cost-effectiveness of using Omni/Ultra in primary healthcare facilities in Tanzania will be done
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Omni Ultra trial
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 04/09/2017
Actual trial start date
Anticipated date of last follow up 28/02/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL www.ihi.or.tz
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Computer generated sequence will be used to allocate clusters into either intervention or control arm All participant in a cluster will receive either the intervention or standard of care for the control. Randomization is done at cluster level Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Computer generated sequence will be used to allocate clusters into either intervention or control arm All participant in a cluster will receive either the intervention or standard of care for the control. Randomization is done at cluster level Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GeneXpert Omni combined with Xpert MTB/RIF Ultra for diagnosis of TB Once One year Presumptive TB patients attending clusters in the intervention arm will receive Omni/Ultra test for TB detection 800
Control Group Smear microscopy once once Presumptive TB patients attending clusters in the control arm will receive smear microscopy test for TB detection which is the standard of care 800 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult 18 years old and above presumptive TB patients Ability to produce sputum Presumptive TB patients with symptoms only attributable to extra-pulmonary TB 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 17/02/2017 Ifakara Health Institute Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Plot 463, Kiko Avenue Mikocheni Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 18/04/2017 Medical Research Coordinating committee of the National Medical Research (NIMR)
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 18/04/2017 Tanzania Food and Drug Authority (TFDA)
Ethics Committee Address
Street address City Postal code Country
Off Mandela Road, Mabibo- External Dar es Salaam Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Proportion of participants who have bacteriologically confirmed TB and have TB therapy initiated within 60 days of enrolment two months since enrollment in the study
Primary Outcome Additionally notified TB cases during intervention compared to the standard of care (direct yield) end ofrecruitment
Secondary Outcome Proportion of participants completing testing with microbiological tests end of recruitment
Secondary Outcome Proportion diagnosed with microbiologically confirmed TB end of recruitment
Secondary Outcome Time to treatment initiation based on microbiologically confirmed TB diagnosis end of recruitment
Secondary Outcome Proportion diagnosed with TB (either microbiologically or clinically) end of recruitment
Secondary Outcome Time to TB treatment initiation based on either microbiologically or clinically diagnosed TB end of recruitment
Secondary Outcome Death or pre-treatment LTFU at 180 days since enrollment
Secondary Outcome Death or overall LTFU at 180 days since enrollment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbezi primary healthcare facilty Mbezi Dar es Salaam United Republic of Tanzania
Kawe primary healthcare facilty Kawe Dar es Salaam United Republic of Tanzania
Kunduchi primary healthcare facility Kunduchi Dar es Salaam United Republic of Tanzania
Makuburi primary healthcare facility Makuburi Dar es Salaam United Republic of Tanzania
Bunju primary healthcare facility Bunju Dar es Salaam United Republic of Tanzania
Kiwangwa primary healthcare facility Kiwangwa Bagamoyo United Republic of Tanzania
Pande primary healthcare facility Pande Bagamoyo United Republic of Tanzania
Kimara primary healthcare facility Kimara Dar es Salaam United Republic of Tanzania
St Elizabeth primary healthcare facility St Elizabeth Bagamoyo District United Republic of Tanzania
Miono primary healthcare facility Miono Bagamoyo District United Republic of Tanzania
Msata primary healthcare facility Msata Bagamoyo District United Republic of Tanzania
Ubena estate primary healthcare facility Ubena estate Bagamoyo District United Republic of Tanzania
Tegeta primary healthcare facility Tegeta Dar es Salaam United Republic of Tanzania
Mburahati primary healthcare facility Mburahati Dar es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Foundation for Innovative New Diagnostics (FIND) 9 Chemin des Mines ¿ 1202 Geneva, Switzerland Geneva 1202 Switzerland
STOP TB| TB REACH Chemin de Blandonnet 2 Geneva 1214 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ifakara Health Institute Plot 463, Kiko Avenue Mikocheni Dar es salaam Tanzania Charities/Societies/Foundation
Primary Sponsor Foundation for Innovative New Diagnostics 9 Chemin des Mines Geneva 1202 Switzerland Charities/Societies/Foundation
Secondary Sponsor Swiss Tropical and Public Health Institute Socinstrasse 57, 4051 Basel, Switzerland Basel 4051 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
National TB and Leprosy Control Programme 10th Floor, Extelecom Building, Samora Avenue Dar es salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frederick Haraka fharaka@ihi.or.tz +255 222 774 756 Kiko Avenue
City Postal code Country Position/Affiliation
Dar es salaam Tanzania Research scientist
Role Name Email Phone Street address
Public Enquiries Francis Mhimbira fharaka@ihi.or.tz +255 222 774 756 Kiko Avenue
City Postal code Country Position/Affiliation
Dar es salaam Tanzania Research scientist/ Ifakara Health Institute
Role Name Email Phone Street address
Scientific Enquiries Klaus Reither klaus.reither@unibas.ch +255 222 774 756 Kiko Avenue
City Postal code Country Position/Affiliation
Dar es salaam Tanzania TB team leader/Swiss Tropical and public health insitute
Role Name Email Phone Street address
Scientific Enquiries Frederick Haraka fharaka@ihi.or.tz +255 222 774 756 Kiko Avenue
City Postal code Country Position/Affiliation
Dar es salaam Tanzania Research scientist
REPORTING
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