Multicenter Study of the Accuracy and Feasibility of the Xpert Ultra Test

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-5sj53s
• Date of registration: 16/12/2015
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Multicenter Study of the Accuracy and Feasibility of the Xpert Ultra Test
• Scientific title: Multicenter Study of the Accuracy and Feasibility of the Xpert Ultra Test
• Date of first enrolment: 01/01/2016
• Recruitment status: Not yet recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-5sj53s
• Study type: Observational
• Study design: Observational, cross-sectional with limited longitudinal follow-up
• Phase: N/A

Countries of recruitment

Brazil, China, Kenya, South Africa, Uganda

Contacts

• Name: Susan E. Dorman
• Affiliation: Center for TB Research

• Name: Susan E. Dorman
• Affiliation: Center for TB Research

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion Criteria for Case Detection Group
• Age 18 years or above;
• Provision of informed consent;
• Willingness to provide up to 4 sputum specimens at enrollment;
• Willingness to have a study follow-up visit 42 to 70 days after enrollment;
• Clinical suspicion of pulmonary TB (including cough ?2 weeks and at least 1 other symptom typical of TB.

Inclusion Criteria for Drug Resistant TB Group
• Age 18 years or above;
• Provision of informed consent;
• Willingness to provide 3 sputum specimens at enrollment;
• Clinical suspicion of pulmonary TB (including cough ?2 weeks and at least 1 other symptom typical of TB);
• Meets at least one of the following criteria:
A) microbiologically-confirmed pulmonary TB with documented rifampin resistance who has received anti-tuberculosis therapy for 31 days or less;
B) known pulmonary TB with suspected treatment failure;
C) history of drug-resistant TB AND off anti-TB therapy for ? 3 months
Exclusion criteria: Exclusion Criteria for Case Detection Group
• Receipt of more than two doses (two days) of TB treatment within 6 months prior to enrollment;
• Participants for whom, at the time of enrollment, the follow-up visit is judged to be poorly feasible (e.g. individuals planning to relocate).

Exclusion Criteria for Drug Resistant TB Group
• No exclusion criteria


Age minimum: 18Y
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

C01.252.410.040.552.846

Tuberculosis

Intervention(s)

Observational, longitudinal, prospective follow-up, which is expected in Brazil, about 250 people participate in this study. 230 are listed in "Group with TB suspects"; 20 are listed in the "Group with resistant TB Drugs".

The largest group, "group with TB suspects" will be composed of individuals assessed for TB, but who do not know they have TB. After the informed consent process, sputum will be collected on three occasions in the course of two days and tested in the center of the lab. There will be a follow-up visit approximately two months later, and a sputum sample will be collected and tested in the center of the lab.

A smaller group "group with resistant TB Drugs" will be composed of individuals at high risk of drug resistance for treatment of TB, to ensure an adequate number of participants with rifampicin resistant TB for meaningful statistical analysis of the sensitivity of detection Ultra Xpert resistance test.

Device

Z11.1

Primary Outcome(s)

A single Xpert Ultra test will have sensitivity that is non-inferior to that of the Xpert MTB/RIF assay among all culture positive pulmonary TB patients for detection of M. tuberculosis in sputum if the lower limit of the 95% confidence interval for the difference between Xpert Ultra sensitivity and Xpert MTB/RIF sensitivity does not exceed 7.0% using Xpert results from sputum S1.

Secondary Outcome(s)

Enrollment of 100 rifampin resistant TB patients will allow estimation of sensitivity with a precision of +/-12% (95% confidence interval) assuming a sensitivity of between 90% and 98% and will allow estimation of specificity with a precision of +/- 9% (95% confidence interval) for detection of rifampin resistance by Xpert Ultra.

Source(s) of Monetary Support

Núcleo de Doenças Infecciosas

Cepheid

Center for TB Research

National Institute of Allergy and Infectious Diseases (NIAID)

Secondary Sponsor(s)

Center for TB Research

Núcleo de Doenças Infecciosas