TB-CAPT EXULTANT - HIV

Tuberculosis Clinical Trial

Official title:

Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04568967
• Other study ID #: TB043-3/1
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: Adam Penn-Nicholson, PhD
• Phone: +41 22 710 05 91
• Email: Adam.Penn-Nicholson[@]finddx.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.

Description:

To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations.

to assess the impact of this screening strategy on 2-month all-cause mortality.

• to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1172
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults (18 years old and above)

2. Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)

3. Admitted to the hospital (adult medical wards) at the time of enrolment.

Exclusion Criteria:

1. Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)

2. Living outside the catchment area of the participating hospital(s)

3. with plans to migrate outside the catchment area within 2 months after recruitment.

4. Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment

5. Receiving preventive TB treatment in the preceding 6 months

6. Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.

7. Referred from other hospital.

Related Conditions & MeSH terms

• Coinfection
• Diagnoses Disease
• Disease
• HIV Coinfection
• HIV Infections
• Tuberculosis

Intervention

Diagnostic Test:
• Concentrated urine with Xpert Ultra
Molecular TB diagnostic test on urine
• Stool with Xpert Ultra
Molecular TB diagnostic test on stool

Locations

Country	Name	City	State
Mozambique	Centro de Investigação em Saúde de Manhiça-Fundação	Manhiça	Vila Da Manhiça
Mozambique	Instituto Nacional de Saúde (INS)	Maputo
Tanzania	Ifakara Health Institute (IHI)	Bagamoyo
Tanzania	National Institute of Medical Research (NIMR)	Mbeya

Sponsors (11)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	African Society for Laboratory Medicine, Barcelona Institute for Global Health, Centro de Investigação em Saúde de Manhiça, Heidelberg University, Ifakara Health Institute, Instituto Nacional de Saúde, Mozambique, Ludwig-Maximilians - University of Munich, National Institute for Medical Research, Tanzania, Ospedale San Raffaele, Swiss Tropical & Public Health Institute

Countries where clinical trial is conducted

Mozambique,  Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment	The proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment, separately for intervention and control arm. The numerator is the number of participants per study arm who are diagnosed with microbiologically confirmed TB and start on treatment within 72 hours of enrolment. The denominator is the number of participants enrolled per study arm. We will compare this indicator between both study arms.	72 hours after enrolment
Secondary	Eight-week all-cause mortality	Eight-week all-cause mortality (main secondary endpoint) among all participants enrolled. The numerator will be number of deaths during eight weeks after enrolment, the denominator is the number of participants enrolled. We will compare this indicator between both study arms.	8 weeks after enrolment
Secondary	The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.	The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. The numerator is the number of participants diagnosed with TB (with or without bacteriological confirmation) who started treatment within 72 hours of enrolment; the denominator is the number of participants enrolled.	72 hours after enrolment