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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04568967
Other study ID # TB043-3/1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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