Back to resultsTB-CAPT EXULTANT - HIV
Primary Purpose
Tuberculosis, HIV Coinfection, Diagnoses Disease
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Concentrated urine with Xpert Ultra
Stool with Xpert Ultra
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- Adults (18 years old and above)
- Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
- Admitted to the hospital (adult medical wards) at the time of enrolment.
Exclusion Criteria:
- Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
- Living outside the catchment area of the participating hospital(s)
- with plans to migrate outside the catchment area within 2 months after recruitment.
- Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
- Receiving preventive TB treatment in the preceding 6 months
- Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
- Referred from other hospital.
Sites / Locations
- Centro de Investigação em Saúde de Manhiça-FundaçãoRecruiting
- Instituto Nacional de Saúde (INS)Recruiting
- Ifakara Health Institute (IHI)Recruiting
- National Institute of Medical Research (NIMR)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention arm
control arm
Arm Description
The intervention arm for this trial consists of HIV patients with TB testing performed regardless of presence of TB symptoms. Testing will be done on expectorated sputum, stool and concentrated urine with Ultra, and urine with AlereLAM. To fulfil exploratory objectives, we will also collect and store 2x tongue swabs for molecular TB diagnostic assay (Xpert Ultra and/or LumiraDx) testing, blood for testing with CRP, and urine samples which will be stored for retrospective FujiLAM testing and analysis.
The control arm for this trial will consist of patients managed according to the current WHO recommended TB testing practices for HIV positive inpatients (as of Q1 2020). TB testing will be done as follows: Sputum Ultra performed whenever the patient has cough, fever, weight loss over night sweats and/or Ultra performed on any tissue (including lymph nodes) from patients with clinical suspicion of extrapulmonary TB. and/or: Urine Alere TB-LAM performed if patients have signs and symptoms of TB (pulmonary and/or extrapulmonary), or with advanced HIV disease, or who are seriously ill, or else irrespective of signs and symptoms of TB, but combined with a CD4 cell count of less than 200 cells/mm .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04568967
First Posted
September 23, 2020
Last Updated
November 30, 2022
Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ludwig-Maximilians - University of Munich, Instituto Nacional de Saúde, Mozambique, Centro de Investigação em Saúde de Manhiça, National Institute for Medical Research, Tanzania, Ifakara Health Institute, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, African Society for Laboratory Medicine, Heidelberg University, Barcelona Institute for Global Health
1. Study Identification
Unique Protocol Identification Number
NCT04568967
Brief Title
TB-CAPT EXULTANT - HIV
Official Title
Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Innovative New Diagnostics, Switzerland
Collaborators
Ludwig-Maximilians - University of Munich, Instituto Nacional de Saúde, Mozambique, Centro de Investigação em Saúde de Manhiça, National Institute for Medical Research, Tanzania, Ifakara Health Institute, Ospedale San Raffaele, Swiss Tropical & Public Health Institute, African Society for Laboratory Medicine, Heidelberg University, Barcelona Institute for Global Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, HIV Coinfection, Diagnoses Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
The intervention arm for this trial consists of HIV patients with TB testing performed regardless of presence of TB symptoms. Testing will be done on expectorated sputum, stool and concentrated urine with Ultra, and urine with AlereLAM.
To fulfil exploratory objectives, we will also collect and store 2x tongue swabs for molecular TB diagnostic assay (Xpert Ultra and/or LumiraDx) testing, blood for testing with CRP, and urine samples which will be stored for retrospective FujiLAM testing and analysis.
Arm Title
control arm
Arm Type
No Intervention
Arm Description
The control arm for this trial will consist of patients managed according to the current WHO recommended TB testing practices for HIV positive inpatients (as of Q1 2020).
TB testing will be done as follows:
Sputum Ultra performed whenever the patient has cough, fever, weight loss over night sweats and/or Ultra performed on any tissue (including lymph nodes) from patients with clinical suspicion of extrapulmonary TB.
and/or: Urine Alere TB-LAM performed if patients have signs and symptoms of TB (pulmonary and/or extrapulmonary), or with advanced HIV disease, or who are seriously ill, or else irrespective of signs and symptoms of TB, but combined with a CD4 cell count of less than 200 cells/mm .
Intervention Type
Diagnostic Test
Intervention Name(s)
Concentrated urine with Xpert Ultra
Intervention Description
Molecular TB diagnostic test on urine
Intervention Type
Diagnostic Test
Intervention Name(s)
Stool with Xpert Ultra
Intervention Description
Molecular TB diagnostic test on stool
Primary Outcome Measure Information:
Title
proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment
Description
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.
Time Frame
72 hours after enrolment
Secondary Outcome Measure Information:
Title
Eight-week all-cause mortality
Description
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.
Time Frame
8 weeks after enrolment
Title
The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.
Description
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.
Time Frame
72 hours after enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (18 years old and above)
Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)
Admitted to the hospital (adult medical wards) at the time of enrolment.
Exclusion Criteria:
Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)
Living outside the catchment area of the participating hospital(s)
with plans to migrate outside the catchment area within 2 months after recruitment.
Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment
Receiving preventive TB treatment in the preceding 6 months
Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.
Referred from other hospital.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Penn-Nicholson, PhD
Phone
+41 22 710 05 91
Email
Adam.Penn-Nicholson@finddx.org
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Ruhwald, MD,PhD
Phone
+41 22 710 05 91
Email
Morten.Ruhwald@finddx.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto García-Basteiro, MD
Organizational Affiliation
Barcelona Institute for Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigação em Saúde de Manhiça-Fundação
City
Manhiça
State/Province
Vila Da Manhiça
ZIP/Postal Code
1929
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinis Nguenha, MD, MSC
Phone
+258 21 81 00 02/181
Email
dinis.nguenha@manhica.net
Facility Name
Instituto Nacional de Saúde (INS)
City
Maputo
ZIP/Postal Code
1100
Country
Mozambique
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celso Khosa, MD, PhD
Phone
+258 21431103
Email
celso.khosa@ins.gov.mz
Facility Name
Ifakara Health Institute (IHI)
City
Bagamoyo
ZIP/Postal Code
53502
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Ndege, MD, MSc
Phone
+255 23 233 3448
Email
rndege@ihi.or.tz
Facility Name
National Institute of Medical Research (NIMR)
City
Mbeya
ZIP/Postal Code
2410
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nyanda Ntinginya, MD, PhD
Phone
+255 25 2503364
Email
nelias@nimr-mmrc.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual, de-identified participant data may be shared, including data dictionaries. Available documents include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date, will be shared with anyone who wishes to access them, and will be available for any purpose of analyses.
IPD Sharing Time Frame
After publication of the primary peer-reviewed manuscript
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TB-CAPT EXULTANT - HIV
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