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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04568967




Registration number
NCT04568967
Ethics application status
Date submitted
23/09/2020
Date registered
29/09/2020

Titles & IDs
Public title
TB-CAPT EXULTANT - HIV
Scientific title
Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa
Secondary ID [1] 0 0
TB043-3/1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tuberculosis 0 0
HIV Coinfection 0 0
Diagnoses Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Concentrated urine with Xpert Ultra
Diagnosis / Prognosis - Stool with Xpert Ultra

Experimental: intervention arm - 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.

No intervention: control arm - 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 .


Diagnosis / Prognosis: Concentrated urine with Xpert Ultra
Molecular TB diagnostic test on urine

Diagnosis / Prognosis: Stool with Xpert Ultra
Molecular TB diagnostic test on stool
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment
Timepoint [1] 0 0
72 hours after enrolment
Secondary outcome [1] 0 0
Eight-week all-cause mortality
Timepoint [1] 0 0
8 weeks after enrolment
Secondary outcome [2] 0 0
The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.
Timepoint [2] 0 0
72 hours after enrolment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
Accrual to date
Final
1172
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Mozambique
State/province [1] 0 0
Vila Da Manhiça
Country [2] 0 0
Mozambique
State/province [2] 0 0
Maputo
Country [3] 0 0
Tanzania
State/province [3] 0 0
Bagamoyo
Country [4] 0 0
Tanzania
State/province [4] 0 0
Mbeya

Funding & Sponsors
Primary sponsor type
Other
Name
Foundation for Innovative New Diagnostics, Switzerland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ludwig-Maximilians - University of Munich
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Instituto Nacional de Saúde, Mozambique
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Centro de Investigação em Saúde de Manhiça
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
National Institute for Medical Research, Tanzania
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Ifakara Health Institute
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Ospedale San Raffaele
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Swiss Tropical & Public Health Institute
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
African Society for Laboratory Medicine
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Heidelberg University
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Barcelona Institute for Global Health
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alberto García-Basteiro, MD
Address 0 0
Barcelona Institute for Global Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
After publication of the primary peer-reviewed manuscript
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04568967