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AzTrials

TuberculosisNCT04568967

TB-CAPT EXULTANT - HIV

A study testing Concentrated urine with Xpert Ultra and Stool with Xpert Ultra in people with Tuberculosis and HIV Coinfection, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis, HIV Coinfection, Diagnoses Disease
What is being tested?
Concentrated urine with Xpert Ultra and Stool with Xpert Ultra
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,172 participants
Where
4 sitesin 2 countries
Study dates
5 Sep 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Mozambique2 sites

  • Centro de Investigação em Saúde de Manhiça-Fundação

    Manhiça, Vila Da Manhiça, 1929

  • Instituto Nacional de Saúde (INS)

    Maputo, 1100

Other trials in Mozambique

Tanzania2 sites

  • Ifakara Health Institute (IHI)

    Bagamoyo, 53502

  • National Institute of Medical Research (NIMR)

    Mbeya, 2410

Other trials in Tanzania

About this study

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

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.

Read the 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.
Being tested
Concentrated urine with Xpert Ultra, Stool with Xpert Ultra
Medical subject headings
Tuberculosis, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Concentrated urine with Xpert UltraDiagnostic test

    Molecular TB diagnostic test on urine

  • Stool with Xpert UltraDiagnostic test

    Molecular TB diagnostic test on stool

Study groups in NCT04568967
Study groupRoleWhat they receive
intervention armExperimentalThe 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.
Receives: Diagnostic Test: Concentrated urine with Xpert Ultra; Diagnostic Test: Stool with Xpert Ultra
control armNo interventionThe 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 .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 72 hours after enrolment

Secondary outcomes (2)

  1. 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.

    Measured: 8 weeks after enrolment

  2. 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.

    Measured: 72 hours after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start5 Sep 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568967
Sponsor's protocol ID
TB043-3/1
Status last verified
Apr 2025
First submitted
23 Sep 2020
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Cossa M, Ndege R, Meggi B, Mangu C, Leukes V, Sabi I, Khosa C, Kivuma B, Nguenha D, Riess F, Fernandez-Escobar C, de la Torre-Perez L, Manjate P, Weisser M, Machiana A, Zachariah C, Tagliani E, Ehrlich J, Buech J, Schacht C, Sanz S, Singh S, Mnzava D, Schumacher SG, Cox H, Scott L, Ntinginya N, Kranzer K, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. Expanding Xpert MTB/RIF Ultra and lateral flow urine lipoarabinomannan testing for diagnosis of tuberculosis among adults living with HIV admitted to hospitals in Tanzania and Mozambique (EXULTANT): a randomised controlled trial. Lancet Infect Dis. 2026 May 6:S1473-3099(26)00133-7. doi: 10.1016/S1473-3099(26)00133-7. Online ahead of print.

    PubMed 42105779

  • Mangu C, Cossa M, Ndege R, Khosa C, Leukes V, de la Torre-Perez L, Machiana A, Kivuma B, Mnzava D, Zachariah C, Manjate P, Tagliani E, Schacht C, Buech J, Singh S, Ehrlich J, Riess F, Sanz S, Kranzer K, Cox H, Sabi I, Nguenha D, Meggi B, Weisser M, Ntinginya N, Schumacher S, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. Expanding Xpert MTB/RIF Ultra(R) and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial). BMC Infect Dis. 2024 Aug 15;24(1):831. doi: 10.1186/s12879-024-09651-z.

    PubMed 39148008

Questions about this trial

What is this clinical trial studying?

A study testing Concentrated urine with Xpert Ultra and Stool with Xpert Ultra in people with Tuberculosis and HIV Coinfection, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mozambique, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment (time frame: 72 hours after enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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