TuberculosisPROMISE-TBNCT02573623
Evaluation of an Innovative Tuberculosis Diagnostic Test
An observational study of Tuberculosis and HIV, run by ANRS, Emerging Infectious Diseases at 1 site in Zambia.
Trial summary
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, HIV
- How many people
- 300 participants
- Where
- 1 siteZambia
- Study dates
- Jul 2013to Dec 2015
- Phase
- Observational
- 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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 0 to 15 years with a definite diagnosis of tuberculosis infection, HIV-infected or uninfected. They will be matched on age and HIV status, to an equivalent number of children without any evidence of tuberculosis infection.
Who may be able to join
- one of 4 clinical signs
- persistent and unexplained cough
- unexplained weight loss or failure to thrive
- persistent and unexplained fever
- persistent and unexplained lethargy or reduced playfulness
- chest X-Ray consistent with a tuberculosis infection
- an adenitis compatible with non-pulmonary tuberculosis Among these children only those with confirmed TB will be analysed for the primary outcome
- children without any of the signs and symptoms quoted above
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Zambia1 site, 1 recruiting
- Recruiting
Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
Lusaka
Mwiya Miwya, MD, +260 211 257535, mwiya2002@yahoo.com
About this study
Official title: Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools.
This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
Read the detailed description
The study is designed as a prospective study for the evaluation of diagnostic tests.
Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture.
In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status.
In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation.
The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.
- Conditions
- Tuberculosis, HIV
- Keywords
- Immunology diagnosis test, Children, Zambia
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected children with confirmed TB | Hospitalized children with TB confirmed by culture or GeneXpert | |
| HIV-uninfected children aged<5 years with confirmed TB | Hospitalized children aged<5 years with TB confirmed by culture or GeneXpert | |
| HIV-uninfected children aged>4 years with confirmed TB | Hospitalized children aged>4 years with TB confirmed by culture or GeneXpert | |
| HIV-infected control children | Children hospitalized in the surgery ward without any evidence of tuberculosis infection | |
| HIV-uninfected controls aged <5 years | Children <5 years hospitalized in the surgery ward without any evidence of tuberculosis infection | |
| HIV-uninfected controls aged >4 years | Children >4 years hospitalized in the surgery ward without any evidence of tuberculosis infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
Measured: baseline
Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startJul 2013
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Edouard Tuaillon, MD, PhD, Study director, Université de Montpellier, FranceChipepo Kankasa, MD, PhD, Study director, University of Zambia, ZambiaPhilippe Van de Perre, MD, PhD, Study chair, Université de Montpellier, FranceNicolas Nagot, MD, PhD, Principal investigator, Université de Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573623
- Sponsor's protocol ID
- ANRS12293 PROMISE-TB
- Acronym
- PROMISE-TB
- Status last verified
- Oct 2015
- First submitted
- 22 Sep 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
- ClinicalTrials.gov ID
- NCT02573623
- Acronym / sponsor ID
- PROMISE-TB / ANRS12293 PROMISE-TB
- Conditions
- Tuberculosis, HIV
- Keywords
- Immunology diagnosis test, Children, Zambia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- Jul 2013
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools.
This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
Detailed description
The study is designed as a prospective study for the evaluation of diagnostic tests.
Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture.
In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status.
In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation.
The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.
Study design
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HIV-infected children with confirmed TB | – | –Hospitalized children with TB confirmed by culture or GeneXpert |
| HIV-uninfected children aged<5 years with confirmed TB | – | –Hospitalized children aged<5 years with TB confirmed by culture or GeneXpert |
| HIV-uninfected children aged>4 years with confirmed TB | – | –Hospitalized children aged>4 years with TB confirmed by culture or GeneXpert |
| HIV-infected control children | – | –Children hospitalized in the surgery ward without any evidence of tuberculosis infection |
| HIV-uninfected controls aged <5 years | – | –Children <5 years hospitalized in the surgery ward without any evidence of tuberculosis infection |
| HIV-uninfected controls aged >4 years | – | –Children >4 years hospitalized in the surgery ward without any evidence of tuberculosis infection |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 0 to 15 years with a definite diagnosis of tuberculosis infection, HIV-infected or uninfected. They will be matched on age and HIV status, to an equivalent number of children without any evidence of tuberculosis infection.
Key inclusion criteria (8 listed)
- one of 4 clinical signs
- chest X-Ray consistent with a tuberculosis infection
- an adenitis compatible with non-pulmonary tuberculosis Among these children only those with confirmed TB will be analysed for the primary outcome
- children without any of the signs and symptoms quoted above
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
Time frame: baseline
Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edouard Tuaillon, MD, PhD study director
Université de Montpellier, France
Chipepo Kankasa, MD, PhD study director
University of Zambia, Zambia
Philippe Van de Perre, MD, PhD study chair
Université de Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and HIV, run by ANRS, Emerging Infectious Diseases at 1 site in Zambia.
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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chipepo Kandasa, MD, PhD (+260 211 251662, ckankasa@zamnet.zm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2015.