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Evaluation of an Innovative Tuberculosis Diagnostic Test (PROMISE-TB)

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ClinicalTrials.gov Identifier: NCT02573623
Recruitment Status : Unknown
Verified October 2015 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Recruiting
First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief 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.

This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.


Condition or disease
Tuberculosis HIV

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Study Start Date : July 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition [ Time Frame: baseline ]
  2. Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis [ Time Frame: baseline ]

Biospecimen Retention:   Samples Without DNA
Urine Serum Cell culture supernatant


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria for tuberculosis cases:

  • 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

Inclusion Criteria for controls:

  • children without any of the signs and symptoms quoted above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573623


Contacts
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Contact: Chipepo Kandasa, MD, PhD +260 211 251662 ckankasa@zamnet.zm
Contact: Mwiya Miwya, MD +260 211 257535 mwiya2002@yahoo.com

Locations
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Zambia
Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM Recruiting
Lusaka, Zambia
Contact: Mwiya Miwya, MD    +260 211 257535    mwiya2002@yahoo.com   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
European and Developing Countries Clinical Trials Partnership (EDCTP)
Investigators
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Study Director: Edouard Tuaillon, MD, PhD Université de Montpellier, France
Study Director: Chipepo Kankasa, MD, PhD University of Zambia, Zambia
Study Chair: Philippe Van de Perre, MD, PhD Université de Montpellier, France
Principal Investigator: Nicolas Nagot, MD, PhD Université de Montpellier, France

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02573623     History of Changes
Other Study ID Numbers: ANRS12293 PROMISE-TB
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Immunology diagnosis test
Children
Zambia

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections