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| Name | Class |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition | baseline | |
| Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis | baseline |
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Inclusion Criteria for tuberculosis cases:
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
Inclusion Criteria for controls:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chipepo Kandasa, MD, PhD | Contact | +260 211 251662 | ckankasa@zamnet.zm | |
| Mwiya Miwya, MD | Contact | +260 211 257535 | mwiya2002@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Edouard Tuaillon, MD, PhD | Université de Montpellier, France | Study Director |
| Chipepo Kankasa, MD, PhD | University of Zambia, Zambia | Study Director |
| Philippe Van de Perre, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM | Recruiting | Lusaka | Zambia |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Urine Serum Cell culture supernatant
| Université de Montpellier, France |
| Study Chair |
| Nicolas Nagot, MD, PhD | Université de Montpellier, France | Principal Investigator |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |