Evaluation of an Innovative Tuberculosis Diagnostic Test

NCT02573623 | Unknown

• 1 other identifier: ANRS12293 PROMISE-TB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; HIV

Keywords

Immunology diagnosis test; Children; Zambia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (6)

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

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (1)

Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM

Lusaka, Zambia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine Serum Cell culture supernatant

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• 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

  Université de Montpellier, France

  STUDY CHAIR

• Nicolas Nagot, MD, PhD

  Université de Montpellier, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chipepo Kandasa, MD, PhD

CONTACT

+260 211 251662; ckankasa@zamnet.zm

Mwiya Miwya, MD

CONTACT

+260 211 257535; mwiya2002@yahoo.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 12, 2015
• Study Start: July 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

ZA (1)