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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2015
Main ID:	NCT02573623
Date of registration:	22/09/2015
Prospective Registration:	No
Primary sponsor:	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title:	Evaluation of an Innovative Tuberculosis Diagnostic Test PROMISE-TB
Scientific title:	Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Date of first enrolment:	July 2013
Target sample size:	300
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02573623
Study type:	Observational
Study design:	Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
Zambia

Contacts

Name:	Chipepo Kankasa, MD, PhD
Address:
Telephone:
Email:
Affiliation:	University of Zambia, Zambia

Name:	Philippe Van de Perre, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Université de Montpellier, France

Name:	Edouard Tuaillon, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Université de Montpellier, France

Name:	Mwiya Miwya, MD
Address:
Telephone:	+260 211 257535
Email:	mwiya2002@yahoo.com
Affiliation:

Name:	Nicolas Nagot, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Université de Montpellier, France

Name:	Chipepo Kandasa, MD, PhD
Address:
Telephone:	+260 211 251662
Email:	ckankasa@zamnet.zm
Affiliation:

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: 15 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV

Tuberculosis

Intervention(s)

Primary Outcome(s)

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]

Secondary Outcome(s)

Secondary ID(s)

ANRS12293 PROMISE-TB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European and Developing Countries Clinical Trials Partnership (EDCTP)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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