Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis

Tuberculosis Clinical Trial

Official title:

Evaluation of the PCR Using DNA Extracts From Stained Slides and Sputum Collected on Filter Paper for Identification and Detection of Tuberculosis and Multidrug Resistant (MDR) Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137875
• Other study ID #: HS 918
• Status: Completed
• Phase: N/A
• First received: February 22, 2011
• Last updated: April 28, 2017
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2017
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays. Thus a system that allows specimen to be collected and shipped in a safely manner while reducing the possibilities of contamination, the cost of shipment and especially the time for detection of MDR-TB by using molecular methods would be very useful. Whereas the some studies show promising results for the development and standardization of simple specimen collection and transportation methods for molecular DST, more data is needed before these can be used in routine.

The study described here aims at identifying a suitable method, in terms of adapted sample support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or several methods are found to give satisfying results, then a larger patient based evaluation of this (these) method(s) for molecular DST will be performed in a second phase. The protocol for the second phase will be prepared separately.

Description:

The main objective of this study is to evaluate the performance of PCR in identification and detection of tuberculosis using DNA extracts from stained slides (Ziehl Neelsen and Fluorescence) and Filter paper (FTA card and Genocard).

The secondary objectives of this study are to assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA), to determine the amount of sample required to make a detectable PCR reaction and to assess the feasibility of storage and extraction methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• TB suspect with cough more than 2 weeks

Exclusion Criteria:

Related Conditions & MeSH terms

• Multi Drug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Locations

Country	Name	City	State
Uganda	Epicentre Mbarara Research Base	Mbarara

Sponsors (2)

Lead Sponsor	Collaborator
Epicentre	Medecins Sans Frontieres, Netherlands

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of positive samples for Mycobacterium tuberculosis detected by PCR from slides and filter papers among samples by microscopy	Tests	6 MONTHS
Secondary	To assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA)	Tests	6 MONTHS