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NCT Number: NCT03137875

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

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Multi Drug Resistant Tuberculosis Mycobacterium Infections Tuberculosis, Multidrug-Resistant

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Epicentre Mbarara Research Base

Mbarara, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TB suspect with cough more than 2 weeks

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. proportion of positive samples for Mycobacterium tuberculosis detected by PCR from slides and filter papers among samples by microscopy

    Time frame: 6 MONTHS

    Tests

Secondary outcomes

  1. To assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA)

    Time frame: 6 MONTHS

    Tests

Sponsors and collaborators

Lead sponsor

Epicentre

Other

Collaborators

  • Medecins Sans Frontieres, Netherlands

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 3, 2017
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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