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

NCT ID: NCT03137875

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-12-31

Brief 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.

Detailed 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.

Conditions

Tuberculosis; Multi Drug Resistant Tuberculosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patient with sputum smear positive 2+

patient who will have a positive diagnostic of tuberculosis using microscopy with a 2+ grade

No interventions assigned to this group

patient smear positive scanty or 1+

patient who will have a positive diagnostic of tuberculosis using microscopy with a scanty or 1+ grade

No interventions assigned to this group

patient smear negative

patient with a negative TB microscopy result

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• TB suspect with cough more than 2 weeks

Exclusion Criteria

• None

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medecins Sans Frontieres, Netherlands

OTHER

Sponsor Role: collaborator

Epicentre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yap JB Boum II, PhD

Role: STUDY_DIRECTOR

Epicentre Mbarara

Locations

Epicentre Mbarara Research Base

Mbarara, , Uganda

Countries

Uganda

Other Identifiers

HS 918

Identifier Type: -

Identifier Source: org_study_id