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

NCT03137875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2017-05-03

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER
  • Epicentre

    lead OTHER

Principal Investigators

  • Yap JB Boum II, PhD · Epicentre Mbarara

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Uganda

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137875 on ClinicalTrials.gov