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

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ClinicalTrials.gov Identifier: NCT03137875
Recruitment Status : Completed
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Epicentre

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.


Condition or disease
Tuberculosis Multi Drug Resistant Tuberculosis

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.


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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Study Start Date : March 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort
Patient with sputum smear positive 2+
patient who will have a positive diagnostic of tuberculosis using microscopy with a 2+ grade
patient smear positive scanty or 1+
patient who will have a positive diagnostic of tuberculosis using microscopy with a scanty or 1+ grade
patient smear negative
patient with a negative TB microscopy result



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study will take place in the Mbarara Regional Referral Hospital (MRRH) located in Mbarara Municipality, Mbarara District, and south-west of Uganda.

Patients suspected of TB are evaluated in the outpatient facility at the hospital or in the medical ward when admitted.

Some samples will be collected from The Aid Support Organisation (TASO) Mbarara. TASO is located in the neighbourhood of MRRH and EMRB.

Criteria

Inclusion Criteria:

  • TB suspect with cough more than 2 weeks

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137875


Locations
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Uganda
Epicentre Mbarara Research Base
Mbarara, Uganda
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres, Netherlands
Investigators
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Study Director: Yap JB Boum II, PhD Epicentre Mbarara

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Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT03137875     History of Changes
Other Study ID Numbers: HS 918
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Epicentre:
Tuberculosis
TB
MDR-TB
LIPA
filter paper
slides
MTBDR Plus

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections