PCR Techniques of Dried Sputum Using a Spotcard

April 30, 2021 updated by: Onno Akkerman, University Medical Center Groningen

Molecular testing for mutations in M. tuberculosis genes associated to resistance of anti tuberculosis (TB) drugs is already part of standard laboratory TB diagnostic.

This implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment related toxicity.

The molecular laboratory diagnostics is widely spread in high income, low TB endemic countries. However, the low income countries lack widespread facilities to test for susceptibility, either genotypic or phenotypic. Performing molecular diagnostics on sputum collected with a spot card could improve accessibility to molecular testing.

This study examines if sputum collected and put on spot cards could be used for multiple molecular tests for the detection, identification and susceptibility prediction of TB. This means that DNA extraction of the sputum from the spot card should be feasible.

The study is a pilot study with adult patients of the tuberculosis department of University Medical Centre Groningen (UMCG) Beatrixoord, Haren as subjects. The sputum produced will be collected, dried on spot cards, and DNA extraction from the card will be tested. If molecular detection is positive for the tuberculosis bacteria additional tests will be performed. Based on the present/absent of mutations in the genes associated to resistance susceptibility can be preditec, different molecular techniques will be performed to identify possible mutations. Furthermore, sputum will be collected as patients produce so. Sputum samples with low bacterial load can be tested as well and can test the sensitivity of the procedure.

Lastly, techniques like RNA detection will be tested to identify the bacterial load. This can be done if more than one sample of patients were collected.

Subjects will be selected on age, participation in standard TDM and drug use. Demographic parameters will be analysed. Sputum samples will be taken twice a week (on Tuesday and Friday).

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Groningen, Netherlands
        • Recruiting
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with pulmonary tuberculosis producing sputum

Description

Inclusion Criteria:

  • Patients is 18 years or older
  • Pulmonary TB confirmed by culture or molecular test
  • Producing sputum
  • Signed informed consent

Exclusion Criteria:

  • Extrapulmonary TB
  • Pulmonary TB without production of sputum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sputum spot
DNA extraction and perform a diversity of molecular diagnostic tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
Time Frame: 6 months
Is it possible to perform a diversity of molecular diagnostic TB tests and in addition new next generation sequencing approaches, with the DNA from the dried sputum spots?
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Can we use DNA detection of the sputum from the dried card to certify that in the final utilisation format both the sputum and blood (not collected or tested in this study) are from the same patient?
Time Frame: 6 months
Can we use DNA detection of the sputum from the dried card to certify that in the final utilisation format both the sputum and blood (not collected or tested in this study) are from the same patient?
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 2, 2019

Primary Completion (ANTICIPATED)

November 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (ACTUAL)

August 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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