- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04055584
PCR Techniques of Dried Sputum Using a Spotcard
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Groningen, Netherlands
- Recruiting
- University Medical Center Groningen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCR techniques of dried sputum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tuberculosis, Pulmonary
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
Tjip van der WerfGadjah Mada University; The Enose Company, Zutphen the NetherlandsCompletedPulmonary Tuberculosis Suspected | Other Specified Chronic Obstructive Pulmonary Disease | Pulmonary Tuberculosis TB (+) Histology, (-) BacteriologyIndonesia
-
Research Institute of Epidemiology, Microbiology...Active, not recruitingAspergillosis | Pulmonary Tuberculoses | Old Tuberculosis | Active Tuberculosis | Chronic Pulmonary AspergillosisUzbekistan
-
Medecins Sans Frontieres, NetherlandsLondon School of Hygiene and Tropical Medicine; University of Liverpool; Ministry... and other collaboratorsRecruitingMulti-drug Resistant Tuberculosis | Pulmonary Tuberculoses | Extensively Drug-Resistant TuberculosisBelarus, South Africa, Uzbekistan
-
Radboud University Medical CenterEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Department... and other collaboratorsCompletedPulmonary Tuberculosis (TB)South Africa
-
National Institute of Allergy and Infectious Diseases...International Tuberculosis Research CenterWithdrawnRefractory Pulmonary TuberculosisKorea, Republic of
-
Assiut UniversityUnknownExtra Pulmonary Tuberculosis
-
Karolinska InstitutetAddis Ababa University; Armauer Hansen Research Institute, EthiopiaCompleted
-
Michael HoelscherRadboud University Medical Center; German Federal Ministry of Education and... and other collaboratorsCompletedPulmonary Tuberculoses | Other Specified Pulmonary TuberculosisSouth Africa
Clinical Trials on Sputum
-
University of Cape TownCompleted
-
Institut Pasteur de MadagascarJohns Hopkins Bloomberg School of Public Health; National Tuberculosis Program... and other collaboratorsCompleted
-
University of MiamiUniversity of FloridaCompletedCystic Fibrosis | PediatricsUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNCompleted
-
University Hospital, MontpellierActive, not recruiting
-
Imperial College LondonAstraZenecaTerminated
-
Johns Hopkins UniversityUniversity of Witwatersrand, South AfricaCompleted
-
Imperial College LondonCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
University Hospital, BordeauxUnknownChronic Obstructive Pulmonary DiseaseFrance
-
Philipps University Marburg Medical CenterWithdrawn