Molecular Diagnosis of Respiratory Viral Infections on Sputum From Cystic Fibrosis Patients (MUCOVIR)
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| ClinicalTrials.gov Identifier: NCT03736096 |
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Recruitment Status :
Completed
First Posted : November 8, 2018
Last Update Posted : January 18, 2023
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| Condition or disease |
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| Cystic Fibrosis Acute Respiratory Infection |
Viral respiratory infections in cystic fibrosis (CF) have a significant impact on the progression of the disease. It is therefore essential to look for these viruses. No recommendations are made for the virological follow-up of CF patients and no optimal strategy for the type of sampling required. In non-CF patients, the search for a viral infection is performed by nasopharyngeal sampling. This method of sampling is invasive and uncomfortable for the patient. In CF patients, sputum, non-invasive sampling, is routinely used for bacterial research and may be used for viral infections to avoid invasive nasopharyngeal sampling in patients whose management is heavy.
After giving consent, both sputum and nasopharyngeal swab are collected for each participant. A record of clinical and biological data is also made at inclusion. A molecular viral search is performed on both samples by a multiplex technique detecting a broad spectrum of respiratory viruses. A bacteriological analysis is carried out on sputum. The molecular results will be interpreted blindly according to the main criterion of evaluation, presence or absence of viral infection.
Comparison of expectoration to nasopharyngeal sampling of CF patients for respiratory virological diagnosis should analyse agreement of the molecular viral detection and position CF sputum as an optimal assay for respiratory viruses with the advantage of not being invasive and in all cases routinely taken for the control and bacterial follow-up.
The promotion of sputum as an ad hoc sampling for viral research and epidemiology would facilitate the establishment of surveillance for viral infections in cystic fibrosis and thereby contribute to the CF register data.
| Study Type : | Observational |
| Actual Enrollment : | 115 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis |
| Actual Study Start Date : | October 3, 2018 |
| Actual Primary Completion Date : | June 24, 2021 |
| Actual Study Completion Date : | June 24, 2021 |
- Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab [ Time Frame: Day 1 ]Comparison of per participant results of viral molecular detection in both sputum and nasapharyngeal samples: 18 different types of respiratory viruses may be qualitatively detected by Molecular analyses (multiplex PCR) the Outcome Measure results will be reported as number of participants with same virus type in both sample - number participant with different virus detected in the two samples - number of participants with no virus detected in both samples - number of participants with one virus detected in nasapharyngeal and no virus in sputum - number of participant with no virus detected in nasopharyngeal and one virus detected in sputum - and so on for every possible combinations
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- participant with Cystic Fibrosis
- participant with sign of acute respiratory infection
- participant able to expectorate
Exclusion Criteria:
- participant not able to expectorate
- participant refusing to participate
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): NCT03736096
| France | |
| CHU d'ANGERS | |
| Angers, France, 49033 | |
| CHU de CAEN | |
| Caen, France, 14700 | |
| CHU de NANTES | |
| Nantes, France, 44000 | |
| AP-HP - Hôpital TROUSSEAU | |
| Paris, France, 75012 | |
| CHRU de Rennes | |
| Rennes, France, 35033 Cedex 09 | |
| Centre de PERHARIDY | |
| Roscoff, France, 29684 | |
| Hôpital FOCH | |
| Suresnes, France, 92151 | |
| CHU Toulouse CRCM Pediatrique | |
| Toulouse, France, 31059 Cedex 9 | |
| CHU Toulouse CRCM Adulte | |
| Toulouse, France, 31059 | |
| CHU Tours | |
| Tours, France, 37000 | |
| CHU de Tours | |
| Tours, France, 37044 | |
| Principal Investigator: | Sophie VALLET, MD | CHU Brest |
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT03736096 |
| Other Study ID Numbers: |
MUCOVIR (2017-A02380-53) |
| First Posted: | November 8, 2018 Key Record Dates |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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cystic fibrosis sputum nasopharyngeal swab |
viral molecular diagnosis respiratory infection expectoration |
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Cystic Fibrosis Fibrosis Infections Communicable Diseases Respiratory Tract Infections Virus Diseases Disease Attributes |
Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |