NCT03684759

Brief Summary

The aim of this pilot study is to demonstrate the feasibility of viral biomolecular diagnosis in sputum compared to nasopharyngeal swab in cystic fibrosis acute respiratory infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

September 21, 2018

Last Update Submit

September 24, 2018

Conditions

Cystic FibrosisRespiratory Infection

Keywords

ExpectorationCystic FibrosisNasopharyngealViral molecular diagnosis

Outcome Measures

Primary Outcomes (1)

  • Concordance of viral type detected in both samples for each participant: sputum and nasopharyngeal swab

    Comparison of per participant results of viral molecular detection in sputum and nasopharyngeal swab. Concordance=same virus(es) or no virus detected in both sample. no concordance=different viruses detected in each sample or virus(es) detected in only one sample and not in the other

    Day 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participant living with cystic fibrosis disease cared in french pediatric or adult CRCM

You may qualify if:

  • Participant with Cystic Fibrosis
  • Participant able to expectorate
  • Participant with sign of acute respiratory infection

You may not qualify if:

  • participant not able to expectorate
  • patient refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU d'Angers

Angers, 49933, France

Location

Centre de Perharidy

Roscoff, 29684, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

respiratory samples were retained at -80°C

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract Infections

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesInfections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 26, 2018

Study Start

February 24, 2016

Primary Completion

February 6, 2017

Study Completion

February 6, 2017

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

FR(3)