NCT03443336

Brief Summary

Prospective multi-center surveillance study on the prevalence of azole-resistant Aspergillus spp. in clinical isolates of patients with pulmonary colonization or invasive infections in Switzerland

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

June 3, 2021

Status Verified

June 1, 2021

Enrollment Period

2.1 years

First QC Date

February 9, 2018

Last Update Submit

June 2, 2021

Conditions

Pulmonary Aspergillosis

Outcome Measures

Primary Outcomes (1)

  • Azole-resistance in Aspergillus (A.) fumigatus

    Distribution of antifungal susceptibility profile of all tracheal and urinary samples in clinical Aspergillus isolates

    start of study until end of study (July 2017 until December 2018)

Eligibility Criteria

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

All patients with a respiratory sample growing Aspergillus spp., will be included

You may qualify if:

  • Available respiratory sample growing Aspergillus spp.
  • Available clinical data

You may not qualify if:

  • refusal to sign the general consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Infectious Diseases and Hospital Epidemiology

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

clinical Aspergillus spp. isolates

MeSH Terms

Conditions

Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

AspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nina Khanna, Prof MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 23, 2018

Study Start

June 1, 2017

Primary Completion

June 30, 2019

Study Completion

June 2, 2021

Last Updated

June 3, 2021

Record last verified: 2021-06

Locations

CH(1)