NCT06969703

Brief Summary

The China Antifungal Resistance Surveillance Trial (CARST-fungi) study, which has been starting in July 2019, is a multi-center, prospective, observational, and laboratory-based study of pathogenic fungal isolates causing IFDs. All fungal isolates recovered from clinical samples will be collected. For each episode of fungal isolation, the information including the patient's age, gender, the ward location, the time of sample collection, and specimen type will be collected. All isolates will be sent to the Research Center for Medical Mycology, Beijing, China, for further study including species identification and azole susceptibility testing. Azole-resistant mechanisms will be elucidated by gene sequencing or expression level assay for resistance-related genes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

April 28, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

June 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 14, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

April 28, 2025

Last Update Submit

May 12, 2025

Conditions

Keywords

Azole susceptibilitypathogenic fungiresistance mechanismsResistance Surveillance

Outcome Measures

Primary Outcomes (1)

  • The type and spectrum of azole-resistance in the pathogenic fungi

    By the end of Dec. 2025

Eligibility Criteria

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

The individuals with fungal disease

You may qualify if:

  • fungal disease

You may not qualify if:

  • non-fungal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (2)

  • Bassetti M, Garnacho-Montero J, Calandra T, Kullberg B, Dimopoulos G, Azoulay E, Chakrabarti A, Kett D, Leon C, Ostrosky-Zeichner L, Sanguinetti M, Timsit JF, Richardson MD, Shorr A, Cornely OA. Intensive care medicine research agenda on invasive fungal infection in critically ill patients. Intensive Care Med. 2017 Sep;43(9):1225-1238. doi: 10.1007/s00134-017-4731-2. Epub 2017 Mar 2.

    PMID: 28255613BACKGROUND
  • Pfaller MA, Woosley LN, Messer SA, Jones RN, Castanheira M. Significance of molecular identification and antifungal susceptibility of clinically significant yeasts and moulds in a global antifungal surveillance programme. Mycopathologia. 2012 Oct;174(4):259-71. doi: 10.1007/s11046-012-9551-x. Epub 2012 May 13.

    PMID: 22580756BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the fungal isolates from the sterile sites, including blood, ascitic fluid, pleural fluid, cerebrospinal fluid, and pus, bronchoalveolar lavage fluid (BALF), central venous catheter (CVC) tips, biliary tract fluid and tissues of patients with invasive yeast infections.

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Wei Liu

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu, M.D., Ph.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 14, 2025

Study Start

June 10, 2025

Primary Completion

September 15, 2025

Study Completion

September 30, 2025

Last Updated

May 14, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

I will share the information of all the fungal isolates. But, I am not sure if I will be able to share the fungal isolates.

Shared Documents
STUDY PROTOCOL, SAP

Locations