Study Comparing Caspofungin to Placebo for the Treatment... | NCT03580733

Studies
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

NCT03580733

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Recruiting

Last Update Posted

Jul 10, 2024Actual

Enrollment

448Estimated

Phase

Phase 3

Conditions

ICU Yeast Intra-abdominal Infection

Interventions

caspofungin antifungal therapy
placebo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Oct 4, 2024Estimated

Completion Date

Dec 4, 2024Estimated

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2024

Last Update Posted Date

Jul 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

Detailed Description

The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. These infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. So far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. No prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. The aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

448Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	placebo	Other: placebo
antifungal therapy	Experimental	caspofungin	Drug: caspofungin antifungal therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
caspofungin antifungal therapy	Drug	caspofungin	antifungal therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
failure rate after the beginning of treatment	28-day failure rate after the beginning of treatment	28 days

Secondary Outcomes

Measure	Description	Time Frame
mortality	28 and 90-day mortality rate	28 and 90 days
success rate at the end of treatment	success rate at the end of treatment	8 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years old
Covered by national health insurance
Admitted to ICU after surgery for intra-abdominal infection :
- With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3(1)
- Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively.
With written and signed informed consent

Exclusion Criteria:

Allergy to caspofungin
Life expectancy ≤ 48h
Expected withdrawal of treatment
Radiological drainage without surgery
Severe hepatic impairment (Child-Pugh C score)
Pregnant or lactating women
Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)
Infected acute pancreatitis
Ascites fluid infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hervé Dupont, PD	Contact	33 322 087 979		dupont.herve@chu-amiens.fr
Hervé Dupont	Contact	33 322 087 979		dupont.herve@chu-amiens.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Amiens	Recruiting	Amiens			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections