ICU Yeast Intra-abdominal InfectionPhase 3CASPERNCT03580733
Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
A Phase 3 study testing caspofungin antifungal therapy in people with ICU Yeast Intra-abdominal Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Yeast Intra-abdominal Infection
- What is being tested?
- caspofungin antifungal therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 4 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)
- Infected acute pancreatitis
- Ascites fluid infection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens
Herve Dupont, 33 322 087 979, dupont.herve@chu-amiens.fr
About this study
Official title: Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
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.
Read the 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.
- Conditions
- ICU Yeast Intra-abdominal Infection
- Being tested
- caspofungin antifungal therapy, placebo
- Keywords
- ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofungin antifungal therapyDrug
caspofungin
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Other: placebo |
| antifungal therapy | Experimental | caspofungin Receives: Drug: caspofungin antifungal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure rate after the beginning of treatment
28-day failure rate after the beginning of treatment
Measured: 28 days
Secondary outcomes (4)
mortality
28 and 90-day mortality rate
Measured: 28 and 90 days
success rate at the end of treatment
success rate at the end of treatment
Measured: 8 days
slope of ß-D-glucan concentrations
slope of ß-D-glucan concentrations
Measured: 8 days
mortality
28- 28 day mortality for subgroup analysis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Jan 2019
- Primary completion4 Oct 2024 (estimated)
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Yeast Intra-abdominal InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580733
- Sponsor's protocol ID
- PI2018_843_0007
- Acronym
- CASPER
- Status last verified
- Jul 2024
- First submitted
- 8 Jun 2018
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
- ClinicalTrials.gov ID
- NCT03580733
- Acronym / sponsor ID
- CASPER / PI2018_843_0007
- Conditions
- ICU Yeast Intra-abdominal Infection
- Keywords
- ICU, yeast intra abdominal infection, candidiasis, ß-D-glucan, caspofungin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 4 Oct 2024 (estimated)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placeboplacebo |
| antifungal therapy | Experimental | Drug: caspofungin antifungal therapycaspofungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Covered by national health insurance
- Admitted to ICU after surgery for intra-abdominal infection :
- With written and signed informed consent
Key exclusion criteria (9 listed)
- Allergy to caspofungin
- Life expectancy ≤ 48h
- Expected withdrawal of treatment
- Radiological drainage without surgery
- Severe hepatic impairment (Child-Pugh C score)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caspofungin antifungal therapycaspofungin | Drug | antifungal therapy |
| placeboplacebo | Other | placebo |
Primary outcome
failure rate after the beginning of treatment
Time frame: 28 days
28-day failure rate after the beginning of treatment
4 secondary outcomes
mortality
Time frame: 28 and 90 days
success rate at the end of treatment
Time frame: 8 days
slope of ß-D-glucan concentrations
Time frame: 8 days
mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing caspofungin antifungal therapy in people with ICU Yeast Intra-abdominal Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé Dupont, PD (33 322 087 979, dupont.herve@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure rate after the beginning of treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.