Candidal PeritonitisPhase 4NCT06985758
Pharmacokinetic Study of Rezafungin in Patients With Suspected Intra-Abdominal Candidiasis
A Phase 4 study testing Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg in people with Candidal Peritonitis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 3 sites in Spain.
Trial summary
Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidal Peritonitis
- What is being tested?
- Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesSpain
- Study dates
- 7 Jan 2026to 13 Jun 2026
- Phase
- Phase 4
- 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
- Patients with suspicion, confirmed or not, of candidiasis peritonitis or intra-abdominal infection by Candida spp. who, after having received information about the design, the purpose of the study, the possible risks that may arise from it and that they can refuse to collaborate at any time, give written consent to participate in the study.
- Be over 18 years of age
- Understand the purpose of the study and be available to perform the visits and procedures established in the protocol
- In women: negative urine pregnancy test performed in the 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed after menopause
- Patients with signs of peritonitis or intra-abdominal infection showing refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
- Patients with abdominal or peritoneal drainage with permeable debit that allows obtaining peritoneal samples through it.
Who cannot join
- Patients in whom there is any contraindication for use according to the established in the technical data sheet or known hypersensitivity to rezafungin or who, according to the investigator's criteria, it is not advisable to participate.
- Patients who do not present suspicion of intra-abdominal candidiasis infection or who are receiving antifungal treatment for another reason.
- Patients receiving another antifungal drug during rezafungin administration.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
About this study
Official title: Phase IV, Open-label, Single Arm, Multicenter Trial to Evaluate Pharmacokinetic Parameters of Peritoneal Diffusion and Peritoneal Diffusion Activity.
Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level.
Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.
Read the detailed description
Intra-abdominal candidiasis is the most common candidal infection after candididaemia. Studies that have positioned echinocandins as the first therapeutic option in candidiasis have been conducted primarily in patients with candidaemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level relative to isolates at the blood culture level.
Rezafungin has the characteristic of having a modified chemical structure that gives it greater stability and a prolonged half-life, allowing the drug to be administered less frequently on a weekly rather than daily basis. This results in greater clearance of candidemia and greater penetration and persistence in tissues compared to other echinocandins, and improves patient adherence to treatment.
The efficacy of Rezafungin has already been evaluated in clinical trials, and has been shown to be equal or superior to that of other echinocandins, and because it has a low incidence of cross-resistance with other antifungals, it is an appropriate choice for resistant fungal infections.
- Conditions
- Candidal Peritonitis
- Being tested
- Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mgDrug
Also called Rezafungin
Intravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug.
| Study group | Role | What they receive |
|---|---|---|
| Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg | Experimental | Intravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug. Receives: Drug: Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peack Plasma Concentration (Cmax)
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Measured: 7 days
Minimum Plasma Concentration (Cmin)
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Measured: 7 days
Area Under the Rezafungin Curve levels in blood.
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Measured: 7 days
Death curve analysis
Analysis of peritoneal fluid death curves in the samples per patient obtained
Measured: 7 days
Secondary outcomes (7)
Duration of treatment
Time in days or weeks that the treatment lasts for each patient
Measured: 8 weeks
Overall mortality
Mortality, related or not to the treatment
Measured: 8 weeks
Atributable mortality
Mortality related to the treatment
Measured: 8 weeks
Blood tests
Data obtained from the performance of blood tests
Measured: 8 weeks
Intra-abdominal cultures
Data obtained from intra-abdominal cultures
Measured: 8 weeks
Radiology tests
Data obtained from radiology tests
Measured: 8 weeks
Analytical tests
Data obtained from analytical tests
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start7 Jan 2026
- Primary completion31 May 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidal PeritonitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesús Fortún Abete, MD, Principal investigator, IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985758
- Sponsor's protocol ID
- REZAPACQ
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Open-label, Single Arm, Multicenter Trial to Evaluate Pharmacokinetic Parameters of Peritoneal Diffusion and Peritoneal Diffusion Activity.
- ClinicalTrials.gov ID
- NCT06985758
- Acronym / sponsor ID
- REZAPACQ
- Conditions
- Candidal Peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 22 May 2025 (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.
Intra-abdominal candidiasis is the most frequent candidiasis infection after candidemia. The studies that have positioned echinocandins as the first therapeutic option in candidiasis have been carried out mainly in patients with candidemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level in relation to isolates at the blood culture level.
Rezafungin, with its special pharmacokinetics, achieves higher tissue concentrations, including hepato-splenic and other abdominal organs, than the other echinocandins. Experimental studies have confirmed that the concentration of rezafungin at the level of the inflammatory focus in abdominal infections is higher than in the surrounding healthy tissue and higher than those achieved by micafungin. Finally, the biofilm activity of rezafungin is very high, clearly superior to fluconazole and possibly higher than that of other echinocandins.
Detailed description
Intra-abdominal candidiasis is the most common candidal infection after candididaemia. Studies that have positioned echinocandins as the first therapeutic option in candidiasis have been conducted primarily in patients with candidaemia. Peritoneal concentrations of caspofungin, micafungin and anidulafungin are clearly above the MICs of most Candida spp but are below the threshold for selection of resistant mutants, which has been argued by some researchers as a risk for the control of intra-abdominal infections with poor control of the focus and selection of resistant mutants, observed in Candida spp isolates at the peritoneal level relative to isolates at the blood culture level.
Rezafungin has the characteristic of having a modified chemical structure that gives it greater stability and a prolonged half-life, allowing the drug to be administered less frequently on a weekly rather than daily basis. This results in greater clearance of candidemia and greater penetration and persistence in tissues compared to other echinocandins, and improves patient adherence to treatment.
The efficacy of Rezafungin has already been evaluated in clinical trials, and has been shown to be equal or superior to that of other echinocandins, and because it has a low incidence of cross-resistance with other antifungals, it is an appropriate choice for resistant fungal infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg | Experimental | Drug: Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mgIntravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with suspicion, confirmed or not, of candidiasis peritonitis or intra-abdominal infection by Candida spp. who, after having received information about the design, the purpose of the study, the possible risks that may arise from it and that they can refuse to collaborate at any time, give written consent to participate in the study.
- Be over 18 years of age
- Understand the purpose of the study and be available to perform the visits and procedures established in the protocol
- In women: negative urine pregnancy test performed in the 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed after menopause
- Patients with signs of peritonitis or intra-abdominal infection showing refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
Key exclusion criteria (3 listed)
- Patients in whom there is any contraindication for use according to the established in the technical data sheet or known hypersensitivity to rezafungin or who, according to the investigator's criteria, it is not advisable to participate.
- Patients who do not present suspicion of intra-abdominal candidiasis infection or who are receiving antifungal treatment for another reason.
- Patients receiving another antifungal drug during rezafungin administration.
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 |
|---|---|---|
| Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mgAlso: RezafunginIntravenous administration of a first dose of Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg to study the pharmacokinetic parameters of the drug. | Drug | Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg |
Primary outcome
Peack Plasma Concentration (Cmax)
Time frame: 7 days
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Minimum Plasma Concentration (Cmin)
Time frame: 7 days
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Area Under the Rezafungin Curve levels in blood.
Time frame: 7 days
Evaluation of the ratio between Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid in relation to Cmax, Cmin and Area Under the Rezafungin Curve levels in blood.
Death curve analysis
Time frame: 7 days
Analysis of peritoneal fluid death curves in the samples per patient obtained
7 secondary outcomes
Duration of treatment
Time frame: 8 weeks
Overall mortality
Time frame: 8 weeks
Atributable mortality
Time frame: 8 weeks
Blood tests
Time frame: 8 weeks
Intra-abdominal cultures
Time frame: 8 weeks
Radiology tests
Time frame: 8 weeks
Analytical tests
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- 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.
Jesús Fortún Abete, MD principal investigator
IRYCIS. Hospital Universitario Ramón y Cajal. Madrid, Spain.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rezafungin 400mg followed by weekly doses of intravenous Rezafungin 200mg in people with Candidal Peritonitis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 3 sites in Spain.
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 3 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peack Plasma Concentration (Cmax) (time frame: 7 days). The study lists 4 primary outcomes in all. 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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.