CandidemiaPhase 3NCT01270490
Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
A Phase 3 study testing Interferon-gamma, Recombinant in people with Candidemia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- Interferon-gamma, Recombinant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jan 2013
- 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
- Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
- Subjects who are 18 years of age or older
- Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
- Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:
- Temperature >37.8 ˚C on 2 occasions at least 4 hours apart or one measurement > 38.2 ˚C
- Systolic blood pressure <90 or a >30 mmHg decrease in systolic BP from the subject's normal baseline.
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- Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus)
- Radiologic findings of invasive candidiasis
- Subject or their legal representative must sign a written informed consent form.
Who cannot join
- Subjects with a history of allergy or intolerance to echinocandins or IFNgamma
- Subjects with a history of documented epileptic seizures
- Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)
- Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)
- Subjects with an absolute neutrophil count of less than 500/mm3 at study entry
- Women who are pregnant or lactating
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- Subjects who are unlikely to survive more than 24 hours
- Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied.
- Subjects who have received more than 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Centre Nijmegen
Nijmegen, 6525 GA
Corine Delsing, MD, +31-24-3618819, C.Delsing@aig.umcn.nl
Corine Delsing, MD
About this study
Official title: A Multicentre, Prospective, Randomized Open-label Pilot Study to Assess the Feasibility and Preliminary Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia
- Conditions
- Candidemia
- Being tested
- Interferon-gamma, Recombinant
- Keywords
- candidemia, candida sepsis, invasive fungal disease
- Medical subject headings
- Candidemia, Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-gamma, RecombinantDrug
Interferon 50 mcg/m2 to be administered three times per week during two weeks
| Study group | Role | What they receive |
|---|---|---|
| Interferon-gamma | Experimental | Not described Receives: Drug: Interferon-gamma, Recombinant |
| No intervention | No intervention | No adjunctive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to negative blood cultures
Measured: at fixed time points during follow up (at least until 8 weeks after end of treatment)
Secondary outcomes (7)
overall survival
Measured: until 8 weeks after end of treatment
time to death
Measured: Until 8 weeks after end of treatment
outcome of fungal infection
resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters
Measured: Until 8 weeks after end of treatment
duration of antifungal therapy
Measured: Until end of treatment
duration of hospitalization
Measured: Until end of hospitilization
immunological parameters
Measured: Until 8 weeks after end of treatment
tolerability and safety
Measured: until 8 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Principal investigator, Corine Delsing, Radboud University Medical Center
- Investigators
- Mihai Netea, MD PhD, Study director, Radboud University Medical CenterCorine Delsing, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270490
- Sponsor's protocol ID
- Interferon-gamma 001
- Other IDs
- 2009-014600-66, NL28823.091.10, 2009
- Status last verified
- Feb 2012
- First submitted
- 4 Jan 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Delsing CE, Gresnigt MS, Leentjens J, Preijers F, Frager FA, Kox M, Monneret G, Venet F, Bleeker-Rovers CP, van de Veerdonk FL, Pickkers P, Pachot A, Kullberg BJ, Netea MG. Interferon-gamma as adjunctive immunotherapy for invasive fungal infections: a case series. BMC Infect Dis. 2014 Mar 26;14:166. doi: 10.1186/1471-2334-14-166.
PubMed 24669841
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Randomized Open-label Pilot Study to Assess the Feasibility and Preliminary Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia
- ClinicalTrials.gov ID
- NCT01270490
- Acronym / sponsor ID
- Interferon-gamma 001
- Conditions
- Candidemia
- Keywords
- candidemia, candida sepsis, invasive fungal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- First posted
- 5 Jan 2011 (estimated)
- 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 purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon-gamma | Experimental | Drug: Interferon-gamma, Recombinant |
| No intervention | No intervention | –No adjunctive treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).
- Subjects who are 18 years of age or older
- Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
- Subjects who have clinical evidence of infection AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:
- Subject or their legal representative must sign a written informed consent form.
Key exclusion criteria (9 listed)
- Subjects with a history of allergy or intolerance to echinocandins or IFNgamma
- Subjects with a history of documented epileptic seizures
- Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)
- Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)
- Subjects with an absolute neutrophil count of less than 500/mm3 at study entry
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 |
|---|---|---|
| Interferon-gamma, RecombinantInterferon 50 mcg/m2 to be administered three times per week during two weeks | Drug | Interferon-gamma |
Primary outcome
the time to negative blood cultures
Time frame: at fixed time points during follow up (at least until 8 weeks after end of treatment)
7 secondary outcomes
overall survival
Time frame: until 8 weeks after end of treatment
time to death
Time frame: Until 8 weeks after end of treatment
outcome of fungal infection
Time frame: Until 8 weeks after end of treatment
duration of antifungal therapy
Time frame: Until end of treatment
duration of hospitalization
Time frame: Until end of hospitilization
immunological parameters
Time frame: Until 8 weeks after end of treatment
tolerability and safety
Time frame: until 8 weeks after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Derived from this study: PubMed 24669841Delsing CE, Gresnigt MS, Leentjens J, Preijers F, Frager FA, Kox M, Monneret G, Venet F, Bleeker-Rovers CP, van de Veerdonk FL, Pickkers P, Pachot A, Kullberg BJ, Netea MG. Interferon-gamma as adjunctive immunotherapy for invasive fungal infections: a case series. BMC Infect Dis. 2014 Mar 26;14:166. doi: 10.1186/1471-2334-14-166.
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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.
Mihai Netea, MD PhD study director
Radboud University Medical Center
Corine Delsing, MD principal investigator
Radboud University Medical Center
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 Interferon-gamma, Recombinant in people with Candidemia, run by Radboud University Medical Center at 1 site in Netherlands.
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 9 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 14 Feb 2012. 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 Netherlands. 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 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 Corine Delsing, MD (+31-24-3618819, C.Delsing@AIG.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to negative blood cultures (time frame: at fixed time points during follow up (at least until 8 weeks after end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270490, which also lists 1 linked publication.
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 14 Feb 2012.