SepsisPhase 4AMBIDEXNCT00697944
Ambisome® Preemptive Treatment of Multiple Candida Colonization in Sepsis Patients
A Phase 4 study testing Amphotericine in liposome (Ambisome®) in people with Sepsis and Candida, run by Fovea at 2 sites in France.
Trial summary
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation. Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Amphotericine in liposome (Ambisome®)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2008to Mar 2009
- 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
- Supportive mechanical ventilation for more than 48 h
- LOD > 5 with with ailing body systems
- Candida colonisation of at least one site in addition to the digestive tract
- Suspected nosocomial infection with antibiotic treatment
- Informed consent
Who cannot join
- Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
- Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
- Patients with a SAPS score > 65
- Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
- Blood creatinine > 220 µmol/L
- Hemodyalysis
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Chu Michallon
Grenoble, 38000
TIMSIT, jftimsit@chu-grenoble.fr
- Not yet recruiting
Hopital Saint Louis
Paris, 75010
About this study
Official title: Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.
Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.
The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed
- Being tested
- Amphotericine in liposome (Ambisome®)
- Keywords
- FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation
- Medical subject headings
- Sepsis, Torulopsis, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericine in liposome (Ambisome®)Drug
2 IV infusions separated by one week 10 mg/kg per injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
Measured: 28-day observation period
Secondary outcomes (1)
Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
Measured: 28 days after first treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009 (estimated)
- Study completionMar 2009 (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 SepsisStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fovea
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Investigators
- Elie AZOULAY, MD PhD, Principal investigator, University Teaching Hospital Saint Louis, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697944
- Sponsor's protocol ID
- AMBIDEX
- Other IDs
- EUDRA-CT 2007-004444-71
- Acronym
- AMBIDEX
- Status last verified
- Mar 2009
- First submitted
- 12 Jun 2008
- Last updated
- 16 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.
PubMed 28531175
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambisome® Preemptive Treatment of Multiple Colonizations by Candida in Intensive Care Patients With a Sepsis
- ClinicalTrials.gov ID
- NCT00697944
- Acronym / sponsor ID
- AMBIDEX / AMBIDEX
- Keywords
- FUNGAL INFECTION, SEPSIS, INTENSIVE CARE, AMBISOME, PREEMPTIVE TREATMENT, Sepsis with candida colonisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- FoveaUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 16 Jun 2008 (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.
To assess the safety of Ambisome 10 mg/kg/week in patients as a preemptive treatment in intensive care patients with a sepsis and rising candida colonisation.
Preemptive treatment (i.e., prophylactic treatment with two high doses of Ambisome® administered with an interval of one week, in patiens with a high risk of developing a fungal infection) should decrease the incidence of actual systemic infections.
The incidence of such actual fungal infections will be assessed directly and its impact on patients' survival and intensive care resourches assessed
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Supportive mechanical ventilation for more than 48 h
- LOD > 5 with with ailing body systems
- Candida colonisation of at least one site in addition to the digestive tract
- Suspected nosocomial infection with antibiotic treatment
- Informed consent
Key exclusion criteria (7 listed)
- Patients treated with oral or systemic antifungal agents within 15 days prior to inclusion
- Patients requiring treatment with an antifungal agent or with a documented (proven or probable) fungal infection according to the EORTC criteria
- Patients with a SAPS score > 65
- Patients with neutropenia of that underwent a bone marrow tar organ transplant or with cancer chemotherapy
- Blood creatinine > 220 µmol/L
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 |
|---|---|---|
| Amphotericine in liposome (Ambisome®)2 IV infusions separated by one week 10 mg/kg per injection | Drug | – |
Primary outcome
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects
Time frame: 28-day observation period
1 secondary outcome
Duration of stay in the intensive care unit; occurrence of a systemic fungal infection
Time frame: 28 days after first treatment administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2008.
- Derived from this study: PubMed 28531175Azoulay E, Timsit JF, Lautrette A, Legriel S, Max A, Ruckly S, Misset B, Cohen Y, Wolff M. Weekly high-dose liposomal amphotericin B (L-AmB) in critically ill septic patients with multiple Candida colonization: The AmBiDex study. PLoS One. 2017 May 22;12(5):e0177093. doi: 10.1371/journal.pone.0177093. eCollection 2017.
Related trials for Sepsis
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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.
Elie AZOULAY, MD PhD principal investigator
University Teaching Hospital Saint Louis, Paris
2 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 Amphotericine in liposome (Ambisome®) in people with Sepsis and Candida, run by Fovea at 2 sites 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 5 inclusion and 7 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 16 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François RI DREYFUS, MD PhD (33-61-282-6780, jfdreyfus@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global assessment of severity of adverse events; incidence, severity and consequences of treatment emergent effects (time frame: 28-day observation period). 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 NCT00697944, 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 16 Jun 2008.