Malignant HemopathyPhase 4NCT00190463
Comparison of 2 Antifungal Treatment (Empirical Versus Pre-Empirical) Strategies in Prolonged Neutropenia
A Phase 4 study testing Amphotericin B in people with Malignant Hemopathy and Duration of Neutropenia Following Chemotherapy > 10 Days, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hemopathy, Duration of Neutropenia Following Chemotherapy > 10 Days
- What is being tested?
- Amphotericin B
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2003to Jul 2006
- 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
- Malignant Hemopathy
- Induction or consolidation phase of chemotherapy, with expected neutropenia (< 500/mm3) during at least 10 days
- Hospitalisation during aplasia
Who cannot join
- allogeneic haematopoietic stem cell transplants
- Previous fungal infection according to EORTC-MSG criteria
- Active fungal infection according to EORTC-MSG criteria
- Previous anaphylactic intolerance to polyenes
- known aspergillosis infection
- Sepsis
- Pneumopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"
Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.
Read the detailed description
Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of > 10 days. Patients are randomized according to a 1:1 ratio to receive either the usual empirical strategy (antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical strategy (administration of antifungals is limited to patients with pneumonia, septic shock, sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or positive galactomannan antigenemia). The antifungals administered are deoxycholate amphotericin B or liposome amphotericin B, according to the creatinin clearance. This strategy is applied during the first 14 days of persistent fever, then the therapy is left at the discretion of the investigator. The primary endpoint is survival at neutrophil recovery, or, in case of persistent neutropenia, at day 60 at the latest. Secondary objectives are the incidence of invasive fungal infections (IFI), IFI-free survival, number of febrile days, and renal function at study completion.
- Being tested
- Amphotericin B
- Keywords
- aspergillosis, antifungal therapy, empirical antifungal treatment
- Medical subject headings
- Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin BDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 60 days
Secondary outcomes (3)
Day with fever
Fungal infections
Costs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2003
- Study completionJul 2006
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 Malignant HemopathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Catherine CORDONNIER, Pr,MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190463
- Sponsor's protocol ID
- P020905
- Other IDs
- AOR02028
- Status last verified
- Sep 2006
- First submitted
- 15 Sep 2005
- Last updated
- 21 Sep 2006
- Results posted
- No
Publications
Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
PubMed 11850858
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias ". Study "PREVERT"
- ClinicalTrials.gov ID
- NCT00190463
- Acronym / sponsor ID
- P020905
- Keywords
- aspergillosis, antifungal therapy, empirical antifungal treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 300 participants
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Jul 2006
- First posted
- 19 Sep 2005 (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.
Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. The rational is that fungal infections are difficult to early diagnose, and are life-threatening. Historical trials have shown a small benefit of survival when this strategy is used. According to the drug usde for this strategy, safety and costs may be concerns. However, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.
Detailed description
Patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of > 10 days. Patients are randomized according to a 1:1 ratio to receive either the usual empirical strategy (antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical strategy (administration of antifungals is limited to patients with pneumonia, septic shock, sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or positive galactomannan antigenemia). The antifungals administered are deoxycholate amphotericin B or liposome amphotericin B, according to the creatinin clearance. This strategy is applied during the first 14 days of persistent fever, then the therapy is left at the discretion of the investigator. The primary endpoint is survival at neutrophil recovery, or, in case of persistent neutropenia, at day 60 at the latest. Secondary objectives are the incidence of invasive fungal infections (IFI), IFI-free survival, number of febrile days, and renal function at study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (3 listed)
- Malignant Hemopathy
- Induction or consolidation phase of chemotherapy, with expected neutropenia (< 500/mm3) during at least 10 days
- Hospitalisation during aplasia
Key exclusion criteria (7 listed)
- allogeneic haematopoietic stem cell transplants
- Previous fungal infection according to EORTC-MSG criteria
- Active fungal infection according to EORTC-MSG criteria
- Previous anaphylactic intolerance to polyenes
- known aspergillosis infection
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 |
|---|---|---|
| Amphotericin B | Drug | – |
Primary outcome
Mortality at 60 days
3 secondary outcomes
Day with fever
Fungal infections
Costs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2006.
- Background: PubMed 11850858Hughes WT, Armstrong D, Bodey GP, Bow EJ, Brown AE, Calandra T, Feld R, Pizzo PA, Rolston KV, Shenep JL, Young LS. 2002 guidelines for the use of antimicrobial agents in neutropenic patients with cancer. Clin Infect Dis. 2002 Mar 15;34(6):730-51. doi: 10.1086/339215. Epub 2002 Feb 13. No abstract available.
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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.
Catherine CORDONNIER, Pr,MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amphotericin B in people with Malignant Hemopathy and Duration of Neutropenia Following Chemotherapy > 10 Days, run by Assistance Publique - Hôpitaux de Paris 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 3 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: stopped early, as of the sponsor's last update on 21 Sep 2006. 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. 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 was stopped early. Results are not available in the source record.
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?
Mortality at 60 days. 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 NCT00190463, 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 21 Sep 2006.