NeutropeniaNCT00008840
A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
An observational study of Neutropenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Neutropenia
- How many people
- 866 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2005
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are at least 12 years of age.
- Are hospitalized with low white blood cell counts.
- Have received at least 96 hours of IV antibiotics.
- Have an oral temperature (or equivalent) of 38.0 C (100.4 F) or greater within the 24 hours before the study starts.
- Are not pregnant or breast-feeding.
- Agree to use a barrier method of contraception (e.g., a condom) during the study
Who cannot join
- You will not be eligible for this study if you:
- Have a serious fungal infection.
- Have a history of an allergic reaction to antifungal agents.
- Are taking certain medications which may interfere with the study drug.
- Are participating in a clinical trial of any investigational drug.
- Have previously participated in this trial.
- Have any conditions which could affect your safety, make evaluation of response difficult, or make it unlikely that you can complete the course of therapy.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.
Read the detailed description
Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.
- Conditions
- Neutropenia
- Medical subject headings
- Neutropenia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Enrolment
- 866 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008840
- Sponsor's protocol ID
- DMID MSG 42
- Other IDs
- 150-603
- Status last verified
- Nov 2005
- First submitted
- 18 Jan 2001
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
- ClinicalTrials.gov ID
- NCT00008840
- Acronym / sponsor ID
- DMID MSG 42
- Conditions
- Neutropenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 866 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 2005
- First posted
- 31 Aug 2001 (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 evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.
Detailed description
Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 12 years of age.
- Are hospitalized with low white blood cell counts.
- Have received at least 96 hours of IV antibiotics.
- Have an oral temperature (or equivalent) of 38.0 C (100.4 F) or greater within the 24 hours before the study starts.
- Are not pregnant or breast-feeding.
Key exclusion criteria (7 listed)
- Have a serious fungal infection.
- Have a history of an allergic reaction to antifungal agents.
- Are taking certain medications which may interfere with the study drug.
- Are participating in a clinical trial of any investigational drug.
- Have previously participated in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 27 Aug 2010. 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 United States. 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.
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.
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 27 Aug 2010.