Lung TransplantationPhase 3NCT00177684
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
A Phase 3 study testing Amphotericin B in people with Lung Transplantation and Fungal Infections, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive aspergillosis (IA) in their lungs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation, Fungal Infections
- What is being tested?
- Amphotericin B
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2005
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female lung transplant recipients at University of Pittsburgh Medical Center ≥ 18yrs of age will be eligible for the study. Subjects HIV status will not determine the exclusion from study.
Who cannot join
- Pregnant women or women who are currently breast-feeding an infant
- Hypersensitive to amphotericin deoxycholate or lipid complex amphotericin B (Abelcet ®)
- Have a documented fungal infection
- Receipt of inhalational or IV amphotericin B within last 30 days
- Have a Temp ≥ 38ºC
- Hypoxemic (pulse oximeter < 92% at room air.)
- On mechanical ventilator
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization
Read the detailed description
Subject's visit for teaching and administration of the first dose of aerosolized liposomal Amphotericin will be performed at the specified intervals before the scheduled bronchoscopy.
Subject will receive first dose of the aerosolized liposomal amphotericin under direct supervision of physician and study coordinator. This visit will last approximately 2 hours.
Subject's spirometry will be performed before (standard of care) and after the administration (research related) of first dose aerosolized liposomal amphotericin. Each spirometry measurement takes approximately 1 hour. Prior to administration, blood pressure and heart rate will be obtained.
In the absence of any significant side effect of the aerosolized liposomal amphotericin (e.g., wheezing, shortness of breath, drop in FEV1 > 15%, the remaining three doses will be dispensed to the patient through pharmacy. The subject will be instructed on how to measure his/her peak flow rate before and after taking the aerosolized liposomal amphotericin. (approximately 1 hour) A 24 hr study pager number will be given to subjects to contact the investigators in case of development of side effects such as shortness of breath, wheezing, heaviness in the chest.
The study coordinator will contact the subject daily to ensure the compliance with the aerosolized liposomal amphotericin administration and monitor any untoward effects. This phone contact will not take longer than 10 minutes of the participant's time.
Drug administration: Subjects will be dispensed vials of ABELCET ® and will be taught by the study coordinator/investigators to draw drug from the vial to nebulizer. Detailed written instructions will also be provided to the subjects. In addition subjects will prove the comprehension of the instructions by demonstrating the procedure, to the study coordinator during initial visit. The description for the patient is as follows "Before administering the drug via nebulization, shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET ® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET ® and replace with the 5-micron filter needle supplied with each vial. Put no more than 7 ml of ABELCET ® in the nebulizer and inhaled over a period of 15 minutes. Continue the inhalation process until whole the amount is used up. Repeat the procedure with additional drug if your doctor has prescribed more drug for you". Aero Eclipse Nebulizer and Devilbliss 8650D compressor will be used for the study.
- Conditions
- Lung Transplantation, Fungal Infections
- Being tested
- Amphotericin B
- Medical subject headings
- Mycoses
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.
To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).
Secondary outcomes (1)
To determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of a four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization in lung transplant recipients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2005
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 Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Enzon Pharmaceuticals, Inc.
- Investigators
- Mark Ludwig, Study director, Enzon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177684
- Sponsor's protocol ID
- IRB # 0407015
- Status last verified
- Dec 2008
- First submitted
- 13 Sep 2005
- Last updated
- 17 Dec 2008
- Results posted
- No
Publications
Husain S, Capitano B, Corcoran T, Studer SM, Crespo M, Johnson B, Pilewski JM, Shutt K, Pakstis DL, Zhang S, Carey ME, Paterson DL, McCurry KR, Venkataramanan R. Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. Transplantation. 2010 Dec 15;90(11):1215-9. doi: 10.1097/TP.0b013e3181f995ea.
PubMed 20881664
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
- ClinicalTrials.gov ID
- NCT00177684
- Acronym / sponsor ID
- IRB # 0407015
- Conditions
- Lung Transplantation, Fungal Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Enzon Pharmaceuticals, Inc.
- Study start
- Sep 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 15 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.
The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive aspergillosis (IA) in their lungs. Additionally, the investigators hope to determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization
Detailed description
Subject's visit for teaching and administration of the first dose of aerosolized liposomal Amphotericin will be performed at the specified intervals before the scheduled bronchoscopy.
Subject will receive first dose of the aerosolized liposomal amphotericin under direct supervision of physician and study coordinator. This visit will last approximately 2 hours.
Subject's spirometry will be performed before (standard of care) and after the administration (research related) of first dose aerosolized liposomal amphotericin. Each spirometry measurement takes approximately 1 hour. Prior to administration, blood pressure and heart rate will be obtained.
In the absence of any significant side effect of the aerosolized liposomal amphotericin (e.g., wheezing, shortness of breath, drop in FEV1 > 15%, the remaining three doses will be dispensed to the patient through pharmacy. The subject will be instructed on how to measure his/her peak flow rate before and after taking the aerosolized liposomal amphotericin. (approximately 1 hour) A 24 hr study pager number will be given to subjects to contact the investigators in case of development of side effects such as shortness of breath, wheezing, heaviness in the chest.
The study coordinator will contact the subject daily to ensure the compliance with the aerosolized liposomal amphotericin administration and monitor any untoward effects. This phone contact will not take longer than 10 minutes of the participant's time.
Drug administration: Subjects will be dispensed vials of ABELCET ® and will be taught by the study coordinator/investigators to draw drug from the vial to nebulizer. Detailed written instructions will also be provided to the subjects. In addition subjects will prove the comprehension of the instructions by demonstrating the procedure, to the study coordinator during initial visit. The description for the patient is as follows "Before administering the drug via nebulization, shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of ABELCET ® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with ABELCET ® and replace with the 5-micron filter needle supplied with each vial. Put no more than 7 ml of ABELCET ® in the nebulizer and inhaled over a period of 15 minutes. Continue the inhalation process until whole the amount is used up. Repeat the procedure with additional drug if your doctor has prescribed more drug for you". Aero Eclipse Nebulizer and Devilbliss 8650D compressor will be used for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female lung transplant recipients at University of Pittsburgh Medical Center ≥ 18yrs of age will be eligible for the study. Subjects HIV status will not determine the exclusion from study.
Key exclusion criteria (7 listed)
- Pregnant women or women who are currently breast-feeding an infant
- Hypersensitive to amphotericin deoxycholate or lipid complex amphotericin B (Abelcet ®)
- Have a documented fungal infection
- Receipt of inhalational or IV amphotericin B within last 30 days
- Have a Temp ≥ 38ºC
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
To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).
1 secondary outcome
To determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of a four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization in lung transplant recipients.
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 17 Dec 2008.
- Derived from this study: PubMed 20881664Husain S, Capitano B, Corcoran T, Studer SM, Crespo M, Johnson B, Pilewski JM, Shutt K, Pakstis DL, Zhang S, Carey ME, Paterson DL, McCurry KR, Venkataramanan R. Intrapulmonary disposition of amphotericin B after aerosolized delivery of amphotericin B lipid complex (Abelcet; ABLC) in lung transplant recipients. Transplantation. 2010 Dec 15;90(11):1215-9. doi: 10.1097/TP.0b013e3181f995ea.
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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.
Mark Ludwig study director
Enzon Pharmaceuticals, Inc.
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 Amphotericin B in people with Lung Transplantation and Fungal Infections, run by University of Pittsburgh 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 1 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 17 Dec 2008. 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.
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?
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?
To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®).. 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 NCT00177684, 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 17 Dec 2008.