Invasive Pulmonary AspergillosisPhase 4NCT01499433
Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
A Phase 4 study testing caspofungin in people with Invasive Pulmonary Aspergillosis and Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Pulmonary Aspergillosis, Chronic Obstructive Pulmonary Disease
- What is being tested?
- caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Nov 2014
- 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
- Proven invasive pulmonary aspergillosis
- Probable invasive pulmonary aspergillosis
- Hospitalized in respiratory wards
- Not having received an empirical antifungal therapy for 72h before inclusion
Who cannot join
- A history of allergy to echinocandins
- Severe renal failure, severe hepatic insufficiency
- Inadequately treated bacterial infection
- Documented HIV infection
- Status of pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, 510120
Nanshan Zhong, MD, 862083062888, Nanshan@vip.163.com
Feng Ye, MD
About this study
Official title: Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
The investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease.
Read the detailed description
Recently, there has been increasing appreciation of chronic obstructive pulmonary disease (COPD) as an important risk factor of invasive pulmoanry aspergillosis (IPA). However, clinical data on the morbidity and mortality of IPA underlying COPD as well as the efficacy and safety of antifungal treatment in such subset of patient population is very limited. In clinical pratice, capofungin is often used as primary antifungal therapy for IPA, especially in patients with impaired renal function. Based on this data, the investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying COPD.
- Being tested
- caspofungin
- Medical subject headings
- Invasive Pulmonary Aspergillosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofunginDrug
Also called brand name:Cancidas
Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days
| Study group | Role | What they receive |
|---|---|---|
| caspofungin | Experimental | Not described Receives: Drug: caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
The primary objective is to investigate the clinical efficacy of 3-week treatment with caspofungin as either primary or salvage antifungal therapy for IPA underlying COPD.
Measured: At end of intravenous treatment(three week)
Secondary outcomes (4)
Assessment of Safety of Caspofungin for IPA Underlying COPD
Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.
Measured: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.
Global response to 2-week caspofungin therapy
Measured: 2 week
Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy
Assessment of factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics,malnutrition or diabetes affecting patients' response to caspofungin therapy
Measured: 3 week
Clinical response at Day 7 of treatment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionSep 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Pulmonary AspergillosisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Feng Ye, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Feng Ye, MD, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499433
- Sponsor's protocol ID
- IISP# 39758
- Status last verified
- Jan 2014
- First submitted
- 16 Dec 2011
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01499433
- Acronym / sponsor ID
- IISP# 39758
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 26 Dec 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 investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease.
Detailed description
Recently, there has been increasing appreciation of chronic obstructive pulmonary disease (COPD) as an important risk factor of invasive pulmoanry aspergillosis (IPA). However, clinical data on the morbidity and mortality of IPA underlying COPD as well as the efficacy and safety of antifungal treatment in such subset of patient population is very limited. In clinical pratice, capofungin is often used as primary antifungal therapy for IPA, especially in patients with impaired renal function. Based on this data, the investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caspofungin | Experimental | Drug: caspofungin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Proven invasive pulmonary aspergillosis
- Probable invasive pulmonary aspergillosis
- Hospitalized in respiratory wards
- Not having received an empirical antifungal therapy for 72h before inclusion
Key exclusion criteria (5 listed)
- A history of allergy to echinocandins
- Severe renal failure, severe hepatic insufficiency
- Inadequately treated bacterial infection
- Documented HIV infection
- Status of pregnancy or lactation
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 |
|---|---|---|
| caspofunginAlso: brand name:CancidasCaspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days | Drug | caspofungin |
Primary outcome
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
Time frame: At end of intravenous treatment(three week)
The primary objective is to investigate the clinical efficacy of 3-week treatment with caspofungin as either primary or salvage antifungal therapy for IPA underlying COPD.
4 secondary outcomes
Assessment of Safety of Caspofungin for IPA Underlying COPD
Time frame: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.
Global response to 2-week caspofungin therapy
Time frame: 2 week
Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy
Time frame: 3 week
Clinical response at Day 7 of treatment
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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.
Feng Ye, MD principal investigator
Guangzhou Institute of Respiratory Disease
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 caspofungin in people with Invasive Pulmonary Aspergillosis and Chronic Obstructive Pulmonary Disease, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
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 4 inclusion and 5 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 23 Jan 2014. 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 China. 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 Feng Ye, MD (862083062836, yefeng@gird.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy (time frame: At end of intravenous treatment(three week)). It is what the study was designed to measure, not a finding.
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 23 Jan 2014.