Pulmonary CandidiasisPhase 4NCT00537888
Clinical Significance of Smear or Culture Positive for Candida Spp. From Sputum Three Times a Week
A Phase 4 study testing fluconazole in people with Pulmonary Candidiasis, run by Capital Medical University at 1 site in China.
Trial summary
The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Pulmonary Candidiasis
- What is being tested?
- fluconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2007to Dec 2011
- 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 85ys>age>14ys
- APACHE II<25
- Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
- smear or culture positive for candida spp. from sputum
Who cannot join
- Pregnancy
- Hypersensitivity to fluconazole
- Isolated candida was non-sensitive to fluconazole
- Severe liver or renal diseases who can not tolerate fluconazole treatment
- With at least one of the following high risk factors:organ transplantation, neutropenia>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
- With one of the microbiological evidence:isolation of candida spp. from blood or other kinds of sterile site(not including urine), filamentous fungi isolated from sputum or BALF, cryptococcus isolated from sputum or CSF, galactomannan antigen positive twice for blood
- Probable or possible pulmonary aspergillosis
- Definite oral or esophageal candidiasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital,Affiliate of Capital Medical University
Beijing, Beijing Municipality, 100020
Bin Cao, doctor
About this study
Official title: Diagnosis of Pulmonary Candidiasis
The definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.
- Conditions
- Pulmonary Candidiasis
- Being tested
- fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluconazoleDrug
Intravenous or oral 400 md/d
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive candidiasis
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (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 Pulmonary CandidiasisStudies of the same condition, open and under way.
- More trials run by Capital 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Bin Cao, Doctor, Principal investigator, Beijing Chaoyang Hospital, Affiliate of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537888
- Sponsor's protocol ID
- CYH-CMU
- Status last verified
- Jul 2009
- First submitted
- 1 Oct 2007
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cao B, Cai BQ, Wang H, Zhou CY, Wang P, Liu HR, Zhang H, Xu L, Xu KF, Xu WB, Zhu YJ, Li XG. [A study of 152 cases of pulmonary fungal infection: reevaluation of the microbiological spectra]. Zhonghua Jie He He Hu Xi Za Zhi. 2007 Apr;30(4):279-83. Chinese.
PubMed 17651612
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Pulmonary Candidiasis
- ClinicalTrials.gov ID
- NCT00537888
- Acronym / sponsor ID
- CYH-CMU
- Conditions
- Pulmonary Candidiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Oct 2007 (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 definition of pulmonary candidiasis is still unclear.In China, isolation of candida spp. form sputum twice or three times a week has been regarded as the microbiological evidence of pulmonary candidiasis. The investigators hypothesize that patients who present respiratory symptoms and lung infiltrates together with smear of culture positive for candida spp. from sputum three times a week can not be diagnosed as pulmonary candidiasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 85ys>age>14ys
- APACHE II<25
- Lung infiltrates together with at least one of the following symptoms:cough, sputum, dyspnea with or without fever
- smear or culture positive for candida spp. from sputum
Key exclusion criteria (8 listed)
- Pregnancy
- Hypersensitivity to fluconazole
- Isolated candida was non-sensitive to fluconazole
- Severe liver or renal diseases who can not tolerate fluconazole treatment
- With at least one of the following high risk factors:organ transplantation, neutropenia>10ds, long term glucocorticoids therapy(equal to prednisone 30mg/d longer than 2 weeks), immunosuppressive therapy within 30ds, AIDS
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 |
|---|---|---|
| fluconazoleIntravenous or oral 400 md/d | Drug | – |
Primary outcome
invasive candidiasis
Time frame: in hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
- Results publication: PubMed 17651612Cao B, Cai BQ, Wang H, Zhou CY, Wang P, Liu HR, Zhang H, Xu L, Xu KF, Xu WB, Zhu YJ, Li XG. [A study of 152 cases of pulmonary fungal infection: reevaluation of the microbiological spectra]. Zhonghua Jie He He Hu Xi Za Zhi. 2007 Apr;30(4):279-83. Chinese.
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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.
Bin Cao, Doctor principal investigator
Beijing Chaoyang Hospital, Affiliate of Capital Medical University
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 fluconazole in people with Pulmonary Candidiasis, run by Capital 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 8 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 14 Dec 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 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 Bin Cao, doctor (8610-85231130, caobin1999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
invasive candidiasis (time frame: in hospital). 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 NCT00537888, 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 14 Dec 2010.