IFI4056NCT01693887
Treatment Method Research of Invasive Pulmonary Fungal Infection
An observational study of IFI, run by West China Hospital at 4 sites in China.
Trial summary
The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated by different protocols(empirical therapy or preemptive therapy) in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IFI
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2012to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation
Who may be able to join
- More than 18 years old ，male or female
- Expected the time of staying in ICU longer than 72 hours and the duration of mechanical ventilation for more than 48 hours
- Pulmonary infection according to, axillary temperature≥ 37℃, using broad-spectrum antibiotics more than 72 hours, no better or worse
- Candida score greater than or equal to 3
- Child-bearing women, urine pregnancy test must be negative when screening and agreed to adopt safe and effective contraceptive measures in the process
- Male subjects must be guaranteed to use dual physical methods of contraception contraceptive and sperm donation, from starting to after 30days ending treatment
- Subjects ( or their legal representatives） have signed the informed consent
Who cannot join
- Diagnosed with invasive fungal infection by any of the following means at the time of admission 1）Proved deep fungal infection by histopathology 2）Peripheral blood culture fungi positive at least 1 time 3）Specimens from sterile sites of culture positive ( cerebrospinal fluid, pleural effusion and ascites）
- Renal insufficiency, creatinine clearance < 30ml/min
- Active liver disease or suspected drug induced liver injury
- Pregnant and lactating women
- With imidazole or pyrrolic drug allergy or intolerance or have contraindications.
- Not fit into the group by comprehensive judgment
Trial locations and contacts
4 sites in 1 country.
China4 sites
Third people's Hospital of Chengdu City
Chengdu, Sichuan, 610031
West China Hospital
Chengdu, Sichuan, 610041
Sichuan provincial people's hospital
Chengdu, Sichuan, 610071
Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004
About this study
Official title: A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China
The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated by different protocols(empirical therapy or preemptive therapy) in ICU.
Read the detailed description
a multicenter study ( a total of 2411 person-time ) found In the United States in 205, antifungal therapy in empirical therapy, preemptive therapy, target therapy of respectively 44%, 43%, 12%. While the existing on preemptive therapy and empiric treatment comparative study shows, the survival rate of the patients without differences, cost and application of antifungal drugs are relatively more in empirical therapy. These findings of differences, is due to the different research forecast model, treatment options vary widely, and are without a prospective multicenter study of verification. Initiation of antifungal therapy time and antifungal drug of choice is affected by many factors, including the risk stratification of patients, clinical manifestations, bacterial infection of evidence and non interventional diagnosis method results. How to grasp the opportunity to treat the fungal infections by empirical therapy or preemptive therapy that has plagued the global clinical doctors. The purpose of this study is aimed at the large scale prospective, multicenter study method to China, severe invasive pulmonary fungal infection of the empiric treatment with preemptive therapy for clinical contrast research, exploration of fungal treatment time and plan, to establish China's own optimal antifungal treatment options, are reduced in patients with severe fungal infection harm and increase the rate of successful treatment with evidence-based medical evidence.
- Conditions
- IFI
- Keywords
- IFI, empirical therapy, preemptive therapy, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| empirical therapy | immediate initiation of antifungal therapy; Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) | |
| preemptive therapy | Dynamic monitoring of fungal infection, initiation antifungal therapy when clinical diagnosis ( microbial + experiment +, G/GM, CT typical change ) approveled in two weeks Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) If within two weeks without obtaining positive results, researchers determine whether initiation of antifungal therapy。 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: The study difficulty is more serious than expected. The budget isn't enough.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IFIStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yan kang, West China Hospital
- Investigators
- yan kang, director, Principal investigator, West China Hospitalxiao bo huang, director, Study director, Sichuan Provincial People's Hospitalchuan zhang, director, Study director, Third people's Hospital of Chengdu Citydi-fen wang, director, Study director, Affiliated Hospital of Guiyang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693887
- Sponsor's protocol ID
- ITRFUN4056
- Acronym
- 4056
- Status last verified
- Dec 2015
- First submitted
- 21 Sep 2012
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China
- ClinicalTrials.gov ID
- NCT01693887
- Acronym / sponsor ID
- 4056 / ITRFUN4056
- Conditions
- IFI
- Keywords
- IFI, empirical therapy, preemptive therapy, Itraconazole
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study difficulty is more serious than expected. The budget isn't enough.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Sep 2012 (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 Comparison clinical efficiency with IPFI patients who treated by different protocols(empirical therapy or preemptive therapy) in ICU.
Detailed description
a multicenter study ( a total of 2411 person-time ) found In the United States in 205, antifungal therapy in empirical therapy, preemptive therapy, target therapy of respectively 44%, 43%, 12%. While the existing on preemptive therapy and empiric treatment comparative study shows, the survival rate of the patients without differences, cost and application of antifungal drugs are relatively more in empirical therapy. These findings of differences, is due to the different research forecast model, treatment options vary widely, and are without a prospective multicenter study of verification. Initiation of antifungal therapy time and antifungal drug of choice is affected by many factors, including the risk stratification of patients, clinical manifestations, bacterial infection of evidence and non interventional diagnosis method results. How to grasp the opportunity to treat the fungal infections by empirical therapy or preemptive therapy that has plagued the global clinical doctors. The purpose of this study is aimed at the large scale prospective, multicenter study method to China, severe invasive pulmonary fungal infection of the empiric treatment with preemptive therapy for clinical contrast research, exploration of fungal treatment time and plan, to establish China's own optimal antifungal treatment options, are reduced in patients with severe fungal infection harm and increase the rate of successful treatment with evidence-based medical evidence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| empirical therapy | – | –immediate initiation of antifungal therapy; Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) |
| preemptive therapy | – | –Dynamic monitoring of fungal infection, initiation antifungal therapy when clinical diagnosis ( microbial + experiment +, G/GM, CT typical change ) approveled in two weeks Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) If within two weeks without obtaining positive results, researchers determine whether initiation of antifungal therapy。 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation
Key inclusion criteria (7 listed)
- More than 18 years old ，male or female
- Expected the time of staying in ICU longer than 72 hours and the duration of mechanical ventilation for more than 48 hours
- Pulmonary infection according to, axillary temperature≥ 37℃, using broad-spectrum antibiotics more than 72 hours, no better or worse
- Candida score greater than or equal to 3
- Child-bearing women, urine pregnancy test must be negative when screening and agreed to adopt safe and effective contraceptive measures in the process
Key exclusion criteria (6 listed)
- Diagnosed with invasive fungal infection by any of the following means at the time of admission 1）Proved deep fungal infection by histopathology 2）Peripheral blood culture fungi positive at least 1 time 3）Specimens from sterile sites of culture positive ( cerebrospinal fluid, pleural effusion and ascites）
- Renal insufficiency, creatinine clearance < 30ml/min
- Active liver disease or suspected drug induced liver injury
- Pregnant and lactating women
- With imidazole or pyrrolic drug allergy or intolerance or have contraindications.
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 was stopped early (reason given: The study difficulty is more serious than expected. The budget isn't enough.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
Related trials for IFI
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
Active, not recruitingObservational study
Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT
Tuberculosis (TB), End-Stage Kidney Disease
RecruitingPhase 2
Interferon Gamma Plus Camrelizumab as Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Locally Advanced Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
Active, not recruitingPhase 2
Interferon-gamma as Adjunctive Therapy in Chronic Pulmonary Aspergillosis: a Randomised Feasibility Study
Chronic Pulmonary Aspergillosis, Aspergillosis
RecruitingPhase 2/3
Effect of Interferon Gamma as a Treatment for Post-aggressive Immunosuppression in Intensive Care Units, a Randomized Bayesian Double-blind Controlled Trial Versus Placebo
Post-aggressive Immunosuppression, Adult Patients Admitted to Intensive Care With Initial Severity (SOFA of the First 24 Hours Post-admission ≥ 6
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.
yan kang, director principal investigator
West China Hospital
xiao bo huang, director study director
Sichuan Provincial People's Hospital
chuan zhang, director study director
Third people's Hospital of Chengdu City
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IFI, run by West China Hospital at 4 sites 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 7 inclusion and 6 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study was stopped early (reason given: The study difficulty is more serious than expected. The budget isn't enough.). 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.
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 11 Dec 2015.