Clinical trial NCT01693887: Treatment Method Research of Invasive Pulmonary Fungal Infection
Official title: A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: IFI
Keywords: IFI
empirical therapy
preemptive therapy
Itraconazole
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. More than 18 years old ，male or female
2. Expected the time of staying in ICU longer than 72 hours and the duration of mechanical ventilation for more than 48 hours
3. Pulmonary infection according to, axillary temperature≥ 37℃, using broad-spectrum antibiotics more than 72 hours, no better or worse
4. Candida score greater than or equal to 3
5. Child-bearing women, urine pregnancy test must be negative when screening and agreed to adopt safe and effective contraceptive measures in the process
6. Male subjects must be guaranteed to use dual physical methods of contraception contraceptive and sperm donation, from starting to after 30days ending treatment
7. Subjects ( or their legal representatives） have signed the informed consent

Exclusion Criteria:

1. 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）
2. Renal insufficiency, creatinine clearance \< 30ml/min
3. Active liver disease or suspected drug induced liver injury
4. Pregnant and lactating women
5. With imidazole or pyrrolic drug allergy or intolerance or have contraindications.
6. Not fit into the group by comprehensive judgment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Chengdu
country: China
facility: Third people's Hospital of Chengdu City
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan provincial people's hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: yan kang, director
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Provincial People's Hospital
name: xiao bo huang, director
role: STUDY_DIRECTOR
affiliation: Third people's Hospital of Chengdu City
name: chuan zhang, director
role: STUDY_DIRECTOR
affiliation: Affiliated Hospital of Guiyang Medical College
name: di-fen wang, director
role: STUDY_DIRECTOR
References: