Treatment Method Research of Invasive Pulmonary Fungal Infection

NCT ID: NCT01693887

Last Updated: 2015-12-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-11-30

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.

Conditions

IFI

Keywords

IFI; empirical therapy; preemptive therapy; Itraconazole

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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。

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

yan kang

director（ICU）

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yan kang, director

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

xiao bo huang, director

Role: STUDY_DIRECTOR

Sichuan Provincial People's Hospital

chuan zhang, director

Role: STUDY_DIRECTOR

Third people's Hospital of Chengdu City

di-fen wang, director

Role: STUDY_DIRECTOR

Affiliated Hospital of Guiyang Medical College

Locations

Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, China

Third people's Hospital of Chengdu City

Chengdu, Sichuan, China

West China Hospital

Chengdu, Sichuan, China

Sichuan provincial people's hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ITRFUN4056

Identifier Type: -

Identifier Source: org_study_id