Treatment Method Research of Invasive Pulmonary Fungal Infection

IFI Clinical Trial

— 4056  

Official title:

A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01693887
• Other study ID #: ITRFUN4056
• Status: Terminated
• Phase: N/A
• First received: September 21, 2012
• Last updated: December 10, 2015
• Start date: August 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2015
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• IFI
• Lung Diseases, Fungal
• Mycoses

Locations

Country	Name	City	State
China	Sichuan provincial people's hospital	Chengdu	Sichuan
China	Third people's Hospital of Chengdu City	Chengdu	Sichuan
China	West China Hospital	Chengdu	Sichuan
China	Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China,