Treatment Method Research of Invasive Pulmonary Fungal Infection (4056)

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.

Study Overview

• Status: Terminated
• Conditions: IFI

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • Affiliated Hospital of Guiyang Medical College
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital
    • Chengdu, Sichuan, China, 610071
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China, 610031
      • Third people's Hospital of Chengdu City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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。

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: yan kang, director, West China Hospital; Study Director: xiao bo huang, director, Sichuan Provincial People's Hospital; Study Director: chuan zhang, director, Third people's Hospital of Chengdu City; Study Director: di-fen wang, director, Affiliated Hospital of Guiyang Medical College

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2015
• Last Update Submitted That Met QC Criteria: December 10, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Itraconazole; IFI; empirical therapy; preemptive therapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections and Mycoses; Mycoses; Lung Diseases, Fungal
• Other Study ID Numbers: ITRFUN4056