Treatment Method Research of Invasive Pulmonary Fungal Infection (4056)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by West China Hospital
Sponsor:
Information provided by (Responsible Party):
yan kang, West China Hospital
ClinicalTrials.gov Identifier:
NCT01693887
First received: September 21, 2012
Last updated: September 25, 2012
Last verified: August 2011
  Purpose

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.


Condition
IFI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Estimated Enrollment: 330
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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。

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693887

Contacts
Contact: yan kang, director 86-028-85422508
Contact: xiao qi xie, physician 86-028-85422739 xiaoqixie@hotmail.com

Locations
China, Guizhou
Affiliated Hospital of Guiyang Medical College Not yet recruiting
Guiyang, Guizhou, China, 550004
Contact: di-fen wang, Director         
Principal Investigator: di-fen wang, Director         
Sub-Investigator: yuan-yi liu, Physician         
China, Sichuan
West China Hospital Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: xiao qi xie, physician    86-028-85422739      
Principal Investigator: yan kang, Director         
Sub-Investigator: xiao qi xie, physician         
Sichuan provincial people's hospital Recruiting
Chengdu, Sichuan, China, 610071
Contact: xiao-bo Huang, director    86-028-87393247      
Principal Investigator: xiao bo huang, director         
Sub-Investigator: yi-ping Wang, physician         
Sub-Investigator: xiao-qin zhang, physician         
Third people's Hospital of Chengdu City Not yet recruiting
Chengdu, Sichuan, China, 610031
Contact: chuan zhang, Director         
Principal Investigator: chuan zhang, Director         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: yan kang, director(ICU), West China Hospital
ClinicalTrials.gov Identifier: NCT01693887     History of Changes
Other Study ID Numbers: ITRFUN4056
Study First Received: September 21, 2012
Last Updated: September 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by West China Hospital:
IFI
empirical therapy
preemptive therapy
Itraconazole

Additional relevant MeSH terms:
Lung Diseases, Fungal
Mycoses
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Itraconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014