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Treatment Method Research of Invasive Pulmonary Fungal Infection (4056)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693887
Recruitment Status : Terminated (The study difficulty is more serious than expected. The budget isn't enough.)
First Posted : September 26, 2012
Last Update Posted : December 11, 2015
Information provided by (Responsible Party):
yan kang, West China Hospital

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.

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 7 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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。

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693887

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China, Guizhou
Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China, 550004
China, Sichuan
Third people's Hospital of Chengdu City
Chengdu, Sichuan, China, 610031
West China Hospital
Chengdu, Sichuan, China, 610041
Sichuan provincial people's hospital
Chengdu, Sichuan, China, 610071
Sponsors and Collaborators
West China Hospital
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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

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Responsible Party: yan kang, director(ICU), West China Hospital Identifier: NCT01693887    
Other Study ID Numbers: ITRFUN4056
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by yan kang, West China Hospital:
empirical therapy
preemptive therapy
Additional relevant MeSH terms:
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Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors