Treatment Method Research of Invasive Pulmonary Fungal Infection

NCT01693887 | Terminated DMC

• 1 other identifier: ITRFUN4056
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 4

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.

Conditions

IFI

Keywords

IFI; empirical therapy; preemptive therapy; Itraconazole

Study Arms (2)

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。

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation

You may qualify if:

• More than 18 years old ，male or female
• Expected the time of staying in ICU longer than 72 hours and the duration of mechanical ventilation for more than 48 hours
• Pulmonary infection according to, axillary temperature≥ 37℃, using broad-spectrum antibiotics more than 72 hours, no better or worse
• Candida score greater than or equal to 3
• Child-bearing women, urine pregnancy test must be negative when screening and agreed to adopt safe and effective contraceptive measures in the process
• Male subjects must be guaranteed to use dual physical methods of contraception contraceptive and sperm donation, from starting to after 30days ending treatment
• Subjects ( or their legal representatives） have signed the informed consent

You may not qualify if:

• 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）
• Renal insufficiency, creatinine clearance \< 30ml/min
• Active liver disease or suspected drug induced liver injury
• Pregnant and lactating women
• With imidazole or pyrrolic drug allergy or intolerance or have contraindications.
• Not fit into the group by comprehensive judgment

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (4)

Affiliated Hospital of Guiyang Medical College

Guiyang, Guizhou, 550004, China

Location

Third people's Hospital of Chengdu City

Chengdu, Sichuan, 610031, China

Location

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Sichuan provincial people's hospital

Chengdu, Sichuan, 610071, China

Location

Study Officials

• yan kang, director

  West China Hospital

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director（ICU）

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 26, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CN (4)