NCT02100761

Brief Summary

To investigate the relationship between cytochrome P450 (CYP) 2C19 genetic polymorphism and the steady-state blood concentration of voriconazole in Chinese patients with invasive pulmonary aspergillosis (IPA), and to assess the effects of voriconazole trough concentration on the prognosis of IPA patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 1, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 3, 2014

Last Update Submit

March 31, 2014

Conditions

Invasive Pulmonary Aspergillosis

Keywords

VoriconazoleInvasive pulmonary aspergillosisTherapeutic drug monitoringCYP genetic polymorphismEfficacySafety

Outcome Measures

Primary Outcomes (1)

  • voriconazole trough level

    one year

Secondary Outcomes (1)

  • Overall mortality

    one year

Study Arms (1)

invasive pulmonary aspergillosis

Patients with invasive pulmonary aspergillosis and will be treated with voriconazole according to their physician decision in five hospital, Jinan, China

Drug: Voriconazole

Interventions

VoriconazoleDRUG

Patients with creatinine clearance at least 50 ml/min will be treated with voriconazole by intravenous drip infusion at the dose of 6 mg/kg twice daily on the first day (Day 1) and 4 mg/kg twice daily from day 2 onward. The IV treatment is at least 7 days. Then switch to 200 mg orally twice daily between meals. The total treatment duration is at least 14 days Patients with creatinine clearance \<50 ml/min will be treated with oral voriconazole (loading dose of 400 mg twice daily followed by maintenance dose of 200 mg twice daily between meals for at least 14.0 days).

Also known as: Voriconazole Intravenous Solution 200 mg, Voriconazole Tablet 50 mg / Voriconazole Tablet 200 mg
invasive pulmonary aspergillosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with invasive pulmonary aspergillosis and will be treated with voriconazole according to their physician decision

You may qualify if:

  • Proven, probable, or possible invasive pulmonary aspergillosis (IPA)
  • Acute IPA defined as duration of clinical syndrome of \<30 days.
  • Treatment with voriconazole
  • At least 18 years and older
  • Weight \>40 kg and ≤120 kg
  • Given the informed consent

You may not qualify if:

  • Patients allergic to azole(s)
  • Patients who heve been prescribed voriconazole before
  • Positive urine pregnancy test (if female)
  • Patients with aspergilloma or chronic aspergillosis ( \>1 month duration )
  • Anticipated survival of less than 5 days or Karnofsky score \<=20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital

Jinan, Shandong, 250012, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

The susceptibility test of aspergillosis strains to voriconazole, serum galactomannan (GM) test, voriconazole trough levels and genotyping of CYP2C19 will be measured.

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsLung Diseases, FungalLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shifang Ding, Ph.D.

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Shifang Ding, Ph.D.

CONTACT

18560081003dingshifang@sdu.edu.cn

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

April 1, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 1, 2014

Record last verified: 2014-03

Locations

CN(1)