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Determination of Voriconazole Plasma Concentration by HPLC Technique and Evaluating Its Association with Clinical Outcome and Adverse Effects in Patients with Invasive Aspergillosis

Protocol summary

Study aim
Determination of Voriconazole Plasma Concentration by high performance liquid chromatography (HPLC) Technique and Evaluating Its Association with Clinical Outcome and Adverse Effects in Patients with Invasive Aspergillosis
Design
This is a clinical trial which was performed on 24 patients with invasive aspergillosis and were eligible for inclusion in the study.
Settings and conduct
This study was done in Dr. Masih Daneshvari Hopital. For all patients, sex, age, weight, route of administration, underlying diseases, clinical outcome, adverse effects, and lab test were recorded. For each patient, plasma sample were collected under steady-state condition and analyzed using a validated high performance liquid chromatography method.
Participants/Inclusion and exclusion criteria
Patients 18 years old and older who initiated the oral or intravenous voriconazole for possible, probable or proven invasive aspergillosis were included in the study. Exclusion criteria were history of allergy or severe reaction to azoles; aspergilloma or allergic bronchopulmonary aspergillosis; concomitant use of carbamazepine, efavirenz, rifampin, sirolimus or Ergot alkaloids; chronic invasive aspergillosis with duration of symptoms for more than 4 weeks; severe liver dysfunction (total bilirubin, , alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) more than 3 times the upper limit of normal); and receiving combination of antifungal therapy.
Intervention groups
Voriconazole was administered as a loading dose of 6 mg per Kg two times daily and maintenance dose of 4 mg per Kg two times daily.
Main outcome variables
Voriconazole plasma concentration, adverse effects, and outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151227025726N19
Registration date: 2020-06-16, 1399/03/27
Registration timing: retrospective

Last update: 2020-06-16, 1399/03/27
Update count: 0
Registration date
2020-06-16, 1399/03/27
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
2017-12-21, 1396/09/30
Actual recruitment end date
2019-02-19, 1397/11/30
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Determination of Voriconazole Plasma Concentration by HPLC Technique and Evaluating Its Association with Clinical Outcome and Adverse Effects in Patients with Invasive Aspergillosis
Public title
Therapeutic Drug Monitoring of Voriconazole
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the age of 18 years and older Patients who were initiated on oral or intravenous voriconazole for proven, probable, or possible invasive aspergillosis
Exclusion criteria:
History of allergy or severe reaction to azoles Aspergilloma or allergic bronchopulmonary aspergillosis Concomitant use of carbamazepine, efavirenz, rifampin, sirolimus or Ergot alkaloids Chronic invasive aspergillosis with duration of symptoms for more than 4 weeks Severe liver dysfunction (total bilirubin, , alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) more than 3 times the upper limit of normal) Receiving combination of antifungal therapy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of School of Pharmacy, Nursing, and Midwifery; Shahid Beheshti University of Medica
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.SBMU.PHNM.1396.886

Health conditions studied

1

Description of health condition studied
Invasive pulmonary aspergillosis
ICD-10 code
B44.0
ICD-10 code description
Invasive pulmonary aspergillosis

Primary outcomes

1

Description
Voriconazole plasma level
Timepoint
Minimum three days after voriconazole administration (at the time of steady-state)
Method of measurement
High performance liquid chromatography

2

Description
Evaluation of treatment success
Timepoint
7 and 14 days after treatment and at end of the study
Method of measurement
The evaluation of treatment as partial or complete success was based on clinical (fever, signs and symptoms of infection, and inflammatory markers) and radiological (CT or MRI findings) improvement or eradication of the fungal pathogen.

3

Description
Evaluation of treatment failure
Timepoint
7 and 14 days after treatment and at end of the study
Method of measurement
Failure to treatment was defined by persistent fungal infection after more than 14 days of treatment or by progressing fungal infection defined by clinical and radiological progression, persistently positive culture results, or death due to fungal infection after more than 7 days of treatment.

Secondary outcomes

1

Description
Adverse drug reaction
Timepoint
Daily
Method of measurement
Observation and lab tests evaluation

2

Description
Death
Timepoint
At end of the study
Method of measurement
Medical Record

Intervention groups

1

Description
Intervention group: Voriconazole was administered as a loading dose of 6 mg per Kg two times daily and maintenance dose of 4 mg per Kg two times daily. For each patient, plasma sample were collected under steady-state condition and analyzed using a validated high performance liquid chromatography method.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Daar-Abad, Shahid Bahonar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
fzh.dastan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Doctor of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Phone
+98 21 8820 0118
Email
saahar26@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assistant professor, Clinical Pharmacy specialist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Phone
+98 21 8820 0118
Email
fzh.dastan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yousefian
Position
Doctor of Pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
6153- 14155
Phone
+98 21 8820 0118
Email
saahar26@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All potential data can be shared after blinding
When the data will become available and for how long
Six months after results publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. Farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document
Official letter to the researchers
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