Administrative information
Title {1} | Efficacy and safety of voriconazole in the treatment of invasive pulmonary aspergillosis in patients with liver failure: study protocol for a randomized controlled clinical trial |
Trial registration {2a and 2b} | The trial was registered with the Chinese Clinical Trial Registry, ChiCTR2100048259. Registered on 5 July 2021 |
Protocol version {3} | Date:2021.11.30 Version identifier: 1.0 |
Funding {4} | This study was supported by China International Medical Foundation (grant number: Z-2018–35-2003) and Clinical Research Foundation of the 3rd Affiliated Hospital of Sun Yat-sen University(grant number: YHJH201904) |
Author details {5a} | Xue Yu1,#, Lejia Xu2,#, Jiaxing Zheng1, Ziying Lei1, Yihua Pang1, Xiaojie Li3, Jianyun Zhu1,*, Jing Liu1,* Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe Road, Guangzhou city, Guangdong province, China, 510630 Department of Pharmacy, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe Road, Guangzhou city, Guangdong province, China, 510630 Department of Laboratory Medicine, Third Affiliated Hospital of Sun Yat-Sen University, 600# Tianhe Road, Guangzhou city, Guangdong province, China, 510630 #Xue Yu and Lejia Xu shared the first authorship *Co-corresponding authors |
Name and contact information for the trial sponsor {5b} | China International Medical Foundation 42 Dongsi Xidajie, Beijing, 100710 Tel:86–10-85158267 Fax:86–10-65266642 |
Role of sponsor {5c} | The funder was not involved in trial design, conduct, or reporting All authors (Xue Yu, Lejia Xu, Jiaxing Zheng, Ziying Lei, Yihua Pang, Xiaojie Li, Jianyun Zhu, Jing Liu) were involved in the conceptualization and design of the trial, made significant intellectual contributions to the written protocol, and have approved the submitted version |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Dropout criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
Participant timeline {13}
Viewpoint | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 |
---|---|---|---|---|---|---|---|---|---|---|---|
Time point | 0 (baseline) | 12 h | 24 h | 48 h | 72 h | Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
Use of voriconazole | Before treatment | Before the 2nd dose | Before the 3rd dose | Before the 5th dose | Before the 7th dose | Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
Time-window | − 7 | 0 | 0 | 0 | 0 | ± 1 | ± 2 | ± 2 | ± 2 | ± 3 | ± 3 |
Informed consent | √ | ||||||||||
Essential information | √ | ||||||||||
Inclusion/exclusion criteria | √ | ||||||||||
Previous treatments | √ | ||||||||||
Previous medicine | √ | ||||||||||
CYP2C19 gene | √ | ||||||||||
Symptoms | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Physical sign | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Comorbidity | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
ECG | √ | ||||||||||
Lung CT | √ | √ | √ | √ | √ | ||||||
Abdominal ultrasonography | √ | √ | √ | ||||||||
Blood routine | √ | √ | √ | √ | √ | √ | √ | √ | |||
Renal function | √ | √ | √ | ||||||||
Inflammation indicators | √ | √ | √ | √ | √ | √ | √ | √ | |||
G/GM test | √ | √ | √ | √ | √ | √ | √ | ||||
BALF culture or histopathology | √ | ||||||||||
Biochemical test | √ | √ | √ | √ | √ | √ | √ | √ | |||
Coagulation function | √ | √ | √ | √ | √ | √ | √ | √ | |||
ABG | √ | √ | √ | √ | √ | √ | √ | √ | |||
Blood ammonia | √ | √ | √ | √ | √ | √ | √ | √ | |||
Pregnancy test (female) | √ | ||||||||||
Plasma voriconazole trough concentration | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
Concomitant medication | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
Child–Pugh classification | √ | √ | √ | √ | √ | √ | √ | ||||
MELD score | √ | √ | √ | √ | √ | √ | √ | ||||
Condition evaluation | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | |
AE | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |
SAE | √ | √ | √ | √ | √ | √ | √ | √ | √ | √ |