Voriconazole Induced QT Interval ProlongationNCT04502355
Voriconazole-Induced QT Interval Prolongation: A Prospective Study
An observational study of Voriconazole Induced QT Interval Prolongation, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Voriconazole Induced QT Interval Prolongation
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Oct 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- Child, Adult
Study population: Children aged 0-20 years treated with oral or IV voriconazole at the Schneider Children's Medical Center from Oct 31st 2016.
Who may be able to join
- oral or IV treatment with voriconazole
Who cannot join
- No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
- Renal insufficiency or dialysis treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider childrens medical center of Isreal
Petah Tikva
Odelia Matz, +972-54-4634718, odeliama1@clalit.org.il
Liat Ashkenazi-Hoffnung, MD, +972-54-4749345, liata3@clalit.org.il
About this study
The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.
- Keywords
- voriconazole, ECG, arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
QT interval prolongation
Measured: up to three months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start31 Oct 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voriconazole Induced QT Interval ProlongationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502355
- Sponsor's protocol ID
- 0483-16-RMC
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voriconazole-Induced QT Interval Prolongation: A Prospective Study
- ClinicalTrials.gov ID
- NCT04502355
- Acronym / sponsor ID
- 0483-16-RMC
- Keywords
- voriconazole, ECG, arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children aged 0-20 years treated with oral or IV voriconazole at the Schneider Children's Medical Center from Oct 31st 2016.
Key inclusion criteria (1 listed)
- oral or IV treatment with voriconazole
Key exclusion criteria (2 listed)
- No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
- Renal insufficiency or dialysis treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QT interval prolongation
Time frame: up to three months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Schneider childrens medical center of Isreal
Petah Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voriconazole Induced QT Interval Prolongation, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT interval prolongation (time frame: up to three months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.