HSV EncephalitisNCT05127395
Impact of Obesity on Clinical Outcomes in Patients Receiving Acyclovir for HSV Encephalitis"
An observational study of HSV Encephalitis, run by Methodist Health System at 1 site in United States.
Trial summary
Multicenter retrospective chart review of patients admitted to any of the six study centers (SSM Health - St. Clare, St. Mary's, Saint Louis University Hospital, St. Anthony's, St. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HSV Encephalitis
- What is being tested?
- To assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis to definitively guide safe and effective therapy.
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 12 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * More than one dosing weight strategy utilized for > 24 hours for IV acyclovir dosing during the index admission * Patients transferred to the hospital already on IV acyclovir for HSV encephalitis * ESRD on admission * Concomitant pathogen causing meningitis or encephalitis * Oral acyclovir used for treatment
Who may be able to join
- Patients Admitted to a SSM Health - St. Clare (STL), St. Mary's (STL), Saint Louis University Hospital (STL), St. Anthony's (OKC), St. Mary's Madison (WIS), Rush University Medical Center (RUMC), or Methodist Dallas Medical Center
- > 18 years old
- Positive cerebrospinal fluid (CSF) PCR for HSV-1 or HSV-2
- BMI > 30 kg/m2
- Received guideline-approved, weight-based doses of IV acyclovir for HSV encephalitis for at least 72 hours during the index admission
- Received appropriately renal dose-adjusted doses of IV acyclovir per package insert recommendations
Who cannot join
- More than one dosing weight strategy utilized for > 24 hours for IV acyclovir dosing during the index admission
- Patients transferred to the hospital already on IV acyclovir for HSV encephalitis
- ESRD on admission
- Concomitant pathogen causing meningitis or encephalitis
- Oral acyclovir used for treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Charlton Medical Center
Dallas, Texas, 75237
About this study
Official title: Impact of Dosing Weight on Clinical Outcomes in Obese Patients Receiving Acyclovir for HSV Encephalitis (ID-OPRAH)
Multicenter retrospective chart review of patients admitted to any of the six study centers (SSM Health - St. Clare, St. Mary's, Saint Louis University Hospital, St. Anthony's, St. Mary's Madison, Rush University Medical Center, or Methodist Dallas Medical Center) between January 1, 2013 and December 31, 2019 will be conducted. All study centers utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis.
Read the detailed description
- Obese - WHO definition: Body Mass Index > 30 kg/m2
- Ideal Body Weight (IBW) (male) - 50.0 kg + 2.3 kg x (patient height in inches, above 60 inches)
- Ideal Body Weight (female) - 45.5 kg + 2.3 kg x (patient height inches, above 60 inches)
- Adjusted Body Weight - IBW + [0.4 x (ABW - IBW)]
- HSV encephalitis - PCR positive for HSV-1 or HSV-2 in CSF during index admission
- Baseline Serum Creatinine (S Cr) - The SCr value obtained before the start of acyclovir therapy on which the dose of acyclovir should be based upon
- Acute Kidney Injury (AKI) - per RIFLE criteria and while receiving acyclovir: SCr doubles or urine output < 0.5 mL/kg/hour for 12 hours
- End-stage renal disease (ESRD) on admission - mention of a diagnosis of ESRD in electronic medical records prior to receipt of acyclovir
- Guideline-approved, weight-based doses - within 10% of 10 mg/kg dose (to account for rounding due to vial size)
- Adequate hydration - IV fluid order (other than KVO [keep vein open]) within 24 hours before acyclovir start AND either IV fluid order (other than KVO) for majority of acyclovir course or IV fluid + oral diet for majority of acyclovir course
- Appropriately renally dose-adjusted doses - Frequency of acyclovir matches package insert recommendations based on creatinine clearance at baseline
- Interacting medications - Mycophenolate, probenecid, zidovudine, tenofovir, valproic acid, phenytoin
- Conditions
- HSV Encephalitis
- Being tested
- To assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis to definitively guide safe and effective therapy.
- Medical subject headings
- Encephalitis, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis to definitively guide safe and effective therapy.Other
The study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Will assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis
Measured: Over 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start9 Mar 2021
- Primary completion21 Feb 2023
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSV EncephalitisStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Crotty, PharmD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127395
- Sponsor's protocol ID
- 007.PHA.2020.A
- Status last verified
- Jul 2023
- First submitted
- 9 Nov 2021
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dosing Weight on Clinical Outcomes in Obese Patients Receiving Acyclovir for HSV Encephalitis (ID-OPRAH)
- ClinicalTrials.gov ID
- NCT05127395
- Acronym / sponsor ID
- 007.PHA.2020.A
- Conditions
- HSV Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 19 Nov 2021 (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.
Multicenter retrospective chart review of patients admitted to any of the six study centers (SSM Health - St. Clare, St. Mary's, Saint Louis University Hospital, St. Anthony's, St. Mary's Madison, Rush University Medical Center, or Methodist Dallas Medical Center) between January 1, 2013 and December 31, 2019 will be conducted. All study centers utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis.
Detailed description
- Obese - WHO definition: Body Mass Index > 30 kg/m2
- Ideal Body Weight (IBW) (male) - 50.0 kg + 2.3 kg x (patient height in inches, above 60 inches)
- Ideal Body Weight (female) - 45.5 kg + 2.3 kg x (patient height inches, above 60 inches)
- Adjusted Body Weight - IBW + [0.4 x (ABW - IBW)]
- HSV encephalitis - PCR positive for HSV-1 or HSV-2 in CSF during index admission
- Baseline Serum Creatinine (S Cr) - The SCr value obtained before the start of acyclovir therapy on which the dose of acyclovir should be based upon
- Acute Kidney Injury (AKI) - per RIFLE criteria and while receiving acyclovir: SCr doubles or urine output < 0.5 mL/kg/hour for 12 hours
- End-stage renal disease (ESRD) on admission - mention of a diagnosis of ESRD in electronic medical records prior to receipt of acyclovir
- Guideline-approved, weight-based doses - within 10% of 10 mg/kg dose (to account for rounding due to vial size)
- Adequate hydration - IV fluid order (other than KVO [keep vein open]) within 24 hours before acyclovir start AND either IV fluid order (other than KVO) for majority of acyclovir course or IV fluid + oral diet for majority of acyclovir course
- Appropriately renally dose-adjusted doses - Frequency of acyclovir matches package insert recommendations based on creatinine clearance at baseline
- Interacting medications - Mycophenolate, probenecid, zidovudine, tenofovir, valproic acid, phenytoin
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * More than one dosing weight strategy utilized for > 24 hours for IV acyclovir dosing during the index admission * Patients transferred to the hospital already on IV acyclovir for HSV encephalitis * ESRD on admission * Concomitant pathogen causing meningitis or encephalitis * Oral acyclovir used for treatment
Key inclusion criteria (6 listed)
- Patients Admitted to a SSM Health - St. Clare (STL), St. Mary's (STL), Saint Louis University Hospital (STL), St. Anthony's (OKC), St. Mary's Madison (WIS), Rush University Medical Center (RUMC), or Methodist Dallas Medical Center
- > 18 years old
- Positive cerebrospinal fluid (CSF) PCR for HSV-1 or HSV-2
- BMI > 30 kg/m2
- Received guideline-approved, weight-based doses of IV acyclovir for HSV encephalitis for at least 72 hours during the index admission
Key exclusion criteria (5 listed)
- More than one dosing weight strategy utilized for > 24 hours for IV acyclovir dosing during the index admission
- Patients transferred to the hospital already on IV acyclovir for HSV encephalitis
- ESRD on admission
- Concomitant pathogen causing meningitis or encephalitis
- Oral acyclovir used for treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis to definitively guide safe and effective therapy.The study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from. Each study center will obtain individual IRB approval prior to data collection. SSM - St. Clare will serve as the lead center for the study with all other centers sending collected and de-identified data to this central site for analysis. | Other | – |
Primary outcome
In-hospital mortality
Time frame: Over 1 month
Will assess the clinical impact of dosing acyclovir based on IBW or adjBW for HSV encephalitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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.
Matthew Crotty, PharmD principal investigator
The Methodist Hospital Research Institute
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 HSV Encephalitis, run by Methodist Health System at 1 site in United States.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 Mar 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: Over 1 month). 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 23 Mar 2026.