RabiesNCT04213950
Improving Adherence to Rabies PEP Guideline Recommendations
A study testing Rabies PEP quality improvement bundle in people with Rabies and Rabies Human, run by The Methodist Hospital Research Institute at 15 sites in United States.
Trial summary
This quasi-experimental, quality improvement study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rabies, Rabies Human, Rabies Virus Infection
- What is being tested?
- Rabies PEP quality improvement bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 15 sitesUnited States
- Study dates
- 29 Dec 2019to 23 Dec 2020
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Houston Methodist Emergency Department at Baytown
Baytown, Texas, 77521
Houston Methodist Emergency Care Center in Cypress
Cypress, Texas, 77433
Houston Methodist Hospital Emergency Department
Houston, Texas, 77030
Houston Methodist Emergency Care Center at Voss
Houston, Texas, 77057
Houston Methodist Emergency Department at Willowbrook Hospital
Houston, Texas, 77070
Houston Methodist Emergency Department at West
Houston, Texas, 77094
Houston Methodist Emergency Care Center at Kirby
Houston, Texas, 77098
Houston Methodist Emergency Care Center in Sienna Plantation
Missouri City, Texas, 77459
Houston Methodist Emergency Department at Clear Lake
Nassau Bay, Texas, 77058
Houston Methodist Emergency Care Center in Pearland
Pearland, Texas, 77584
Houston Methodist Emergency Care Center in Cinco Ranch
Richmond, Texas, 77406
Houston Methodist Emergency Care Center in Spring
Spring, Texas, 77388
Houston Methodist Emergency Department at Sugar Land
Sugar Land, Texas, 77479
Houston Methodist Emergency Care Center in The Woodlands
The Woodlands, Texas, 77384
Houston Methodist Emergency Department at The Woodlands
The Woodlands, Texas, 77385
About this study
Official title: Improving Adherence to Rabies Postexposure Prophylaxis Guideline Recommendations for Rabies Immune Globulin at a Multi-hospital Health System Through Education, Collaboration, and Clinical Decision Support
This quasi-experimental, quality improvement study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED). Previous research identified opportunities to improve patient selection and delivery of rabies immune globulin (IG) as recommended by Centers for Disease Control and Prevention (CDC) guideline recommendations for rabies postexposure prophylaxis (PEP). The purpose of this study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) rabies PEP electronic health records (EHR) enhancements, (2) education to ED staff, and (3) education to patients. Adherence to quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG for 12 months following implementation (post-implementation group) will be compared with a historical control group.
Read the detailed description
BACKGROUND: Rabies infection can occur in humans when key elements of the rabies PEP regimens are omitted or incorrectly administered. The CDC Advisory Committee on Immunization Practices (ACIP) recommends that patients who are exposed to rabies virus should receive prompt and thorough wound cleansing followed by administration of human rabies IG and rabies vaccine. Previous research identified three opportunities to improve adherence to CDC guideline recommendations for rabies PEP: (1) infiltration of rabies IG into and around the wounds, if anatomically feasible, (2) administration of rabies IG at an anatomical site distant from rabies vaccine administration, and (3) avoiding administration of rabies IG into the buttock.
STUDY DESIGN: This quasi-experimental, quality improvement study evaluates adherence to 6 quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG before and after implementation of the rabies PEP quality improvement bundle. The quality improvement bundle includes EHR enhancements, ED staff education, and patient education. Patients who receive at least one dose of rabies IG or rabies vaccine at a study site during the study period will be included in this study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 12 months following bundle implementation. The primary outcome is full adherence to all 6 quality indicators for rabies IG selection and delivery.
- Conditions
- Rabies, Rabies Human, Rabies Virus Infection
- Being tested
- Rabies PEP quality improvement bundle
- Keywords
- rabies immune globulin, rabies vaccine, rabies postexposure prophylaxis, rabies PEP, rabies IG
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabies PEP quality improvement bundleOther
The rabies PEP quality improvement bundle consists of (1) electronic health record enhancements to support rabies PEP treatment selection, administration, and discharge process; (2) education to ED staff on rabies PEP; and (3) education to patients on rabies PEP and follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Post-implementation group | Experimental | The post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle. Receives: Other: Rabies PEP quality improvement bundle |
| Historical control group | No intervention | The historical control group received care prior to implementation of the quality improvement bundle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery
The proportion of patients who achieve full adherence to a composite of all 6 quality indicators for rabies IG patient selection and delivery: (1) appropriate patient selection, (2) appropriate dose, (3) appropriate timing, (4) administration into and around the wound if anatomically feasible, (5) administration distant from rabies vaccine, and (6) administration that avoids the buttock (unless the wound is near the buttock) among patients who received rabies PEP.
Measured: 1 day; during the patient's first medical encounter at a study site for rabies PEP
Secondary outcomes (5)
Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery
The proportion of patients who achieve adherence to each of the 6 quality indicators for rabies IG patient selection and delivery.
Measured: 1 day; during the patient's first medical encounter at a study site for rabies PEP
Volume of rabies immune globulin administered into or around wounds
The mean percent of the total volume of rabies IG administered into or around wounds, if anatomically feasible.
Measured: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Clear documentation of rabies immune globulin administration site
The proportion of patients with clear EHR documentation of rabies IG administration sites
Measured: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Incidence of compartment syndrome
The incidence of compartment syndrome at a rabies IG infiltration site that was documented in the EHR within 7 days of rabies IG administration
Measured: For 7 days following rabies IG administration
Incidence of sciatic nerve injury
The incidence of sciatic nerve injury that was documented in the EHR within 21 days of rabies IG administration among patients who receive rabies IG into the buttock
Measured: For 21 days following rabies IG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start29 Dec 2019
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes patients who received rabies PEP from January 2015 to June 2018. The quality improvement bundle will be implemented across the Houston Methodist health system in December 2019. The post-implementation group includes patients who receive rabies PEP within 12 months following bundle implementation. An estimated sample size of 70 patients in the post-implementation group and 254 patients in the historical control group will provide 80% power to detect an absolute increase of 20% in the primary endpoint using a two-sided alpha of 0.05.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Responsible party
- Principal investigator, Joshua Swan, PharmD, MPH, FCCM, The Methodist Hospital Research Institute
- Investigators
- Joshua Swan, PharmD, MPH, Principal investigator, Houston Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213950
- Sponsor's protocol ID
- Pro00022539
- Status last verified
- Aug 2021
- First submitted
- 23 Dec 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hwang GS, Rizk E, Bui LN, Iso T, Sartain EI, Tran AT, Swan JT. Adherence to guideline recommendations for human rabies immune globulin patient selection, dosing, timing, and anatomical site of administration in rabies postexposure prophylaxis. Hum Vaccin Immunother. 2020;16(1):51-60. doi: 10.1080/21645515.2019.1632680. Epub 2019 Aug 1.
PubMed 31210569Rupprecht CE, Briggs D, Brown CM, Franka R, Katz SL, Kerr HD, Lett SM, Levis R, Meltzer MI, Schaffner W, Cieslak PR; Centers for Disease Control and Prevention (CDC). Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep. 2010 Mar 19;59(RR-2):1-9.
PubMed 20300058Bharti OK, Madhusudana SN, Gaunta PL, Belludi AY. Local infiltration of rabies immunoglobulins without systemic intramuscular administration: An alternative cost effective approach for passive immunization against rabies. Hum Vaccin Immunother. 2016 Mar 3;12(3):837-42. doi: 10.1080/21645515.2015.1085142.
PubMed 26317441Bharti OK, Madhusudana SN, Wilde H. Injecting rabies immunoglobulin (RIG) into wounds only: A significant saving of lives and costly RIG. Hum Vaccin Immunother. 2017 Apr 3;13(4):762-765. doi: 10.1080/21645515.2016.1255834. Epub 2017 Feb 22.
PubMed 28277089Wilde H, Sirikawin S, Sabcharoen A, Kingnate D, Tantawichien T, Harischandra PA, Chaiyabutr N, de Silva DG, Fernando L, Liyanage JB, Sitprija V. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996 Feb;22(2):228-32. doi: 10.1093/clinids/22.2.228.
PubMed 8838177Madhusudana SN, Aggarwal P, Tripathi KK. Failure of rabies postexposure treatment with purified chick embryo cell (PCEC) vaccine. Vaccine. 1989 Oct;7(5):478-9. doi: 10.1016/0264-410x(89)90185-0. No abstract available.
PubMed 2815983Jung Kim H, Hyun Park S. Sciatic nerve injection injury. J Int Med Res. 2014 Aug;42(4):887-97. doi: 10.1177/0300060514531924. Epub 2014 Jun 11.
PubMed 24920643National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64.
PubMed 21293327HyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.
Salva EP, Dimaano EM, Villarama JB, Suquilla JT. An evaluation of the safety and potency of equine rabies immunoglobulin through measurements of suppression on vaccine induced antibody production among healthy volunteers. Philippine Journal of Internal Medicine. 2014;52(2):1-7.
HyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.
Kline DG, Kim D, Midha R, Harsh C, Tiel R. Management and results of sciatic nerve injuries: a 24-year experience. J Neurosurg. 1998 Jul;89(1):13-23. doi: 10.3171/jns.1998.89.1.0013.
PubMed 9647167GILLES FH, FRENCH JH. Postinjection sciatic nerve palsies in infants and children. J Pediatr. 1961 Feb;58:195-204. doi: 10.1016/s0022-3476(61)80158-3. No abstract available.
PubMed 13705320Bergeson PS, Singer SA, Kaplan AM. Intramuscular injections in children. Pediatrics. 1982 Dec;70(6):944-8.
PubMed 6755373Centers for Disease Control and Prevention. Human Rabies. 2017; https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html. Accessed Jan 10, 2019.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Rabies Postexposure Prophylaxis Guideline Recommendations for Rabies Immune Globulin at a Multi-hospital Health System Through Education, Collaboration, and Clinical Decision Support
- ClinicalTrials.gov ID
- NCT04213950
- Acronym / sponsor ID
- Pro00022539
- Conditions
- Rabies, Rabies Human, Rabies Virus Infection
- Keywords
- rabies immune globulin, rabies vaccine, rabies postexposure prophylaxis, rabies PEP, rabies IG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Grifols Biologicals, LLC
- Study start
- 29 Dec 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 30 Dec 2019 (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.
This quasi-experimental, quality improvement study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED). Previous research identified opportunities to improve patient selection and delivery of rabies immune globulin (IG) as recommended by Centers for Disease Control and Prevention (CDC) guideline recommendations for rabies postexposure prophylaxis (PEP). The purpose of this study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) rabies PEP electronic health records (EHR) enhancements, (2) education to ED staff, and (3) education to patients. Adherence to quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG for 12 months following implementation (post-implementation group) will be compared with a historical control group.
Detailed description
BACKGROUND: Rabies infection can occur in humans when key elements of the rabies PEP regimens are omitted or incorrectly administered. The CDC Advisory Committee on Immunization Practices (ACIP) recommends that patients who are exposed to rabies virus should receive prompt and thorough wound cleansing followed by administration of human rabies IG and rabies vaccine. Previous research identified three opportunities to improve adherence to CDC guideline recommendations for rabies PEP: (1) infiltration of rabies IG into and around the wounds, if anatomically feasible, (2) administration of rabies IG at an anatomical site distant from rabies vaccine administration, and (3) avoiding administration of rabies IG into the buttock.
STUDY DESIGN: This quasi-experimental, quality improvement study evaluates adherence to 6 quality indicators, which are based on CDC guideline recommendations, for patient selection and delivery of rabies IG before and after implementation of the rabies PEP quality improvement bundle. The quality improvement bundle includes EHR enhancements, ED staff education, and patient education. Patients who receive at least one dose of rabies IG or rabies vaccine at a study site during the study period will be included in this study. The historical control group includes patients treated prior to bundle implementation. The post-implementation group includes patients treated within 12 months following bundle implementation. The primary outcome is full adherence to all 6 quality indicators for rabies IG selection and delivery.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of 2 groups: (1) the historical control group and (2) the post-implementation group. The historical control group includes patients who received rabies PEP from January 2015 to June 2018. The quality improvement bundle will be implemented across the Houston Methodist health system in December 2019. The post-implementation group includes patients who receive rabies PEP within 12 months following bundle implementation. An estimated sample size of 70 patients in the post-implementation group and 254 patients in the historical control group will provide 80% power to detect an absolute increase of 20% in the primary endpoint using a two-sided alpha of 0.05.
| Arm | Type | Receives |
|---|---|---|
| Post-implementation group | Experimental | Other: Rabies PEP quality improvement bundleThe post-implementation group will receive care that is enhanced by the rabies PEP quality improvement bundle. |
| Historical control group | No intervention | –The historical control group received care prior to implementation of the quality improvement bundle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Receive at least one dose of rabies IG or rabies vaccine at a study site during the study period
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Rabies PEP quality improvement bundleThe rabies PEP quality improvement bundle consists of (1) electronic health record enhancements to support rabies PEP treatment selection, administration, and discharge process; (2) education to ED staff on rabies PEP; and (3) education to patients on rabies PEP and follow-up care. | Other | Post-implementation group |
Primary outcome
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery
Time frame: 1 day; during the patient's first medical encounter at a study site for rabies PEP
The proportion of patients who achieve full adherence to a composite of all 6 quality indicators for rabies IG patient selection and delivery: (1) appropriate patient selection, (2) appropriate dose, (3) appropriate timing, (4) administration into and around the wound if anatomically feasible, (5) administration distant from rabies vaccine, and (6) administration that avoids the buttock (unless the wound is near the buttock) among patients who received rabies PEP.
5 secondary outcomes
Adherence to each of the 6 quality indicators for rabies immune globulin patient selection and delivery
Time frame: 1 day; during the patient's first medical encounter at a study site for rabies PEP
Volume of rabies immune globulin administered into or around wounds
Time frame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Clear documentation of rabies immune globulin administration site
Time frame: 1 day; during the patient's first medical encounter at a study site where rabies IG is administered
Incidence of compartment syndrome
Time frame: For 7 days following rabies IG administration
Incidence of sciatic nerve injury
Time frame: For 21 days following rabies IG administration
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 5 Sep 2021.
- Background: PubMed 31210569Hwang GS, Rizk E, Bui LN, Iso T, Sartain EI, Tran AT, Swan JT. Adherence to guideline recommendations for human rabies immune globulin patient selection, dosing, timing, and anatomical site of administration in rabies postexposure prophylaxis. Hum Vaccin Immunother. 2020;16(1):51-60. doi: 10.1080/21645515.2019.1632680. Epub 2019 Aug 1.
- Background: PubMed 20300058Rupprecht CE, Briggs D, Brown CM, Franka R, Katz SL, Kerr HD, Lett SM, Levis R, Meltzer MI, Schaffner W, Cieslak PR; Centers for Disease Control and Prevention (CDC). Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep. 2010 Mar 19;59(RR-2):1-9.
- Background: PubMed 26317441Bharti OK, Madhusudana SN, Gaunta PL, Belludi AY. Local infiltration of rabies immunoglobulins without systemic intramuscular administration: An alternative cost effective approach for passive immunization against rabies. Hum Vaccin Immunother. 2016 Mar 3;12(3):837-42. doi: 10.1080/21645515.2015.1085142.
- Background: PubMed 28277089Bharti OK, Madhusudana SN, Wilde H. Injecting rabies immunoglobulin (RIG) into wounds only: A significant saving of lives and costly RIG. Hum Vaccin Immunother. 2017 Apr 3;13(4):762-765. doi: 10.1080/21645515.2016.1255834. Epub 2017 Feb 22.
- Background: PubMed 8838177Wilde H, Sirikawin S, Sabcharoen A, Kingnate D, Tantawichien T, Harischandra PA, Chaiyabutr N, de Silva DG, Fernando L, Liyanage JB, Sitprija V. Failure of postexposure treatment of rabies in children. Clin Infect Dis. 1996 Feb;22(2):228-32. doi: 10.1093/clinids/22.2.228.
- Background: PubMed 2815983Madhusudana SN, Aggarwal P, Tripathi KK. Failure of rabies postexposure treatment with purified chick embryo cell (PCEC) vaccine. Vaccine. 1989 Oct;7(5):478-9. doi: 10.1016/0264-410x(89)90185-0. No abstract available.
- Background: PubMed 24920643Jung Kim H, Hyun Park S. Sciatic nerve injection injury. J Int Med Res. 2014 Aug;42(4):887-97. doi: 10.1177/0300060514531924. Epub 2014 Jun 11.
- Background: PubMed 21293327National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64.
- BackgroundHyperRab® [rabies immune globulin (human)] [package insert]. Grifols Therapeutics Inc., Research Triangle Park, NC, USA. 2018.
- BackgroundSalva EP, Dimaano EM, Villarama JB, Suquilla JT. An evaluation of the safety and potency of equine rabies immunoglobulin through measurements of suppression on vaccine induced antibody production among healthy volunteers. Philippine Journal of Internal Medicine. 2014;52(2):1-7.
- BackgroundHyperRab® S/D (rabies immune globulin [human]) [package insert]. Grifols Therapeutics Inc., Clayton, NC. 2012.
- Background: PubMed 9647167Kline DG, Kim D, Midha R, Harsh C, Tiel R. Management and results of sciatic nerve injuries: a 24-year experience. J Neurosurg. 1998 Jul;89(1):13-23. doi: 10.3171/jns.1998.89.1.0013.
- Individual participant dataSharing planned: No
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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.
Joshua Swan, PharmD, MPH principal investigator
Houston Methodist Health System
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabies PEP quality improvement bundle in people with Rabies and Rabies Human, run by The Methodist Hospital Research Institute at 15 sites 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 1 inclusion and 0 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Full adherence to 6 quality indicators for rabies immune globulin patient selection and delivery (time frame: 1 day; during the patient's first medical encounter at a study site for rabies PEP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04213950, which also lists 15 linked publications.
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 5 Sep 2021.