- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07624461
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Post-Exposure Prophylaxis Outcome of Zamerovimab and Mazorelvimab Injection and Rabies Vaccine in Grade III Rabies Exposure Cases From Single-Dog Multiple-Bite Incidents: A Real-World Prospective Study
The objective of this real-world, prospective observational study is to evaluate the clinical effectiveness of zamerovimab and mazorelvimab injection (a human rabies monoclonal antibody cocktail) administered in combination with a standard rabies vaccine for post-exposure prophylaxis (PEP) in individuals with WHO Grade III rabies exposure in Nanyang City, China.
- The study primarily aims to assess:
- The 3-month rabies-free survival rate following PEP initiation.
- The 1-year long-term rabies-free survival rate.
The rabies virus (RABV) carrying rate and genomic epidemiology among offending dogs involved in single-dog multiple-bite incidents.
Eligible participants aged 18 years or older who have sustained a Grade III exposure from a tracked multi-person canine attack event, and have completed wound debridement and initial passive/active immunization within 24 hours prior to screening, will be followed for up to 1 year via telephone or clinic visits to monitor clinical survival.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Henan
-
Nanyang, Henan, Kina, 473000
- The Disease Prevention and Control Center of Nanyang
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Adults aged ≥18 years at the time of screening.
- Sustained a verified WHO Grade III rabies exposure from a traceable offending dog involved in a multi-person canine attack incident (defined as a single animal attacking multiple individuals within a clustered timeframe/location) in Nanyang City.
- Time interval from Grade III exposure to post-exposure prophylaxis (PEP) initiation is less than 7 days.
- Successfully completed standard wound debridement, anatomical infiltration of zamerovimab/mazorelvimab injection (0.3 mg/kg single full dose), and the first dose of rabies vaccine within 24 hours prior to screening.
- Voluntarily provides signed written informed consent.
- Patient is willing and able to comply with all sequential follow-up procedures (including serum collections if applicable) and intends to reside locally for the full 1-year study duration.
Exclusion Criteria:
- Documented history of any separate animal bite or scratch (e.g., dog, cat, bat, or wild carnivore) within the past 12 months prior to the current exposure.
- Documented complete pre-exposure or post-exposure rabies vaccination history within the past 12 months.
- Concurrent presentation with life-threatening traumatic injuries requiring intensive care, or severe systemic immunodeficiency disorders that could impede immunogenicity or follow-up compliance.
- Any other clinical or psychological condition deemed by the investigator as unsuitable for safe participation or reliable data registry.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Grade III rabies exposure cohort
Adults (≥18 years) who sustained verified WHO Grade III rabies exposure from a traceable dog involved in a tracked multi-person attack incident, and who initiated standardized PEP within the protocolized window.
|
Standard-of-care wound debridement, followed by anatomical infiltration of zamerovimab/mazorelvimab injection at a single dose of 0.3 mg/kg around the wound sites on Day 0, combined with a standard intramuscular rabies vaccine regimen.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
3-month rabies-free survival rate
Tidsram: 90 days (±3 days) post-enrollment
|
The proportion of participants alive and free of clinical rabies symptoms at 90 days following post-exposure prophylaxis (PEP) initiation.
|
90 days (±3 days) post-enrollment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1-year rabies-free survival rate
Tidsram: 365 days (±7 days) post-enrollment
|
The proportion of participants alive and free of clinical rabies symptoms at 1 year following post-exposure prophylaxis (PEP) initiation.
|
365 days (±7 days) post-enrollment
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SYN023-RWE-001
Plan för individuella deltagardata (IPD)
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