Actively Recruiting
Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
Led by Beijing Tiantan Hospital · Updated on 2026-02-12
440
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Project Name: Randomized Controlled Clinical Study on oral hygiene and prophylactic antibiotics to prevent Intracerebral Hemorrhage associated pneumonia Research Objectives: To evaluate the effectiveness, safety and health economics value of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 1. To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 2. To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 3. To clarify the health economics value of low-intensity enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. Research Design: Research Type: Multicenter, Randomized, Controlled, Open Label, Blinded Endpoint Research Design Research Hypothesis: Intensive oral hygiene combined with antibiotic treatment is beneficial in reducing the incidence of pulmonary infections related to cerebral hemorrhage.
CONDITIONS
Official Title
Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Diagnosed with spontaneous intracerebral hemorrhage
- Supratentorial intracerebral hemorrhage location
- Hematoma volume less than 30 ml (measured by ABC/2 method)
- Glasgow Coma Scale score of 9 or higher at randomization
- Time from hemorrhage onset to randomization within 72 hours
- Intracerebral hemorrhage-associated pneumonia score (ICH-APS) of 8 or higher
- Informed consent obtained from patient or family
You will not qualify if you...
- Secondary intracerebral hemorrhage caused by aneurysms, arteriovenous malformations, tumors, venous thrombosis, antithrombotic therapy, hemorrhagic transformation after infarction, or blood disorders
- Signs of brain herniation such as worsening consciousness or absent pupillary reflex
- Existing pneumonia signs including fever, persistent cough, yellow sputum, or chest imaging indicating pneumonia
- Severe cardiovascular disease including advanced heart failure, recent unstable angina, treated arrhythmias, significant QTc prolongation, heart blocks requiring treatment, recent myocardial infarction, or high-risk chronic arrhythmias
- Severe active liver disease or liver enzyme levels more than three times normal
- Severe kidney disease including dialysis or creatinine clearance below 50 mL/min
- Other severe illnesses with life expectancy under one year
- Planned surgery before first treatment including hematoma evacuation or decompressive procedures
- Mental illness or cognitive impairment preventing understanding or follow-up
- Pregnancy or breastfeeding
- Participation in other clinical studies within the past three months
- Known allergies to cephalosporins, penicillins, or chlorhexidine mouthwash
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
X
Xue Sun
CONTACT
Q
Qixuan Guan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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