Testing mouth care with antibiotics to prevent pneumonia after brain bleeding
Tests enhanced mouth care with antibiotics in adults aged 18 to 80 with brain bleeding.
Plain-language title generated from the registry record
Registry title: Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-80 with a recent bleed inside the brain (spontaneous intracerebral hemorrhage). It tests extra mouth care plus antibiotics to prevent pneumonia.
- Age
- 18 to 80 years
- Sex
- All sexes can join.
- Disease stage
- Spontaneous bleed in the upper part of the brain (supratentorial). Blood clot smaller than 30 ml. Glasgow Coma Scale score of 9 or more. No more than 72 hours from onset to randomization. Pneumonia risk score (ICH-APS) of 8 or more.
- Earlier treatment
- No surgery planned before the first dose, such as clot removal, decompressive craniectomy or external ventricular drainage. No other clinical study within 3 months.
Main reasons for not taking part
- Bleed caused by another problem, such as an aneurysm, tumor, blood disease or blood-thinning medicine
- Signs of brain herniation or pneumonia already present
- Severe heart, liver or kidney disease, including dialysis
- Pregnant or breastfeeding women
- Known allergy to cephalosporins, penicillins or chlorhexidine mouthwash
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07311343, who can take part
Where in China
- Beijing Tiantan HospitalBeijing, ChinaContact: Junping GuoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT07311343
- Record updated
- 12 February 2026
- Original description
Project Name:Read full original descriptionShow less
Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
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.
Inclusion: Age 18-80 years old; Spontaneous intracerebral hemorrhage; Supratentorial intracerebral hemorrhage (ICH); Hematoma volume < 30 ml (calculated by ABC/2 method); Glasgow Coma Scale score ≥ 9 at randomization; Time from onset to randomization ≤ 72 hours; Spontaneous intracerebral hemorrhage-associated pneumonia score (ICH-APS) ≥ 8; Informed consent from the patient and/or their family.
Exclusion: Patients scheduled for surgical intervention before the first administration, including but not limited to hematoma evacuation (including minimally invasive and conventional surgery), decompressive craniectomy, hematoma aspiration, and external ventricular drainage; Secondary intracerebral hemorrhage, such as that resulting from cerebral aneurysms, cerebral arteriovenous malformations, brain tumors, cerebral venous system thrombosis, antithrombotic therapy (antiplatelet, anticoagulant therapy, etc.), hemorrhagic transformation after cerebral infarction, hematological diseases, etc; Other severe diseases that lead to an expected lifespan of less than 1 year; Patients unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, emotional disorders, etc; Known allergy to cephalosporins, penicillins, or chlorhexidine compound mouthwash; -; A history of severe cardiovascular disease, meeting any of the following: 1) Heart failure (New York Heart Association functional class ≥ III); 2) Unstable angina within 3 months; 3) Any supraventricular or ventricular arrhythmia requiring treatment; 4) Prolonged QTc interval considered clinically significant by the investigator (reference range: > 450ms for men, > 470ms for women) (Note: QTc interval must be calculated according to Fridericia's formula); 5) Complete atrioventricular block and left or right bundle branch block requiring treatment; 6) Acute myocardial infarction or interventional treatment within 1 month; high-risk patients with chronic arrhythmia, such as sick sinus syndrome, second or third-degree atrioventricular block, bradycardia-related syncope without pacemaker installation, etc; Diagnosed with severe active liver disease, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc.; or ALT or AST > 3 times the upper limit of normal; Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, etc., or creatinine clearance rate < 50 mL/min; The patient's clinical symptoms and signs suggest signs of brain herniation, such as progressive decline in consciousness level, weakened or absent pupillary light reflex; Obvious signs of pneumonia already exist, such as fever, persistent cough or yellow purulent sputum, and imaging examinations (chest X-ray or chest CT) suggest signs of pneumonia; two consecutive measurements of body temperature ≥ 37.5℃, or one measurement of body temperature ≥ 38.0℃; Pregnant or lactating women; Participation in other clinical studies within 3 months or currently participating in other clinical studies.