Preventing pneumonia after brain hemorrhage with extra mouth care and preventive antibiotics

Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

This will test whether enhanced oral hygiene combined with preventive antibiotics can help adults who recently had a spontaneous intracerebral hemorrhage avoid pneumonia.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 440 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07311343 on ClinicalTrials.gov

What this trial studies

This is a randomized, controlled, open-label trial with blinded endpoint assessment comparing enhanced oral hygiene plus prophylactic antibiotics to usual care in adults with recent spontaneous supratentorial intracerebral hemorrhage. Eligible patients are enrolled within 72 hours of symptom onset, have hematoma volume under 30 ml and a higher risk score for stroke-associated pneumonia. The trial measures whether the combined intervention reduces the incidence of post-hemorrhage pneumonia, monitors safety outcomes, and analyzes health-economic effects. Treatment is delivered in-hospital with planned follow-up to capture infections, adverse events, and resource use.

Who should consider this trial

Good fit: Adults 18–80 years with spontaneous supratentorial intracerebral hemorrhage within 72 hours, hematoma volume <30 ml, GCS ≥9, ICH-APS ≥8, and able to give informed consent are ideal candidates.

Not a fit: Patients with secondary causes of hemorrhage (for example aneurysm, tumor, venous thrombosis), signs of brain herniation, obvious pneumonia at enrollment, or other major exclusion criteria are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce post-ICH pneumonia rates, shorten hospital stays, and improve recovery for patients.

How similar studies have performed: Similar enhanced oral care programs and selective antibiotic approaches have reduced pneumonia in some stroke and ICU populations, but combining enhanced oral hygiene with routine prophylactic antibiotics specifically after intracerebral hemorrhage is less well established and prior results have been mixed.

Eligibility criteria

Inclusion Criteria:

1. Age 18-80 years old;
2. Spontaneous intracerebral hemorrhage;
3. Supratentorial intracerebral hemorrhage (ICH);
4. Hematoma volume \< 30 ml (calculated by ABC/2 method);
5. Glasgow Coma Scale score ≥ 9 at randomization;
6. Time from onset to randomization ≤ 72 hours;
7. Spontaneous intracerebral hemorrhage-associated pneumonia score (ICH-APS) ≥ 8;
8. Informed consent from the patient and/or their family.

Exclusion Criteria:

1. 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.
2. 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.
3. 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℃.
4. 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.
5. 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.
6. Severe renal insufficiency: such as patients undergoing dialysis, or diagnosed with severe active kidney disease, etc., or creatinine clearance rate \< 50 mL/min.
7. Other severe diseases that lead to an expected lifespan of less than 1 year.
8. 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.
9. Patients unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, emotional disorders, etc.
10. Pregnant or lactating women.
11. Participation in other clinical studies within 3 months or currently participating in other clinical studies.
12. Known allergy to cephalosporins, penicillins, or chlorhexidine compound mouthwash.

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Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Junping Guo — Beijing Tiantan Hospital
• Study coordinator: Xue Sun

Conditions Hemorrhage; Pneumonia; Cerebral hemorrhage; Stroke Associated Pneumonia; oral care; prophylactic antibiotics; effectiveness