Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

NCT07311343 | Recruiting Phase 4 DMC

• 1 other identifier: KY2025-105-03
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
2. 2.To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
3. 3.To clarify the health economics value of low-intensity enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.

Conditions

Hemorrhage; Pneumonia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The occurrence of pneumonia related to cerebral hemorrhage

  The occurrence of pneumonia related to cerebral hemorrhage

  From enrollment to the 10th day after randomization or at the time of discharge

Secondary Outcomes (5)

• urinary tract infection or other systemic infection

  From enrollment to the 10th day after randomization or at discharge

• Improvement in neurological dysfunction (NIHSS10d-NIHSS group)

  From enrollment to the 10th day after randomization or at discharge

• Length of hospital stay

  From hospital admission until discharge (anticipated average 7-10 days)

• direct medical expenses during hospitalization

  From hospital admission until discharge (anticipated average 7-10 days)

• Modified Rankin Scale score

  From enrollment to the 90 days ± 7 days after randomization

Study Arms (2)

enhanced oral care combined with prophylactic antibiotics

ACTIVE COMPARATOR

After randomization, immediate intensive oral hygiene treatment (chlorhexidine 20ml, three times a day) combined with antibiotics (ceftazidime 1g, every 8 hours) was given on the basis of conventional standard treatment, and the treatment course was 3 days.

Biological: wether apply enhanced oral care combined with prophylactic antibiotics

conventional standard treatment combined with conventional oral care

EXPERIMENTAL

Conventional standard treatment combined with routine oral care (20 ml of normal saline twice a day), and detailed records were made of the specific measures of the patients' oral care, including the selection of the cleaning solution and the frequency.

Biological: wether apply enhanced oral care combined with prophylactic antibiotics

Interventions

wether apply enhanced oral care combined with prophylactic antibiotics BIOLOGICAL

Intervention group: After randomization, immediate intensive oral hygiene treatment (chlorhexidine 20 ml, three times a day) combined with antibiotics (ceftazidime 1 g, every 8 hours) was administered on the basis of the conventional standard treatment, and the treatment lasted for 3 days; Control group: Conventional standard treatment combined with routine oral care (normal saline 20 ml, twice a day), and detailed records were made of the specific measures of patient oral care, including the selection of cleaning solution and frequency.

conventional standard treatment combined with conventional oral care; enhanced oral care combined with prophylactic antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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℃.
• 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.
• Other severe diseases that lead to an expected lifespan of less than 1 year.
• 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.
• Patients unable to understand the research procedures and/or complete follow-up due to mental illness, cognitive impairment, emotional disorders, etc.
• Pregnant or lactating women.
• Participation in other clinical studies within 3 months or currently participating in other clinical studies.
• Known allergy to cephalosporins, penicillins, or chlorhexidine compound mouthwash.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Hemorrhage; Pneumonia; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Junping Guo

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xue Sun

CONTACT

86+13521769614; sunxue1110@163.com

Qixuan Guan

CONTACT

86+18612572388; g15510280866@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nurse

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 30, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)