Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

Sponsor
Beijing Tiantan Hospital
Study ID
NCT07311343
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hemorrhage
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Dec 30, 2025
Start date
Jan 7, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: enhanced oral care combined with prophylactic antibiotics
    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.
  • Experimental: conventional standard treatment combined with conventional oral care
    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.

Primary Outcome Measure

The occurrence of pneumonia related to cerebral hemorrhage [ Time Frame: From enrollment to the 10th day after randomization or at the time of discharge ]

Central Contacts

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