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Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Xue Sun
sunxue1110@163.com
86+13521769614
Backup
Qixuan Guan
g15510280866@foxmail.com
86+18612572388
Time Frame
Start Date: 2026-01-07
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 440
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov