HemorrhagePhase 4OCEANNCT07311343
Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
A Phase 4 study testing wether apply enhanced oral care combined with prophylactic antibiotics in people with Hemorrhage and Pneumonia, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhage, Pneumonia
- What is being tested?
- wether apply enhanced oral care combined with prophylactic antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100000
Junping Guo, 86+13621091361, guojunpingttyy@163.com
About this study
Project Name:
Randomized Controlled Clinical Study on oral hygiene and prophylactic antibiotics to prevent Intracerebral Hemorrhage associated pneumonia
Read more
Research Objectives:
To evaluate the effectiveness, safety and health economics value of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
- To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
- To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
- 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.
Read the detailed description
Research Background:
The era of evidence-based medicine has been entered. For acute ischemic stroke within the 4.5-hour time window, intravenous thrombolysis, mechanical thrombectomy within 24 hours of onset, and stroke units all have clear evidence-based medical support for their intervention methods. However, for cerebral hemorrhage, which has higher disability and mortality rates, treatment methods currently lack evidence-based medical support, with management more often being supportive. In this context, exploring new targets, methods, and strategies to improve the prognosis of cerebrovascular diseases has become a hot topic in global research.
Stroke-associated pneumonia (SAP) is one of the most common complications after stroke. Substantial evidence shows that the occurrence of SAP not only increases patient length of hospital stay and medical expenses but also significantly elevates the risk of death and severe disability post-stroke. Based on data from the China National Stroke Registry (CNSR), the composition and distribution of various complications after cerebral infarction and cerebral hemorrhage in Chinese patients were first systematically reported. Among them, SAP is the most common complication for both major stroke subtypes: cerebral infarction and cerebral hemorrhage. Concurrently, it was also found that SAP not only increases the risk of adverse stroke prognosis but is also an important risk factor for the increase of various non-pneumonia complications. For example, in the sub-cohort of acute cerebral infarction patients (N=14,702), the occurrence of SAP increased the risk of gastrointestinal bleeding by 8-fold (adjusted OR=8.35; 95% CI=6.27-11.1; P<0.001), pressure ulcers by 5-fold (OR=5.31; 95% CI=3.39-8.31; P<0.001), deep vein thrombosis by 4-fold (OR=4.27; 95% CI=2.41-7.59; P<0.001), symptomatic epilepsy by 4-fold (OR=3.96; 95% CI=2.67-5.88; P<0.001), urinary tract infection by 3-fold (OR=3.34; 95% CI=2.73-4.10; P<0.001), atrial fibrillation by 3-fold (OR=3.17; 95% CI=2.58-3.90; P<0.001), and stroke recurrence by 2-fold (OR=2.65; 95% CI=2.07-3.40; P<0.001).
The same phenomenon was also confirmed in the cerebral hemorrhage cohort (N=5,221). The effective prevention and control of SAP will become a new target for improving stroke prognosis, as clearly reflected in multiple domestic and international expert consensuses and guidelines on SAP.
Similar related studies have been conducted abroad. In 2015, the UK STROKE-INF study, for patients hospitalized within 48 hours after stroke onset, administered prophylactic antibiotics for 7 days plus standard stroke ward care or standard stroke ward care alone, finally including 1,217 patients from 37 units (615 in the antibiotic group, 602 in the control group). No difference was found in the diagnosis of post-stroke pneumonia between the two groups (101 of 615 patients [16%] in the antibiotic treatment group vs. 91 of 602 patients [15%] in the non-antibiotic treatment group; adjusted OR = 1.01 [95% CI 0.61-1.68], p = 0.957). In 2015, the Dutch PASS study randomly assigned acute stroke patients in a 1:1 ratio to an antibiotic treatment group (ceftriaxone) or a non-antibiotic treatment group (control) within 24 hours after onset. The control group received standardized stroke treatment; the ceftriaxone group received standardized treatment plus intravenous application of 2g ceftriaxone once daily for 4 days. Finally, 2,538 patients were included for treatment analysis (ceftriaxone group: 1,268; control group: 1,270). The study results showed that prophylactic use of ceftriaxone was safe, mainly manifested by a significantly lower incidence of urinary tract infections in the ceftriaxone group, with no significant difference in the incidence of infections at other sites between the two groups. Prophylactic ceftriaxone did not affect the distribution of 3-month modified Rankin Scale (mRS) scores (OR = 0.95 [95% CI 0.81-1.09], p = 0.46). Both these trials yielded negative results. This study aims to explore the relationship between the preventive use of antibiotics combined with oral care and the incidence of SAP in the Chinese population.
Research Objectives:
To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
To clarify the health economics value of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
- Conditions
- Hemorrhage, Pneumonia
- Being tested
- wether apply enhanced oral care combined with prophylactic antibiotics
- Keywords
- Cerebral hemorrhage, Stroke Associated Pneumonia, oral care, prophylactic antibiotics, effectiveness
- Medical subject headings
- Hemorrhage, Pneumonia, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wether apply enhanced oral care combined with prophylactic antibioticsBiological
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: wether apply enhanced oral care combined with prophylactic antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of pneumonia related to cerebral hemorrhage
The occurrence of pneumonia related to cerebral hemorrhage
Measured: From enrollment to the 10th day after randomization or at the time of discharge
Secondary outcomes (5)
urinary tract infection or other systemic infection
urinary tract infection or other systemic infection
Measured: From enrollment to the 10th day after randomization or at discharge
Improvement in neurological dysfunction (NIHSS10d-NIHSS group)
This study used the difference between the NIH Stroke Scale (NIHSS, 0-42) score on the 10th day after randomization or at discharge and the NIHSS score (0-42) at the time of enrollment to represent the change in neurological dysfunction (NIHSS10d-NIHSS group). The smaller the difference, or even a negative value, the better the improvement in neurological dysfunction. Conversely, the larger the difference, the worse the improvement.
Measured: From enrollment to the 10th day after randomization or at discharge
Length of hospital stay
The period from the patient's admission to the patient's discharge.It is the date of discharge minus the date of admission
Measured: From hospital admission until discharge (anticipated average 7-10 days)
direct medical expenses during hospitalization
The direct expenses incurred by the patient during the hospitalization period.
Measured: From hospital admission until discharge (anticipated average 7-10 days)
Modified Rankin Scale score
This study used the Modified Rankin Scale (mRS，0-6) score at 90 ± 7 days after randomization to reflect the long-term prognosis of the patients. The higher the score, the worse the prognosis. Conversely, the lower the score, the better the prognosis.
Measured: From enrollment to the 90 days ± 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start7 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guojunping, Beijing Tiantan Hospital
- Investigators
- Junping Guo, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311343
- Sponsor's protocol ID
- KY2025-105-03
- Acronym
- OCEAN
- Status last verified
- Sep 2025
- First submitted
- 26 Nov 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
PubMed 25612858Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
PubMed 26343840Vernino S, Brown RD Jr, Sejvar JJ, Sicks JD, Petty GW, O'Fallon WM. Cause-specific mortality after first cerebral infarction: a population-based study. Stroke. 2003 Aug;34(8):1828-32. doi: 10.1161/01.STR.0000080534.98416.A0. Epub 2003 Jul 10.
PubMed 12855836Saposnik G, Hill MD, O'Donnell M, Fang J, Hachinski V, Kapral MK; Registry of the Canadian Stroke Network for the Stroke Outcome Research Canada (SORCan) Working Group. Variables associated with 7-day, 30-day, and 1-year fatality after ischemic stroke. Stroke. 2008 Aug;39(8):2318-24. doi: 10.1161/STROKEAHA.107.510362. Epub 2008 Jun 19.
PubMed 18566303Katzan IL, Dawson NV, Thomas CL, Votruba ME, Cebul RD. The cost of pneumonia after acute stroke. Neurology. 2007 May 29;68(22):1938-43. doi: 10.1212/01.wnl.0000263187.08969.45.
PubMed 17536051Ingeman A, Andersen G, Hundborg HH, Svendsen ML, Johnsen SP. In-hospital medical complications, length of stay, and mortality among stroke unit patients. Stroke. 2011 Nov;42(11):3214-8. doi: 10.1161/STROKEAHA.110.610881. Epub 2011 Aug 25.
PubMed 21868737Ji R, Wang D, Shen H, Pan Y, Liu G, Wang P, Wang Y, Li H, Wang Y; China National Stroke Registry (CNSR) Investigators. Interrelationship among common medical complications after acute stroke: pneumonia plays an important role. Stroke. 2013 Dec;44(12):3436-44. doi: 10.1161/STROKEAHA.113.001931. Epub 2013 Oct 31.
PubMed 24178914Kumar S, Selim MH, Caplan LR. Medical complications after stroke. Lancet Neurol. 2010 Jan;9(1):105-18. doi: 10.1016/S1474-4422(09)70266-2.
PubMed 20083041Badve MS, Zhou Z, van de Beek D, Anderson CS, Hackett ML. Frequency of post-stroke pneumonia: Systematic review and meta-analysis of observational studies. Int J Stroke. 2019 Feb;14(2):125-136. doi: 10.1177/1747493018806196. Epub 2018 Oct 22.
PubMed 30346258Steiner T, Al-Shahi Salman R, Beer R, Christensen H, Cordonnier C, Csiba L, Forsting M, Harnof S, Klijn CJ, Krieger D, Mendelow AD, Molina C, Montaner J, Overgaard K, Petersson J, Roine RO, Schmutzhard E, Schwerdtfeger K, Stapf C, Tatlisumak T, Thomas BM, Toni D, Unterberg A, Wagner M; European Stroke Organisation. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage. Int J Stroke. 2014 Oct;9(7):840-55. doi: 10.1111/ijs.12309. Epub 2014 Aug 24.
PubMed 25156220Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
PubMed 26022637Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
PubMed 31662037Wang W, Jiang B, Sun H, Ru X, Sun D, Wang L, Wang L, Jiang Y, Li Y, Wang Y, Chen Z, Wu S, Zhang Y, Wang D, Wang Y, Feigin VL; NESS-China Investigators. Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults. Circulation. 2017 Feb 21;135(8):759-771. doi: 10.1161/CIRCULATIONAHA.116.025250. Epub 2017 Jan 4.
PubMed 28052979GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.
PubMed 27291521
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia
- ClinicalTrials.gov ID
- NCT07311343
- Acronym / sponsor ID
- OCEAN / KY2025-105-03
- Conditions
- Hemorrhage, Pneumonia
- Keywords
- Cerebral hemorrhage, Stroke Associated Pneumonia, oral care, prophylactic antibiotics, effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
- To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia.
- 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.
Detailed description
Research Background:
The era of evidence-based medicine has been entered. For acute ischemic stroke within the 4.5-hour time window, intravenous thrombolysis, mechanical thrombectomy within 24 hours of onset, and stroke units all have clear evidence-based medical support for their intervention methods. However, for cerebral hemorrhage, which has higher disability and mortality rates, treatment methods currently lack evidence-based medical support, with management more often being supportive. In this context, exploring new targets, methods, and strategies to improve the prognosis of cerebrovascular diseases has become a hot topic in global research.
Stroke-associated pneumonia (SAP) is one of the most common complications after stroke. Substantial evidence shows that the occurrence of SAP not only increases patient length of hospital stay and medical expenses but also significantly elevates the risk of death and severe disability post-stroke. Based on data from the China National Stroke Registry (CNSR), the composition and distribution of various complications after cerebral infarction and cerebral hemorrhage in Chinese patients were first systematically reported. Among them, SAP is the most common complication for both major stroke subtypes: cerebral infarction and cerebral hemorrhage. Concurrently, it was also found that SAP not only increases the risk of adverse stroke prognosis but is also an important risk factor for the increase of various non-pneumonia complications. For example, in the sub-cohort of acute cerebral infarction patients (N=14,702), the occurrence of SAP increased the risk of gastrointestinal bleeding by 8-fold (adjusted OR=8.35; 95% CI=6.27-11.1; P<0.001), pressure ulcers by 5-fold (OR=5.31; 95% CI=3.39-8.31; P<0.001), deep vein thrombosis by 4-fold (OR=4.27; 95% CI=2.41-7.59; P<0.001), symptomatic epilepsy by 4-fold (OR=3.96; 95% CI=2.67-5.88; P<0.001), urinary tract infection by 3-fold (OR=3.34; 95% CI=2.73-4.10; P<0.001), atrial fibrillation by 3-fold (OR=3.17; 95% CI=2.58-3.90; P<0.001), and stroke recurrence by 2-fold (OR=2.65; 95% CI=2.07-3.40; P<0.001).
The same phenomenon was also confirmed in the cerebral hemorrhage cohort (N=5,221). The effective prevention and control of SAP will become a new target for improving stroke prognosis, as clearly reflected in multiple domestic and international expert consensuses and guidelines on SAP.
Similar related studies have been conducted abroad. In 2015, the UK STROKE-INF study, for patients hospitalized within 48 hours after stroke onset, administered prophylactic antibiotics for 7 days plus standard stroke ward care or standard stroke ward care alone, finally including 1,217 patients from 37 units (615 in the antibiotic group, 602 in the control group). No difference was found in the diagnosis of post-stroke pneumonia between the two groups (101 of 615 patients [16%] in the antibiotic treatment group vs. 91 of 602 patients [15%] in the non-antibiotic treatment group; adjusted OR = 1.01 [95% CI 0.61-1.68], p = 0.957). In 2015, the Dutch PASS study randomly assigned acute stroke patients in a 1:1 ratio to an antibiotic treatment group (ceftriaxone) or a non-antibiotic treatment group (control) within 24 hours after onset. The control group received standardized stroke treatment; the ceftriaxone group received standardized treatment plus intravenous application of 2g ceftriaxone once daily for 4 days. Finally, 2,538 patients were included for treatment analysis (ceftriaxone group: 1,268; control group: 1,270). The study results showed that prophylactic use of ceftriaxone was safe, mainly manifested by a significantly lower incidence of urinary tract infections in the ceftriaxone group, with no significant difference in the incidence of infections at other sites between the two groups. Prophylactic ceftriaxone did not affect the distribution of 3-month modified Rankin Scale (mRS) scores (OR = 0.95 [95% CI 0.81-1.09], p = 0.46). Both these trials yielded negative results. This study aims to explore the relationship between the preventive use of antibiotics combined with oral care and the incidence of SAP in the Chinese population.
Research Objectives:
To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
To clarify the health economics value of enhanced oral hygiene combined with antibiotics in preventing pneumonia after cerebral hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enhanced oral care combined with prophylactic antibiotics | Active comparator | Biological: wether apply enhanced oral care combined with prophylactic antibioticsAfter 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. |
| conventional standard treatment combined with conventional oral care | Experimental | Biological: wether apply enhanced oral care combined with prophylactic antibioticsConventional 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wether apply enhanced oral care combined with prophylactic antibioticsIntervention 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. | Biological | conventional standard treatment combined with conventional oral care, enhanced oral care combined with prophylactic antibiotics |
Primary outcome
The occurrence of pneumonia related to cerebral hemorrhage
Time frame: From enrollment to the 10th day after randomization or at the time of discharge
The occurrence of pneumonia related to cerebral hemorrhage
5 secondary outcomes
urinary tract infection or other systemic infection
Time frame: From enrollment to the 10th day after randomization or at discharge
Improvement in neurological dysfunction (NIHSS10d-NIHSS group)
Time frame: From enrollment to the 10th day after randomization or at discharge
Length of hospital stay
Time frame: From hospital admission until discharge (anticipated average 7-10 days)
direct medical expenses during hospitalization
Time frame: From hospital admission until discharge (anticipated average 7-10 days)
Modified Rankin Scale score
Time frame: From enrollment to the 90 days ± 7 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 25612858Westendorp WF, Vermeij JD, Zock E, Hooijenga IJ, Kruyt ND, Bosboom HJ, Kwa VI, Weisfelt M, Remmers MJ, ten Houten R, Schreuder AH, Vermeer SE, van Dijk EJ, Dippel DW, Dijkgraaf MG, Spanjaard L, Vermeulen M, van der Poll T, Prins JM, Vermeij FH, Roos YB, Kleyweg RP, Kerkhoff H, Brouwer MC, Zwinderman AH, van de Beek D, Nederkoorn PJ; PASS investigators. The Preventive Antibiotics in Stroke Study (PASS): a pragmatic randomised open-label masked endpoint clinical trial. Lancet. 2015 Apr 18;385(9977):1519-26. doi: 10.1016/S0140-6736(14)62456-9. Epub 2015 Jan 20.
- Background: PubMed 26343840Kalra L, Irshad S, Hodsoll J, Simpson M, Gulliford M, Smithard D, Patel A, Rebollo-Mesa I; STROKE-INF Investigators. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial. Lancet. 2015 Nov 7;386(10006):1835-44. doi: 10.1016/S0140-6736(15)00126-9. Epub 2015 Sep 3.
- Background: PubMed 12855836Vernino S, Brown RD Jr, Sejvar JJ, Sicks JD, Petty GW, O'Fallon WM. Cause-specific mortality after first cerebral infarction: a population-based study. Stroke. 2003 Aug;34(8):1828-32. doi: 10.1161/01.STR.0000080534.98416.A0. Epub 2003 Jul 10.
- Background: PubMed 18566303Saposnik G, Hill MD, O'Donnell M, Fang J, Hachinski V, Kapral MK; Registry of the Canadian Stroke Network for the Stroke Outcome Research Canada (SORCan) Working Group. Variables associated with 7-day, 30-day, and 1-year fatality after ischemic stroke. Stroke. 2008 Aug;39(8):2318-24. doi: 10.1161/STROKEAHA.107.510362. Epub 2008 Jun 19.
- Background: PubMed 17536051Katzan IL, Dawson NV, Thomas CL, Votruba ME, Cebul RD. The cost of pneumonia after acute stroke. Neurology. 2007 May 29;68(22):1938-43. doi: 10.1212/01.wnl.0000263187.08969.45.
- Background: PubMed 21868737Ingeman A, Andersen G, Hundborg HH, Svendsen ML, Johnsen SP. In-hospital medical complications, length of stay, and mortality among stroke unit patients. Stroke. 2011 Nov;42(11):3214-8. doi: 10.1161/STROKEAHA.110.610881. Epub 2011 Aug 25.
- Background: PubMed 24178914Ji R, Wang D, Shen H, Pan Y, Liu G, Wang P, Wang Y, Li H, Wang Y; China National Stroke Registry (CNSR) Investigators. Interrelationship among common medical complications after acute stroke: pneumonia plays an important role. Stroke. 2013 Dec;44(12):3436-44. doi: 10.1161/STROKEAHA.113.001931. Epub 2013 Oct 31.
- Background: PubMed 20083041Kumar S, Selim MH, Caplan LR. Medical complications after stroke. Lancet Neurol. 2010 Jan;9(1):105-18. doi: 10.1016/S1474-4422(09)70266-2.
- Background: PubMed 30346258Badve MS, Zhou Z, van de Beek D, Anderson CS, Hackett ML. Frequency of post-stroke pneumonia: Systematic review and meta-analysis of observational studies. Int J Stroke. 2019 Feb;14(2):125-136. doi: 10.1177/1747493018806196. Epub 2018 Oct 22.
- Background: PubMed 25156220Steiner T, Al-Shahi Salman R, Beer R, Christensen H, Cordonnier C, Csiba L, Forsting M, Harnof S, Klijn CJ, Krieger D, Mendelow AD, Molina C, Montaner J, Overgaard K, Petersson J, Roine RO, Schmutzhard E, Schwerdtfeger K, Stapf C, Tatlisumak T, Thomas BM, Toni D, Unterberg A, Wagner M; European Stroke Organisation. European Stroke Organisation (ESO) guidelines for the management of spontaneous intracerebral hemorrhage. Int J Stroke. 2014 Oct;9(7):840-55. doi: 10.1111/ijs.12309. Epub 2014 Aug 24.
- Background: PubMed 26022637Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.
- Background: PubMed 31662037Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junping Guo principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing wether apply enhanced oral care combined with prophylactic antibiotics in people with Hemorrhage and Pneumonia, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Sun (86+13521769614, sunxue1110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07311343, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.