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הניסוי הקליני NCT07495150 (FLAME) עבור Blood-Brain Barrier, דלקת קרום המוח חיידקית הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן.
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תצוגת כרטיסים
חזרה לחיפוש

Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis (FLAME) 86

טרם החל גיוס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07495150 (FLAME) הוא מחקר מסוג התערבותי עבור Blood-Brain Barrier, דלקת קרום המוח חיידקית, שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 באפריל 2026, במטרה לכלול 86 משתתפים. המחקר ינוהל על ידי yilong Wang וצפוי להסתיים ב-1 ביולי 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 במרץ 2026.
סיכום קצר
Multiple preclinical and clinical studies, including the investigators' published work and the ongoing SOLUTION series, have consistently demonstrated that intracalvariosseous (ICO) injection can markedly increase drug exposure within the central nervous system with acceptable safety. This trial is designed to further evaluate the efficacy and safety of antibiotic delivery via the ICO route in the treatment of bacter...הצג עוד
תיאור מפורט
Bacterial meningitis remains a major cause of death and neurological disability despite advances in antimicrobial therapy, vaccination, and critical care. Moderate-to-severe disease, particularly healthcare-associated infection and cases caused by multidrug-resistant pathogens, continues to pose substantial therapeutic challenges because intravenous antibiotic therapy alone may not achieve sufficiently rapid or susta...הצג עוד
כותרת רשמית

Efficacy and Safety of Intracalvariosseous Combined With Intravenous Injection of Antibiotics in Moderate-to-Severe Bacterial Meningitis

מצבים רפואיים
Blood-Brain Barrierדלקת קרום המוח חיידקית
מזהי מחקר נוספים
  • FLAME
  • CX25YZ07
מספר NCT
NCT07495150
תחילת המחקר (בפועל)
2026-04-01
עדכון אחרון שפורסם
2026-03-27
סיום המחקר (מוערך)
2027-07-01
משתתפים (מתוכנן)
86
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מילות מפתח
Blood-Brain Barrier
Bacterial meningitis
Prognosis
Intracalvariosseous
Antibiotic
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
יחיד
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיIntracalvariosseous injection + Intravenous injection
In patients who fail to respond to the initial intravenous antibiotic regimen, intravenous treatment will be switched to the indicated antibiotic (polymyxin B, tigecycline, or vancomycin). At the same time, bilateral parietal outer-table drill holes will be created, delivery devices will be secured, and the corresponding antibiotic will be continuously infused via the intracalvariosseous route. The combined ICO and i...הצג עוד
Intracalvariosseous injection vancomycin/tigecycline/polymyxin B
Continuous intracalvariosseous infusion of polymyxin B (12.5 mg/day), tigecycline (12.5 mg/day), and vancomycin (125 mg/day).
Intravenous injection vancomycin/tigecycline/polymyxin B
Intravenous infusion of polymyxin B (100 mg/day), tigecycline (100 mg/day), and vancomycin (2000 mg/day).
טיפול קונבנציונלי
Standard treatment and management according to related guidelines during the entire treatment period
משווה פעילIntravenous injection
In patients who fail to respond to the initial intravenous antibiotic regimen, intravenous treatment will be switched to the indicated antibiotic (polymyxin B, tigecycline, or vancomycin). The duration of intravenous therapy will be adjusted according to treatment response, including clinical symptoms, signs, and laboratory findings.
Intravenous injection vancomycin/tigecycline/polymyxin B
Intravenous infusion of polymyxin B (100 mg/day), tigecycline (100 mg/day), and vancomycin (2000 mg/day).
טיפול קונבנציונלי
Standard treatment and management according to related guidelines during the entire treatment period
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Overall effective rate after 7 days of randomization
Overall effective rate = \[(Cure + Improvement) / Total Number of Case\] \* 100% Cure: Cerebrospinal fluid (CSF) white blood cell count, CSF protein concentration, CSF/serum glucose ratio, and CSF bacterial culture are all normal in three consecutive tests. Improvement: At least one of the following three CSF white blood cell counts, CSF protein concentration, CSF/serum glucose ratio, and CSF bacterial culture is normal. Ineffective: All three of the following CSF white blood cell counts, CSF protein concentration, CSF/serum glucose ratio, and CSF bacterial culture are abnormal. Normal Reference Values for CSF Indicators: white blood cell count \< 100 × 10⁶/L, protein concentration \< 50 mg/dL, CSF/serum glucose ratio \> 0.5.
8,10 and 14 days after randomization
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Cure rate after 7 days of randomization
Cure: Cerebrospinal fluid (CSF) white blood cell count, CSF protein concentration, CSF/serum glucose ratio, and CSF bacterial culture are all normal in three consecutive tests. Reference Values for CSF Indicators: white blood cell count \< 100 × 10⁶/L, protein concentration \< 50 mg/dL, CSF/serum glucose ratio \> 0.5.
8,10 and 14 days after randomization
Improvement rate after 7 days of randomization
Improvement: At least one of the following three CSF white blood cell counts, CSF protein concentration, CSF/serum glucose ratio, and CSF bacterial culture is normal. Reference Values for CSF Indicators: white blood cell count \< 100 × 10⁶/L, protein concentration \< 50 mg/dL, CSF/serum glucose ratio \> 0.5.
8,10 and 14 days after randomization
Cerebrospinal fluid white blood cell count at 48-72 hours and Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid white blood cell count
48-72 hours after randomization, Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid protein concentration at 48-72 hours and Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid protein concentration
48-72 hours after randomization, Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid-to-serum glucose concentration ratio at 48-72 hours and Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid-to-serum glucose concentration ratio
48-72 hours after randomization, Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid bacteriological culture results at 48-72 hours and Days 5, 8, 10, and 14 after randomization
Cerebrospinal fluid bacteriological culture results
48-72 hours after randomization, Days 5, 8, 10, and 14 after randomization
Glasgow Coma Scale (GCS) scores at 48-72 hours and Days 5, 8, 10, and 14 after randomization
Glasgow Coma Scale (GCS) is a neurological scale that assesses level of consciousness using 3 components: eye opening, verbal response, and motor response. The total score ranges from 3 to 15, with higher scores indicating a better neurological outcome / level of consciousness and lower scores indicating a worse outcome / deeper impairment of consciousness.
48-72 hours after randomization, Days 5, 8, 10, and 14 after randomization
Proportion of participants who require conversion to intrathecal or intraventricular antibiotic therapy during the 48-72 hour period after randomization
This proportion is defined as the number of participants who are evaluated during the 48-72-hour period after randomization and are judged to have an unsatisfactory treatment response requiring conversion to intrathecal or intraventricular antibiotic therapy, divided by the total number of participants in the corresponding treatment group. An unsatisfactory treatment response is defined as the absence of an improving trend, compared with baseline, in cerebrospinal fluid white blood cell count, protein concentration, and cerebrospinal fluid-to-serum glucose concentration ratio.
During the 48-72 hour period after randomization
All-cause mortality from baseline to 14-day
All-cause mortality
Baseline to Day 14
Mortality due to meningitis from baseline to 14-day
Mortality due to meningitis. The diagnostic criteria are the absence of a downward trend in the cerebrospinal fluid leukocyte count, protein concentration, and the ratio of cerebrospinal fluid glucose concentration to serum glucose concentration prior to death.
Baseline to Day 14
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל

  • 1. Age 18-75 years, gender not limited;

  • 2. Meeting the diagnostic criteria for moderate to severe bacterial meningitis:

    1. Meeting the diagnostic criteria for bacterial meningitis, i.e., meeting at least item i:

      i. Abnormal body temperature (>38℃ or <36℃), turbid or purulent Cerebrospinal fluid (CSF) , CSF leukocytosis (>500×10⁶/L), CSF glucose/serum glucose concentration <0.4, CSF protein concentration >50mg/dL, meeting the clinical diagnosis; ii. In addition to item i, positive microbial tests or cultures of specimen smears, drainage tube heads, implants, and CSF (excluding contamination and colonization), meeting the etiological diagnosis;

    2. GCS score ≤12 points or a decrease of 2 points from the previous score;

    3. At least one of the following conditions is present: altered consciousness, seizures, brain parenchymal involvement, severe manifestations such as mechanical ventilation or circulatory support.

  • 3. After 48-72 hours of antibiotic treatment, if the investigator determines that the patient's condition shows no significant improvement or continues to worsen, or if at least one of the following conditions is present:

    1. Symptoms and signs related to intracranial infection show no trend of relief or worsen;
    2. CSF white blood cell count shows no trend of decrease, or increases after decreasing;
    3. CSF protein concentration shows no trend of decrease, or increases after decreasing;
    4. CSF/serum glucose concentration shows no trend of increase, or decreases after increasing;
    5. CSF bacterial culture remains positive or becomes positive again after initially being negative.

  • 4. Based on the patient's condition, treatment with polymyxin B, tigecycline, or vancomycin may be necessary.

  • 5. Obtain informed consent.

  • 1. History of allergy to polymyxin B, tigecycline, or vancomycin;
  • 2. Received intrathecal or intraventricular antibiotic treatment before randomization;
  • 3. Patients with severe pulmonary infection/acute respiratory distress syndrome (PaO₂/FiO₂ < 150 mmHg, FiO₂ ≥ 0.6, PEEP ≥ 5 cmH₂O) or whose primary cause of mechanical ventilation is not determined to be intracranial infection;
  • 4. Patients with a primary extracranial infection focus (e.g., lungs, abdomen, urinary tract, etc.) who, after adequate fluid resuscitation, require vasoactive drugs to maintain MAP ≥ 65 mmHg (e.g., norepinephrine ≥ 0.25 μg/kg/min) and lactate > 2 mmol/L, or whose primary cause of critical illness is not determined to be intracranial infection;
  • 5. Patients with contraindications to transcranial administration, such as severe skull fracture, poor visualization of the skull diploic, or planned decompressive craniectomy, which may affect transcranial administration.
  • 6. Clinical signs of brain herniation, such as unilateral or bilateral pupillary dilation and fixation; or loss of other brainstem reflexes determined by the investigator to be caused by meningitis or brain herniation; or other uncontrollable signs of unstable vital signs;
  • 7. Bleeding tendency deemed unfavorable for the procedure by the investigator: abnormal coagulation function (e.g., platelet count <50×10⁹/L; prothrombin time \[PT\]>3s), patients with a previous diagnosis of hemophilia or other coagulation disorders;
  • 8. Patients with severe hepatic or renal insufficiency (where severe hepatic insufficiency is defined as alanine aminotransferase (ALT) value ≥3 times the upper limit of normal (ULN) or aspartate aminotransferase (AST) value ≥3 times the ULN; severe renal insufficiency is defined as serum creatinine (CRE) ≥1.5 times the ULN or glomerular filtration rate (eGFR) <40 mL/min/1.73m²;
  • 9. Within the past 3 months, the patient has experienced an acute ST-segment elevation myocardial infarction and/or decompensated heart failure (meeting New York Heart Association \[NYHA\] functional class III or IV).
  • 10. Patients with severe or extremely severe anemia (hemoglobin < 60 g/L) at the time of randomization;
  • 11. Patients with active hepatitis B infection (positive hepatitis B surface antigen and/or positive serum HBV DNA or serum HBV DNA > 2 × 10⁸ IU/ml);
  • 12. Patients with positive hepatitis C virus antibody or a history of positive testing;
  • 13. Patients with positive HIV test or a history of positive testing;
  • 14. Pregnant, lactating, or potentially pregnant patients, or patients planning to become pregnant;
  • 15. Patients currently participating in other interventional trials or who have used other investigational drugs within one month or five drug half-lives;
  • 16. Patients deemed unsuitable for participation in this study by the investigator.
yilong Wang logoyilong Wang
הגורם האחראי למחקר
yilong Wang, חוקר נותן החסות, Vice President of Beijing Tiantan Hospital
איש קשר מרכזי למחקר
איש קשר: Yilong Wang, PhD+MD, 13569869755, [email protected]
6 מיקומי המחקר ב-1 מדינות

Beijing Municipality

Beijing Tiantan Hospital, Beijing, Beijing Municipality, 100071, China
Yilong Wang, MD+PhD, איש קשר, 13569869755, [email protected]

Henan

Kaifeng Central Hospital, Kaifeng, Henan, China
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Henan Provincial People's Hospital, Zhengzhou, Henan, 450000, China
Guang Feng, איש קשר

Shandong

Linyi City People Hospital, Linyi, Shandong, China

Tianjin Municipality

Tianjin Huanhu Hospital, Tianjin, Tianjin Municipality, 300000, China