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Norvancomycin and Vancomycin in Intracranial Infection after Craniotomy: a Randomized Controlled study (NAVy Study)

Norvancomycin and Vancomycin in Intracranial Infection after Craniotomy: a Randomized Controlled stu

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005291
Enrollment
Unknown
Registered
2014-10-05
Start date
1990-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Infection

Interventions

Vancomycin group:Norvancomycin IV 2h, 800mg, Q8h, 21 days
Vancomycin group:Vancomycin IV 2h, 1g, Q8h, 21days

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) After neurosurgery craniotomy; 2) diagnosed as intracranial infection; 3) Aged between 18 to 65 years; 4) Have signed informed consent The diagnostic intracranial infection criteria was two or more of the following changes: (i) temperature higher than 38 or lower than 36, vomiting, headache, positive signs of meningeal irritation (nuchal rigidity, Brudzin ski's sign and Kernig's sign); (ii) positive changes in CSF specimens: white blood cell (WBC) count more than 1000*10^6 cells/L, glucose less than 2.2 mmol/L or less than 40% of serum glucose; and (iii) positive CSF cultures

Exclusion criteria

Exclusion criteria: 1) Aged 18 or above; 2) Allergic history of norvancomycin or vancomycin; 3) Before recruiting, resistance against MRSA or epidermis staphylococcus aureus antibiotics have been used within 72 hours 4) Severe cardiopulmonary, hepatic and renal insufficiency; 5) Maternal in the perinatal period 6) Refused to sign informed consent

Design outcomes

Primary

MeasureTime frame
effect of trial antibiotics;CSF recovery time;

Secondary

MeasureTime frame
LOS in ICU and hospital;mortality;blood routine recovery time;dosage and cost of antibiotics;

Countries

China

Contacts

Public ContactQiang Wang
ttyywq@163.com+86 010-6796518

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026