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The pharmacokinetics and effectiveness study of Tigecycline in patients with multidrug-resistant intracranial infections after craniotomy

The pharmacokinetics and effectiveness study of Tigecycline in patients with multidrug-resistant intracranial infections after craniotomy

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-15005793
Enrollment
Unknown
Registered
2014-10-20
Start date
2015-01-01
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 infections after craniotomy

Interventions

Tigecycline group:Tigecycline IV 100mgQ12h for 72 hours, and then evaluate the efficacy of treatment, if the treatment is not effctvie, change to combination of intracerebroventricular and intravenous

Sponsors

Department of Critical Care Medicine, Beijing Tiantan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. After neurosurgery craniotomy; 2. diagnosed as intracranial infection; 3. Aged between 18 to 65 years; 4. Clinical doctors believe it is necessary to use the Tigecycline to treatment; 5. Have signed informed consent The diagnostic intracranial infection criteria was three of the following changes: (1) 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); (2) 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 (3) positive CSF cultures.

Exclusion criteria

Exclusion criteria: 1. Aged less than 18 or above 65; 2. Allergic history of any kind of tetracycline; 3. Severe cardiopulmonary, hepatic and renal insufficiency; 5. Maternal in the perinatal period; 6. Refused to sign informed consent.

Design outcomes

Primary

MeasureTime frame
drug concentrations of serum;drug concentrations of cerebrospinal fluid;CSF penetration of tigecycline;clinical effet of tigecycline;

Secondary

MeasureTime frame
security of tigecycline;Health Economics of tigecycline;

Countries

China

Contacts

Public ContactWang Qiang
ttyywq@163.com+86 010-67096518

Outcome results

None listed

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