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An Exploratory Research of Carrimycin Combined with Conventional Therapy in Treatment of Complicated Infection in Neurocritical Care Unit

An Exploratory Research of Carrimycin Combined With Conventional Therapy in Treatment of Complicated Infection in Neurocritical Care Unit

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050363
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Intracranial infection/Pulmonary infection

Interventions

Intracranial infection group:Carrimycin tablets 400mg/day for 8 days
Pulmonary infection group:Carrimycin tablets 400mg/day for 8 days

Sponsors

Shanghai Sixth People's Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients in Neurocritical Care Unit; 2. Patients who meets the diagnostic criteria for intracranial or pulmonary infection according to the consensus of clinical diagnosis and treatment; 3. Patients who were confirmed CRO Infection: Carbapenem-resistant E.coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter Bowman were detected in cerebrospinal fluid or respiratory secretions; 4. Age 18 to 70 years(including boundary values), male and female; 5. The subject or legal representative agrees to receive treatment and voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to study drug or active ingredients; 2. Patients whose condition can not be reversed or who are in a terminal state; 3. Patients with bloodstream infection; 4. Patients with severe liver dysfunction and who have a Child-pugh score of C; 5. Patients with severe renal impairment (Creatinine Clearance Rate < 30 ml/min); 6. Severe gastrointestinal dysfunction that may affect the intake, transport or absorption of the drug being studied; 7. Join in a clinical trial of any drug or medical device within one month, or within 5 half-lives of other experimental drugs before screening; 8. Combined with other antibiotics that can bind to the 50s subunit of the ribosome to inhibit protein synthesis, including chloramphenicol, lincomycin and macrolides; 9. Pregnant and lactating women, subjects (both women and men) had family planning during the next six months; 10. Other conditions that the researchers considered unsuitable for study participation.

Design outcomes

Primary

MeasureTime frame
Temperature;Clearance rate of carbapenem-resistant Organism;Cerebrospinal fluid test (white blood cell count, sugar content, protein);Microbiological examination (sputum, urine, cerebrospinal fluid culture);

Secondary

MeasureTime frame
C-reactive protein and procalcitonin;Infection indicators such as the percentage of white blood cells and neutrophils;Imaging evaluation of the severity of infection;

Countries

China

Contacts

Public ContactChen Hao

Shanghai Sixth People's Hospital

chenhao_316@aliyun.com+86 18930173769

Outcome results

None listed

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