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Pharmacokinetics/ Pharmacodynamics study and dosing regimen optimization of evaluating biapenem in high-risk patients with febrile neutropenia

Pharmacokinetics/ Pharmacodynamics study and dosing regimen optimization of evaluating biapenem in high-risk patients with febrile neutropenia

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024945
Enrollment
Unknown
Registered
2019-08-04
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

high-risk patients with febrile neutropenia

Interventions

Group1:Biapenem 0.3g q6h
Group2:Biapenem 0.3g q8h
Group3:Biapenem 0.6g q6h
Group4:Biapenem 0.6g q8h

Sponsors

The Affilated Hospital of Putian University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Greater than 18 years old, male or female; 2. High-risk patients with febrile neutropenia(Diagnostic criteria refer to the 2010 edition of the treatment guidelines for IDSA); 3. Medication standard is in line with The National Health Commission of the People's Republic of China 's Consensus of Clinical Experts on Using Carbapenem Antibiotics; 4. At least one steady-state plasma concentration can be obtained; 5. Patient and family informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women and lactating women; 2. Those who have a history of allergies to carbapenems, penicillins or other ß-lactam antibiotics; 3. Patients with a history of epilepsy or central nervous system disorders, patients with treating sodium valproate; 4. Patients infected by other pathogenic microorganisms such as viruses, fungi, tuberculosis, mycoplasma, chlamydia, rickettsia or Legionella; 5. Patients with severe liver and kidney dysfunction; 6. Patients who are unable to complete the trial under the study protocol or who are unlikely to complete the expected course of treatment and follow-up and patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Blood Concentration of biapenem;temperature;leukocyte;Neutrophil;C-Reactive Protein;Procalcitonin;Clinical symptoms;

Secondary

MeasureTime frame
Age;Gender;Weight;

Countries

China

Contacts

Public ContactZhang Chaofeng

The Affilated Hospital of Putian University

271127383@qq.com+86 15105913649

Outcome results

None listed

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