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Model-Guided Dose Optimization of Cefoperazone-Sulbactam and Levofloxacin for Pneumonia and Urinary Tract Infections in Patients with Hepatic Dysfunction

Model-Guided Dose Optimization of Cefoperazone-Sulbactam and Levofloxacin for Pneumonia and Urinary Tract Infections in Patients with Hepatic Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115805
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Hepatic dysfunction complicated with pneumonia and urinary tract infection

Interventions

Model-guided Group:Following randomization, a 7-day observation period was established. For each patient, blood samples were required to be collected within 24 hours after the initial administration t
Standard-Dose Group: a. CFP-SUL: Administered at a dose of 2 g/1 g via intravenous infusion every 12 hours. b.LVFX: Given as 500 mg through intravenous infusion once a day. The duration of treatment s

Sponsors

Chun' an County First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged 18 years or older. (2) Diagnosed with community- or hospital-acquired pneumonia complicated by urinary tract infection according to the *Guidelines for the Diagnosis and Management of Infectious Pneumonia in Adults* and the *Chinese Expert Consensus on the Diagnosis and Treatment of Urinary Tract Infections*. (3) Hepatic impairment classified as Child–Pugh B or C. (4) Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: (1) History of hypersensitivity or resistance to cefoperazone–sulbactam or levofloxacin. (2) Pregnant or lactating women. (3) Severe renal impairment (GFR < 30 mL/min). (4) Concomitant use of drugs that may affect drug metabolism (e.g., potent CYP inhibitors/inducers). (5) Participation in other clinical trials. (6) Presence of other severe comorbidities. (7) History of drug abuse or dependence. (8) Complications such as respiratory failure or sepsis.

Design outcomes

Primary

MeasureTime frame
Number of Patients Successfully Receiving Intended Treatment;Number of Treatment Failures;Time from Treatment to Clinical Cure Hospitalization;Number of Patients with Clinical Cure within 7 Days;Pneumonia Improvement Time;Urinary Tract Infection Improvement Time;

Secondary

MeasureTime frame
Reasons for Treatment Failure;Attainment Rate of freee time(fT)>MIC Target;Incidence of Adverse Events;

Countries

China

Contacts

Public ContactWang Zhirou

Chun'an County First People's Hospital

17826867421@163.com+86 571 6483 2896

Outcome results

None listed

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