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Development and Application of a Target-Controlled Infusion System for Carbapenem Antimicrobial Agents

Development and Application of a Target-Controlled Infusion System for Carbapenem Antimicrobial Agents

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125313
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-01-06
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Sepsis

Interventions

Conventional two-step infusion group:Meropenem 2g, first 0.5g infused intravenously at a fixed rate over 30min, followed by 1.5g infused at a fixed rate over 2.5h
TCI target-controlled infusion group:Self-developed TCI pump infusion (blood drug concentration controlled based on PK/PD model)
Conventional continuous infusion via micro-pump group:Meropenem 2g infused via micro-pump at a fixed rate over 3h

Sponsors

Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age > 18 years old 2.Clearly identified patients with severe infections 3. Highly suspected bacterial infections 4.Have meropenem indications

Exclusion criteria

Exclusion criteria: 1. Make a clear diagnosis of non-bacterial infection. 2. Pregnant and lactating women. 3. Patients who are allergic to meropenem or similar drugs or have severe adverse reactions.

Design outcomes

Primary

MeasureTime frame
Median duration of clinical cure and improvement with meropenem (days from initiation to discontinuation of target antibiotic, until ICU discharge, death, or day 28 after randomization, whichever occurs first);

Secondary

MeasureTime frame
14-day mortality rate;28-day mortality rate;Modified Acute Physiology and Chronic Health Evaluation II (APACHE II) score after treatment;Sequential Organ Failure Assessment (SOFA) score;Duration of mechanical ventilation;Duration of vasopressor use;Length of ICU stay;Hospitalization cost;Improved monitoring method for carbapenem blood drug concentration;Establishment of f%T > MIC calculation model for carbapenems;Optimization of individualized carbapenem dosing regimens in critically ill patients;

Countries

China

Contacts

Public ContactYao Linong

Tangdu Hospital of the Fourth Military Medical University of the People's Liberation Army of China

hero20221010@126.com+86 135 7183 7529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026