Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis

As the general treatment method for infectious diseases is to prescribe antibiotics which can be complete at the empirical treatment with the control of the sources of infection, the types of antibiotics that contain the broad spectrum and the proper dose to reduce the severity of infection play an important role. Especially, patients with sepsis should receive antibiotics within 1 hours after the diagnosis since the delay of 1 hour will decrease the rate of survival by 7.6 percent. Ceftriaxone is considered to be Cephalosporin, the antibiotics in the group of β-lactams antibiotic which kills bacteria by preventing the creation of significant cell walls. Ceftriaxone is soluble and can be excreted by the kidney. It is a β-lactams broad spectrum which can kill bacteria broadly including various types of gram-positive and gram-negative. The effectiveness of Ceftriaxone is in accord with the percentage of time that the level of the drug is beyond the minimum inhibitory concentration. According to the research in animals conducted by Craig WA and others, the drug effect to prevent the bacteria growth will occur when the %ft>MIC is more than at least 40%. The rate of prevention will reach the maximal bactericidal effect when the %ft>MIC is equal to 60 to 70%. At the moment, physicians prefer the 60 to 70% of %ft>MIC in the group of Cephalosporins drugs as the main pharmacodynamics to cope with infections.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants aging over 18 years old with the symptoms of systemic inflammatory response syndrome (SIRS) which requires at least two of the following symptoms
Temperature over 38 degree Celsius (Fever) or lower than 36 degree Celsius (hypothermia)
Tachycardia
Tachypnea, or the detection of PaCO2 under 32 mmHg, or hypocapnia due to hyperventilation
Participants are about to received Ceftriaxone by the physician
Weighting equal to or more than 50 kg

Exclusion criteria

Patients with the clinical record of the severe allergy to β-lactam or Ceftriaxone
Patients received Ceftriaxone within 3 days before the participation
Having a culture result of being resistant to Ceftriaxone
Having CLcr lower than 50 ml/min, or receiving hemodialysis, or renal replacement therapy
Meningitis patients
Decompensated liver disease
Pregnant and lactating
Septic shock patients
Having the level of serum albumin lower than 2.5 g/dl

Treatment and study plan

Primary outcomes

Probability of target attainment of the pharmacodynamic index fT>MIC ≥ 100% for ceftriaxone

Time frame: First 24 hours of ceftriaxone treatment

The percentage of simulated patients achieving the pharmacodynamic target of free drug time above MIC (fT>MIC ≥ 100%), estimated using population pharmacokinetic modeling incorporating observed plasma concentration-time data and pathogen-specific MIC values or reference MIC distributions.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 24, 2025
Registry last updated: Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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