SepsisNCT07245966
Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis
An observational study of Sepsis, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 20 people in total
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant and lactating
- Septic shock patients
- Having the level of serum albumin lower than 2.5 g/dl
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110
About this study
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.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of target attainment of the pharmacodynamic index fT>MIC ≥ 100% for ceftriaxone
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.
Measured: First 24 hours of ceftriaxone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jun 2024
- Primary completion31 Jan 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarunyou Chusri, Prince of Songkla University
- Investigators
- Sarunyou Chusri, M.D., Ph.D., Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245966
- Sponsor's protocol ID
- REC.66-477-14-1
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will remain anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of High Dose Ceftriaxone in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT07245966
- Acronym / sponsor ID
- REC.66-477-14-1
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20 people in total
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No. The data will remain anonymized.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarunyou Chusri, M.D., Ph.D. principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of target attainment of the pharmacodynamic index fT>MIC ≥ 100% for ceftriaxone (time frame: First 24 hours of ceftriaxone treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.