Single-dose pharmacokinetics of ceftriaxone in infants and young children

Schaad, Urs B.; Stoeckel, Klaus

doi:10.1128/aac.21.2.248

Cited by 73 publications

(48 citation statements)

References 23 publications

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“…Interestingly, it was observed that the developed PK model, after proper refinement, can be extrapolated to pediatric population. As per the model, the estimated CL and V D were similar to that reported in the literature (12,13). further reiterating the generalizablity and utilizability of the developed population PK model.…”

Section: Discussionsupporting

confidence: 69%

“…The inappropriate changes in exposures might result in sub-optimal efficacy and/or compromised safety. The developed model with weight as covariate was used to predict the PK parameters (and hence exposures) in pediatric data sets extracted from literature (12,13). Interestingly, it was observed that the developed PK model, after proper refinement, can be extrapolated to pediatric population.…”

Section: Discussionmentioning

confidence: 99%

“…The PK data of ceftriaxone and sulbactam in pediatric population was taken from literature (12,13). The individual concentrations were predicted and compared using Bayesian approach, as explained in external model validation; and associated PK parameters were compared with the reported values in the literature (12,13).…”

Section: Model Prediction In Pediatric Populationmentioning

confidence: 99%

“…The utilizability of the model was extrapolated to predict the PK parameters (and hence exposures) in pediatric data sets extracted from literature (12,13). The demographics of pediatric subjects used in the ceftriaxone and sulbactam study are given in supplementary Table 3.…”

Section: Utilizability Of Developed Population Pk Model: Pediatric Exmentioning

confidence: 99%

“…Therefore, the utilizability of the model was extended to predict the PK parameters (and hence exposures) in pediatric population. The concentration-time data and estimated parameters for pediatrics were taken from the published study (12,13). The population PK model predicted parameter values in pediatrics were compared with that observed in published study, and thus, the reliability of the model was assessed for understanding exposures of FDC's active components in pediatric population.…”

Section: Introductionmentioning

confidence: 99%

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Population Pharmacokinetics of Fixed Dose Combination of Ceftriaxone and Sulbactam in Healthy and Infected Subjects

et al. 2015

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ABSTRACT. Increased antibacterial resistance (ABR) and limited drug discovery warrant optimized use of available antibiotics. One option is to rationally combine two antibiotics (fixed dose combination (FDC)) that may delay or prevent emergence of ABR in notorious pathogen. Major concern with FDC is the mutual interaction of its components that might influence their pharmacokinetic (PK) profile, requiring reassessing of whole formulation (adding cost and time). The interaction can be identified by comparing PK profile of a drug present in FDC with its independent entity. An open-label, crossover, single-dose comparative PK study of FDC (ceftriaxone and sulbactam) with their individual reference formulations was performed in 24 healthy adult subjects. No mutual PK interactions between ceftriaxone and sulbactam were observed. Pharmacokinetic data was used to develop a population-PK model to understand between-subject variability (BSV). Pharmacokinetics of ceftriaxone/sulbactam was explained by one and two compartment models, respectively. The subject's Bweight^was identified as a covariate explaining BSV. Both internal and external validations (healthy/infected subjects) were done. The modelderived population-PK parameters of FDC's active components in infected subjects were similar to literature reported values of individual components. Efficacies of various FDC dosage regimens over a range of minimum inhibitory concentrations (MICs) were assessed by Monte Carlo simulations using population-PK parameters of infected/healthy subjects. In infected subjects, 3 g FDC/24 h can treat bacteria with MIC ≤8 μg/mL, while for MIC 8-32 μg/mL, 3 g FDC/12 h is recommended. Lastly, the developed population-PK model was successfully used to predict drug exposure in pediatric population.

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Section: Discussionsupporting

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Section: Model Prediction In Pediatric Populationmentioning

confidence: 99%

Section: Utilizability Of Developed Population Pk Model: Pediatric Exmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Population Pharmacokinetics of Fixed Dose Combination of Ceftriaxone and Sulbactam in Healthy and Infected Subjects

et al. 2015

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Ceftriaxone Therapy in Pediatric Patients

Harrison¹

1983

Arch Pediatr Adolesc Med

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Outpatient management of fever in children with sickle cell disease (SCD) in an African setting

et al. 1999

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Because hospitalization and intravenous antibiotics for treatment of a potentially fatal bacterial infection in febrile children with sickle cell disease (SCD) are difficult to apply, outpatient treatment has been considered in developed countries for selected patients. Eligibility criteria and procedures may differ in developing countries because of unique economic and social conditions. After clinical evaluation within 36 hr of the onset of a fever exceeding 38.5 degrees C, children with SCD who are being closely followed as a part of a SCD cohort in Cotonou (West Africa), were treated as outpatients. The antibiotic regimen consisted of intramuscular injection of ceftriaxone 50 mg/kg/day for 2 days followed by amoxicillin 25 mg/kg x 3/day x 4 days and oral hyper-hydration. Patients were observed for 6 hr and thereafter discharged with a medical control at day 2, day 8 + day 15. All 60 children included completed their treatment, and none were lost to follow-up. A definite or a presumed bacterial infection was the cause of the febrile episode in 76.7% of cases. An appreciable decrease in fever was observed from day 2 and only 2 patients were hospitalized at day 3, one for abdominal painful crisis and one other for persistent fever without documented infection. No severe bacterial infections, recurrence of febrile episode, nor death were encountered during the follow-up. The cost of this outpatient approach is US $30 per patient as compared to US $140 per patient if the patient had been hospitalized. Outpatient management of febrile episode in children with SCD is feasible and cost-effective in Sub-Saharan African. It requires, however, improved medical education on SCD and immediate medical attention after the onset of fever.

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Single-dose pharmacokinetics of ceftriaxone in infants and young children

Cited by 73 publications

References 23 publications

Population Pharmacokinetics of Fixed Dose Combination of Ceftriaxone and Sulbactam in Healthy and Infected Subjects

Population Pharmacokinetics of Fixed Dose Combination of Ceftriaxone and Sulbactam in Healthy and Infected Subjects

Ceftriaxone Therapy in Pediatric Patients

Outpatient management of fever in children with sickle cell disease (SCD) in an African setting

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