OBJECTIVES: On this basis, a study was conducted in a district hospital to study the therapy outcomes of antibiotic regimens used in pediatric community-acquired pneumonia (CAP) management and to conduct a cost-effectiveness analysis (CE) between IV ampicillin versus combination therapy of IV ampicillin and IV gentamicin.
METHOD: A prospective, randomized, controlled, single blind study was conducted in a pediatric ward in a 80-bed district hospital. Pediatric patients diagnosed with CAP aged 2 months to 5 years old were randomly and equally divided into two treatment arms: ampicillin versus ampicillin plus gentamicin. The dose of IV ampicillin used in this study was 100 mg/kg/day divided every 6 h and 5 mg/kg of IV gentamicin as a single daily dose. Both clinical and economic evaluations were carried out to compare both treatment arms.
RESULTS: With the inclusion and exclusion criteria, only 40 patients diagnosed with CAP were included in the study. The results showed that the two treatment arms were significantly different (P < 0.05) in terms of duration of patients on ampicillin, number of days of hospitalization and time to switch to oral therapy. A significant difference was noted between the two treatment modalities in terms of effectiveness and cost (P < 0.05).
CONCLUSION: Overall, the endpoint of this study showed that the total cost per patient of ampicillin-treated group is cheaper than the total cost with the combination therapy (ampicillin plus gentamicin) and reduced unnecessary exposure to adverse effects or toxicities. Besides that, addition of gentamicin in the treatment modalities will only increase the cost of treatment without introducing any changes in the treatment outcome.
METHODS: Gentamicin, amikacin and vancomycin are thought to be predominantly excreted by the kidneys. A mixed-effects joint model of the pharmacokinetics of these drugs was developed, with a wide dispersion of weight, age and serum creatinine. A dataset created from 18 sources resulted in 27,338 drug concentrations from 9,901 patients. Body size and composition, maturation and renal function were used to describe differences in drug clearance and volume of distribution.
RESULTS: This study demonstrates that GFR is a predictor of two distinct components of renal elimination clearance: (1) GFR clearance associated with normal GFR and (2) non-GFR clearance not associated with normal GFR. All three drugs had GFR clearance estimated as a drug-specific percentage of normal GFR (gentamicin 39%, amikacin 90% and vancomycin 57%). The total clearance (sum of GFR and non-GFR clearance), standardized to 70 kg total body mass, 176 cm, male, renal function 1, was 5.58 L/h (95% confidence interval [CI] 5.50-5.69) (gentamicin), 7.77 L/h (95% CI 7.26-8.19) (amikacin) and 4.70 L/h (95% CI 4.61-4.80) (vancomycin).
CONCLUSIONS: GFR provides a physiological basis for renal drug elimination. It has been used to distinguish two elimination components. This physiological approach has been applied to describe clearance and volume of distribution from premature neonates to elderly adults with a wide dispersion of size, body composition and renal function. Dose individualization has been implemented using target concentration intervention.