PURPOSE: Clinical experience attributable to oral form of old antibiotics like ampicillin/sulbactam in children with respiratory tract infections is scarcely recorded in most of countries on current days and in real life setting, maybe due to growing interest in new drugs.
METHODS: We developed a survey entitled ECASEN, to study a cohort of 234 pediatric patients (107 male; 3.79 ± 3.54) in the real life ambulatory setting prospectively. The entities to analyze were: Otitis Media, Tonsillitis, Sinusitis, and Pneumonia. Global symptoms (GSyS) and signs (GSiS) severity were scored through a visual analogue scale (VAS) at initial visit and at the end of therapy. GSiS was: 0-absent, 1-Mild, 2-Moderate, 3-Severe, and 4-very severe. It was analized concurrent diseases, additional drugs, and compliance rate with safety and clinical efficacy. Some samples were studied microbiologically for Gram stain and culture.
RESULTS: The most common entity treated was sinusitis (31%), followed by acute otitis media (17%). In average, patients/relatives featured GSyS as 6.68 ± 1.95 at the beginning and 0.81 ± 1.16 at the end, being 0: absent and 10: very bothering. GSiS was 2.17 ± 0.61 at starting and 0.22 ± 0.46 at the end (p<0.001, respectively). The most common concomitant disease was Allergic Rhinitis. 53 samples were studied finding 18 M catarrhalis, 13 S aureus, 11 S pneumoniae, 9 H influenzae; all them sensitive to sultamicillin. Relevant adverse events were found in 28 subjects: and most of them were gastrointestinal like diarrhea and vomiting.
CONCLUSION: This experience in the real life with sultamicillin signals that it can be used when a child require therapy with a beta-lactam plus a beta-lactamase inhibitor for RTIs with some gatrointestinal adverse events as other antibiotics.
CLINICAL IMPLICATIONS: Real life setting recordings are useful tools for supporting evidence related to safety and efficacy of available antibiotics showing if they can be used with the original confidence or not.
DISCLOSURE: Gemzel Hernandez, Employee Pfizer Venezuela.