Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h
| Autor: | Jean Li Yan, Rienk Pypstra, Jennifer Hammond, Karen Cheng |
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| Rok vydání: | 2018 |
| Předmět: |
Male
0301 basic medicine Microbiology (medical) Staphylococcus aureus medicine.medical_specialty medicine.drug_class 030106 microbiology Cephalosporin Microbial Sensitivity Tests Drug Administration Schedule law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans Ceftaroline fosamil Pharmacology (medical) 030212 general & internal medicine Adverse effect Original Research Pharmacology business.industry Staphylococcal Infections Rash Anti-Bacterial Agents Cephalosporins Discontinuation Regimen Treatment Outcome Infectious Diseases Tolerability Female medicine.symptom business medicine.drug |
| Zdroj: | Journal of Antimicrobial Chemotherapy |
| ISSN: | 1460-2091 0305-7453 |
| Popis: | Background The recommended adult dose of ceftaroline fosamil is 600 mg q12h by 1 h intravenous (iv) infusion for 5–14 days in complicated skin and soft tissue infection (cSSTI) and 5–7 days in community-acquired pneumonia (CAP). A dosage of 600 mg q8h by 2 h iv infusion is approved in some regions for cSSTI patients with Staphylococcus aureus infection where the ceftaroline MIC is 2 or 4 mg/L. This analysis compares the safety profiles of the q8h and q12h regimens. Methods Safety data from six Phase III, randomized, double-blind clinical trials were collated into the q8h cSSTI pool (ceftaroline fosamil n = 506; NCT01499277) and the q12h pool {ceftaroline fosamil n = 1686; comprising five studies [two cSSTI (NCT00424190 and NCT00423657) and three CAP (NCT01371838, NCT00621504 and NCT00509106)]}. Results The pattern and incidence of adverse events were similar between the q8h and q12h ceftaroline fosamil pools. Most were gastrointestinal and of mild or moderate intensity. Overall, rash intensity was similar between the q8h pool and the q12h pool. For the q8h regimen, there was a higher frequency of rash in some Asian study sites, associated with longer duration of therapy (≥7 days); most cases were mild and resolved following treatment discontinuation. No dose-related vital sign or ECG abnormalities were detected with either regimen. Conclusions The q8h regimen in cSSTI was generally well tolerated; the observed safety profile was consistent with the known safety profile of ceftaroline fosamil, reflective of the cephalosporin class and qualitatively consistent with the q12h regimen. |
| Databáze: | OpenAIRE |
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