ABSTRACT
Purpose: In everyday practice clinicians are overwhelmed by claims from the pharmaceutical industry and, due to marketing efforts, they often view generic multisource products with scepticism despite proof and registration by regulatory authorities of bioequivalence. The primary aim of this study was exploratory and aimed to compare the acceptability of generic cefpodoxime (Cepodem®) versus the innovator brand product (Orelox®) in terms of effectiveness, safety and tolerability in a general private setting in South Africa in the treatment of upper and lower respiratory tract infections.Methods and patients: Ninety patients were recruited and randomised to receive either product for 10 days after clinical diagnoses of either tonsillo-pharyngitis or rhino-sinusitis or pneumonia.Results: It was demonstrated that both products resulted in similar clinical and bacteriological cure rates with also no difference in tolerability profiles. Conclusion: These findings support the bioequivalence data as submitted for regulatory approval, of the generic Cepodem® translating into clinical effectiveness and argues against the need for a clinical non-inferiority study to demonstrate sameness
Subject(s)
Cephalosporins , Therapeutic EquivalencyABSTRACT
Background: Infection by Extended Spectrum Beta Lactamases (ESBLs) producing bacteria is a threat to man as a consequence of treatment challenges. This study evaluated the prevalence and antimicrobial susceptibility pattern of ESBL producing Klebsiellae (EPK) in clinical specimens at the University of Ilorin Teaching hospital, Ilorin (UITH), Nigeria. Methods: ESBL production was assayed using Double Discs Synergy Test (DDST). Antimicrobial susceptibility was performed by Modified Kirby-Baeur method with the organism tested against ceftazidime (30µg), cefotaxime (30µg), amoxicillin clavulinic acid (20/10µg), cefepime (30µg), ciprofloxacin (5µg), gentamicin (10µg), trimethoprim-sulphamethoxazole (23.75/1.25µg), imipenem (10µg) and doripenem (10µg) (Oxoid, UK). Results: Fifty (26.7%) of the 187 Klebsiellae studied were EPK comprising of 37(26.8%) Klebsiella pneumoniae and 13(26.5%) Klebsiella oxytoca. EPK were mostly from wound specimens (24.0%) although Klebsiellae were mostly occurring in sputum (26.2%). The EPK were resistant to ceftazidime (100%), cefotaxime (94.0%), trimethoprim-sulphamethoxazole (92.0%), gentamicin (70.0%) and ciprofloxacin (70.0%) but 100% susceptible to both doripenem and imipenem. Conclusion: The prevalence of EPK in this study is high and they are multi-drug resistant. Carbapenems are the best antibiotic treatment option for infections arising from these organisms although a coordinated rational usage is desired along with functional antibiotic prescription policy to avoid treatment failures. Continuous surveillance for ESBL producing Klebsiellae and resistance monitoring are necessary routine to strengthen infection control policies
Subject(s)
Anti-Bacterial Agents , Cephalosporins , Drug Prescriptions , Klebsiella Infections , NigeriaABSTRACT
La frequence de la resistance d'Escherichia coli a l'Ampicilline et la gravite de ces infections en milieu hospitalier soulignent la necessite pour le traitement de premiere intention: de limiter la prescription de l'Ampicilline dans ces affections; d'utiliser volontiers une Cephalosporine de 2e ou 3e generation ou un Aminoside (si l'etat renal le permet); ou un Quinolone de premiere generation (s'il n'existe pas de contre indications) dans les infections legeres ou extra-hospitalieres; une Cephalosporine de 3e generation associee a un Aminoside; ou un Quinolone de 3e generation en cas d'infections hospitalieres graves