retapamulin and Streptococcal-Infections

Retapamulin is a new topical pleuromutilin antibiotic for the treatment of skin and skin-structure infections, including impetigo. In vitro studies indicate that retapamulin has a unique mode of action that minimizes the potential for target-specific cross-resistance with other antibacterials and a limited potential for resistance development. Its spectrum of activity includes the most likely causative pathogens Staphylococcus aureus and Streptococcus pyogenes. In the Global Surveillance Program, retapamulin was highly active in vitro, including against strains of S. aureus resistant to methicillin, mupirocin or fusidic acid. In clinical studies, retapamulin was noninferior to fusidic acid and oral cefalexin, achieving per-pathogen success rates of 86-99%. Topical retapamulin has a good safety profile and is associated with high patient compliance.

Topics: Administration, Cutaneous; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Diterpenes; Drug Resistance, Bacterial; Global Health; Humans; Microbial Sensitivity Tests; Ointments; Population Surveillance; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pyogenes; Treatment Outcome

Topical retapamulin (Altabax, Altargo) is the first pleuromutilin antibacterial approved for the treatment of uncomplicated superficial skin infections caused by Staphylococcus aureus (excluding meticillin-resistant S. aureus [MRSA]) and Streptococcus pyogenes in patients aged > or = 9 months. In the EU, retapamulin is indicated for use in patients with impetigo or with infected small lacerations, abrasions or sutured wounds (without abscesses); in the US, it is indicated for use in patients with impetigo. Retapamulin has a novel site of action on bacterial ribosomes. In clinical trials in patients with impetigo, topical retapamulin 1% ointment twice daily for 5 days (the approved regimen) was superior to placebo; treatment with retapamulin was noninferior to that with topical fusidic acid. In patients with secondarily infected traumatic lesions, treatment with retapamulin was noninferior to that with oral cefalexin, although the efficacy of retapamulin was reduced in patients with MRSA infections or superficial abscesses. Retapamulin was well tolerated in both paediatric and adult patients, and the majority of adverse events were of mild to moderate severity. Thus, the introduction of topical retapamulin 1% ointment extends the treatment options available in the management of impetigo and uncomplicated secondarily infected traumatic lesions.

Topics: Administration, Cutaneous; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Diterpenes; Humans; Impetigo; Skin Diseases, Bacterial; Streptococcal Infections; Treatment Outcome

Topics: Administration, Topical; Animals; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Diterpenes; Drug Resistance, Bacterial; Humans; Protein Synthesis Inhibitors; Skin Diseases, Bacterial; Staphylococcal Skin Infections; Streptococcal Infections; Treatment Outcome

To evaluate whether retapamulin 1% is clinically superior to a placebo in the treatment of patients with secondarily infected traumatic lesions.. The study was a double-blind, placebo-controlled, parallel-group, phase 3 study.. Patients were recruited from 5 countries.. The aforementioned patients were all 2 months or older and diagnosed with secondarily infected traumatic lesions.. Study medication was applied twice daily for 5 days.. Primary end point: clinical response (success/failure) at follow-up. Secondary efficacy end points included clinical and microbiological outcomes at end of therapy (on days 7-9); microbiological and therapeutic responses at follow-up.. A total of 508 patients were recruited for the study; 359 patients were included in the primary efficacy analysis population (246 received retapamulin; 113 received the placebo). Secondarily infected abrasions were the most common secondarily infected traumatic lesions present (56.3%), Staphylococcus aureus being the most frequently isolated pathogen at baseline (60.1%); 15.1% infections were methicillin-resistant. At follow-up, patients receiving retapamulin had higher clinical success rates than those receiving the placebo (74.8% vs 66.4%, respectively) in the primary efficacy analysis population; however, the treatment difference was not statistically significant (8.4%; 95% confidence interval, -1.6 to 18.4). The proportion of patients experiencing adverse events, which were typically mild or moderate in severity, was similar between the retapamulin (5.6%, 19/342) and placebo groups (4.8%, 8/165).. Clinical success rates were higher with retapamulin versus placebo in the treatment of patients with secondarily infected traumatic lesions, but the difference between treatment groups was not significant. Retapamulin was well tolerated.

Topics: Administration, Topical; Adolescent; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Child; Child, Preschool; Diterpenes; Double-Blind Method; Drug Resistance, Bacterial; Female; Humans; Infant; Male; Ointments; Placebo Effect; Staphylococcal Skin Infections; Streptococcal Infections; Treatment Outcome

New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis (SID).. We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID.. Patients with SID were randomly assigned to retapamulin ointment 1% (twice daily [bid]) for 5 days, or oral cephalexin (500 mg bid) for 10 days. The primary efficacy end point was clinical response at follow-up. Secondary outcomes included microbiologic response at follow-up, safety, and compliance.. Retapamulin was as effective as cephalexin (clinical success rates at follow-up: 85.9% and 89.7%, respectively). Microbiologic success rates at follow-up were 87.2% for retapamulin and 91.8% for cephalexin. Retapamulin was well tolerated and the topical formulation was preferred over the oral drug.. An imbalance existed in the number of patients with the clinical outcome "unable to determine" (15 retapamulin, 2 cephalexin), mainly because of their failure to attend the study visit. If those who failed to attend visits (who did not withdraw as a result of drug-related events) are removed from the analysis, the clinical success rates are 89.9% for retapamulin and 89.7% for cephalexin.. Retapamulin ointment 1% (bid) for 5 days was as effective as oral cephalexin (bid) for 10 days in treatment of patients with SID, and was well tolerated.

Topics: Administration, Cutaneous; Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Cephalexin; Child; Child, Preschool; Dermatitis; Dermatitis, Atopic; Diterpenes; Double-Blind Method; Female; Follow-Up Studies; Humans; Infant; Infant, Newborn; Male; Methicillin Resistance; Middle Aged; Ointments; Skin Diseases, Infectious; Staphylococcal Skin Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pyogenes; Treatment Outcome