ALTABAX SUMMARY
ALTABAX ™(retapamulin ointment), 1%
ALTABAX contains retapamulin, a semisynthetic pleuromutilin antibiotic.
ALTABAX is indicated for use in adults and pediatric patients aged 9 months and older for the topical treatment of impetigo (up to 100 cm2 in total area in adults or 2% total body surface area in pediatric patients aged 9 months or older) due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ALTABAX and other antibacterial drugs, ALTABAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
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NEWS HIGHLIGHTS
Published Studies Related to Altabax (Retapamulin)
Efficacy and safety of retapamulin ointment as treatment of impetigo: randomized double-blind multicentre placebo-controlled trial. [2008.05]
BACKGROUND: Impetigo is a common skin infection, primarily caused by Staphylococcus aureus and mainly occurring in children. It is usually treated topically with antibiotics to achieve a quick cure and prevent spread of the infection. Worldwide, resistance rates of S. aureus against commonly used antibiotics are rising. Retapamulin belongs to a newly developed class of antibiotics for the treatment of uncomplicated skin infections. OBJECTIVES: Our aim was to compare the efficacy and safety of topical application of retapamulin ointment with topical placebo ointment in the treatment of primary impetigo... CONCLUSIONS: This study shows that topical retapamulin is effective and safe in the treatment of primary impetigo, offering a new treatment option.
Topical retapamulin ointment, 1%, versus sodium fusidate ointment, 2%, for impetigo: a randomized, observer-blinded, noninferiority study. [2007]
BACKGROUND: Retapamulin is a novel pleuromutilin antibacterial developed for topical use. OBJECTIVE: To compare the efficacy and safety of retapamulin ointment, 1% (twice daily for 5 days), with sodium fusidate ointment, 2% (3 times daily for 7 days), in impetigo... CONCLUSION: Retapamulin is a highly effective and convenient new treatment option for impetigo, with efficacy against isolates resistant to existing therapies. 2007 S. Karger AG, Basel
Topical retapamulin ointment (1%, wt/wt) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis: results of a randomized controlled trial. [2006.12]
BACKGROUND: New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis (SID). OBJECTIVE: We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1% versus oral cephalexin for the treatment of SID... CONCLUSIONS: 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.
Retapamulin ointment twice daily for 5 days vs oral cephalexin twice daily for 10 days for empiric treatment of secondarily infected traumatic lesions of the skin. [2006.09]
INTRODUCTION: Retapamulin is a novel, topical antibacterial of the pleuromutilin class in development for the treatment of secondarily infected traumatic lesions of the skin... CONCLUSIONS: Retapamulin offers a novel, effective, and convenient topical treatment for secondarily infected traumatic lesions.
Microbiological profile of a new topical antibacterial: retapamulin ointment 1%. [2009.04]
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...
Clinical Trials Related to Altabax (Retapamulin)
Trial of Treatment of Atopic Dermatitis With Concurrent Altabax® and Topical Low-Potency Corticosteroids Versus Low-Potency Corticosteroid Mono-Therapy [Not yet recruiting]
This study is designed to determine whether the addition of topical Altabax (R) to a
treatment regimen of topical corticosteroid therapy speeds clearance of atopic dermatitis
and improves quality of life.
Efficacy Study of Altabax to Clear Methicillin-Resistant Staphylococcus Aureus (MRSA) Nasal Colonization [Not yet recruiting]
The purpose of the study is to determine whether Altabax (retapamulin ointment, 1%) is
effective in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) nasal
colonization. The hypothesis is that the prevalence of MRSA increases as a function of
increasing clinical exposure and that the topical antibiotic Altabax is efficacious in
clearing MRSA nasal colonization. The prevalence of MRSA nasal colonization among Tulane
University medical students and residents and physicians of Tulane Medical Center and
Ochsner Medical Center will be investigated. A total of 300 subjects will be recruited for
the study. After giving informed consent, subjects will be swabbed to obtain specimens for
culture and asked to complete a short survey to assess risk factors. Swabs will be used to
directly inoculate three types of plates: CHROMagar MRSA plates, Spectra MRSA plates, and
TSA with sheep blood plates. After appropriate incubation, Staph latex slide tests will be
done and then results confirmed with cefoxitin disk susceptibility testing. MRSA positive
subjects will be offered a treatment protocol with the topical antibiotic Altabax
(retapamulin ointment, 1%) to be applied as a thin layer to the anterior nares twice daily
for 5 days. After the 5-day treatment is complete, subjects will be retested for the
presence of MRSA at day 7, day 12, day 30, and day 90. For this portion of the study, all
cultures will additionally undergo disk susceptibility testing for retapamulin,
erythromycin, clindamycin (including D-test), trimethoprim sulfa, and mupirocin (5 mcg and
20 mcg disks). In addition, Etests for retapamulin and mupirocin will be done. Genetic
isolates will be characterized by rep-PCR pre-treatment and post-treatment. Data will be
analyzed for MRSA prevalence and risk factor associations with MRSA colonization. Of those
subjects found to be MRSA positive, data from the follow-up cultures will be used to assess
the efficacy of Altabax in clearing MRSA nasal colonization.
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. [Recruiting]
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects
(2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,
or impetigo (bullous and non-bullous).
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL) [Recruiting]
The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin
ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which
includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months
of age and older will be treated with topical retapamulin or placebo ointment twice daily
for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day
12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA [Recruiting]
The purpose of this study is to provide further evidence of the clinical and bacteriological
efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA.
Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days
or oral linezolid for 10 days. The primary endpoint is the clinical response at follow-up
(7-9 days after the end of therapy) in subjects who have a MRSA infection at baseline. The
primary population is the per-protocol MRSA population. It is anticipated that approximately
500 subjects may be enrolled in order to obtain approximately 105 subjects who have a
baseline MRSA infection.
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Page last updated: 2009-10-20
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