Objective Chronic suppurative otitis media (CSOM) is a chronic infectious disease with worldwide prevalence that causes hearing loss and decreased quality of life. As current (antibiotic) treatments often unsuccessful and antibiotic resistance is emerging, alternative agents and/ or strategies are urgently needed. We considered the synthetic antimicrobial and anti-biofilm peptide P60.4Ac to be an interesting candidate because it also displays anti-inflammatory activities including lipopolysaccharide-neutralizing activity. The aim of the present study was to investigate the safety and efficacy of ototopical drops containing P60.4Ac in adults with CSOM without cholesteatoma. Methods We conducted a range-finding study in 16 subjects followed by a randomized, double blinded, placebo-controlled, multicentre phase II a study in 34 subjects. P60.4Ac-containing ototopical drops or placebo drops were applied twice a day for 2 weeks and adverse events (AEs) and medication use were recorded. Laboratory tests, swabs from the middle ear and throat for bacterial cultures, and audiometry were performed at intervals up to 10 weeks after therapy. Response to treatment was assessed by blinded symptom scoring on otoscopy.
A 59 year old woman was admitted to hospital with a three day history of a sore throat and increasing dysphagia. During treatment with oral penicillin for one day, pain and dysphagia progressed and the patient was admitted. On examination, she was afebrile, her soft palate and uvula were swollen, and a membraneous exudate was seen on the soft palate and nasopharynx.
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