Tolerability and efficacy of N-chlorotaurine in infections of different body sites: results of phase II clinical trials
Abstract number: 1134_03_349
Nagl M., Neher A., Teuchner B., Höpfl R., Gottardi W.
N-chlorotaurine (NCT) is a long-lived oxidant produced by human leukocytes during inflammation. Its crystalline sodium salt can be synthetized chemically, and it has broad spectrum antimicrobial activity against bacteria, fungi, and viruses. Because of mild activity and therefore low toxicity NCT is thought to be useful as an antiseptic applicable to different body sites. We performed three clinical phase II studies to evaluate efficacy and tolerability in otitis externa, epidemic keratoconjunctivitis, and chronic leg ulcers with a purulent coating.
Aqueous 1% NCT (55 mM) solution was applied topically for 57 days in all three indications. All studies were designed with a randomized test (NCT) and control group (standard medication). The otitis externa and epidemic keratoconjunctivitis study were double-blind. Evaluation was done clinically using a scoring system for subjective and objective symptoms and microbiologically.
NCT was well tolerated in all indications, little burning in the eye for a few minutes in few patients like sweat and significantly less burning (P < 0.05) than by chloramine T in purulent crural ulcers were the only side effects. Granulation and re-epithelialization in ulcers appeared earlier in the NCT group (P < 0.05). NCT was equally effective in removal of the purulent coating than the stronger antiseptic chloramine T. The clinical symptoms of external otitis decreased 2 days earlier in the test group than in the control group treated with a combination of polymyxin B, neomycin, and hydrocortisone (P < 0.01). Regarding epidemic conjunctivitis, severe courses caused mainly by adenovirus type 8 showed a reduction of symptoms after 35 days, which was earlier than in the control group mock treated with gentamicin (P < 0.05).
The mild antiseptic NCT is excellently tolerated and effective in infections of different body sites. As an endogenous amino acid derivative toxic and allergic side effects have never been observed, and it can be applied without additives. Because of these advantages NCT can be estimated as a very promising antimicrobial agent in human medicine.
|Session name:||XXIst ISTH Congress|
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