April 2018 - Michael Schwameis

Dr. Michael Schwameis

MedUni Wien RESEARCHER OF THE MONTH, April 2018

Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial
Lyme borreliosis develops in 1–5% of individuals bitten by ticks, but with a diagnostic gap affecting up to 30% of patients, a broadly applicable pharmacological prevention strategy is needed. Topical azithromycin effectively eradicated Borrelia burgdorferi sensu lato from the skin in preclinical studies. This study assessed its efficacy, safety and tolerability in human beings. The multicentre trial enrolled 1371 adults, who were equally assigned to receive topical azithromycin or placebo twice daily for 3 days, within 72 h of a tick bite being confirmed. The primary outcome was the number of treatment failures at 8 weeks in the intention-to-treat population (n=995). Topical azithromycin reduced erythema migrans after bites of infected ticks in a subgroup analysis, was well tolerated and had a good safety profile.

Selected Literature

1. Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial. Schwameis M, Kündig T, Huber G, von Bidder L, Meinel L, Weisser R, Jilma B et al. Lancet Infect Dis. 2016 Dec 19. pii: S1473-3099(16)30529-1. doi: 10.1016/S1473-3099(16)30529-1. PMID: 28007428
2. ECDC. Tick maps: tick species—distribution maps. http://ecdc.europa.eu/en/healthtopics/vectors/vector-maps/Pages/VBORNET-maps-tick-species.aspx (accessed May 18, 2016).
3. Shih CM, Pollack RJ, Telford SR, 3rd, et al. Delayed dissemination of Lyme disease spirochetes from the site of deposition in the skin of mice. The Journal of infectious diseases 1992; 166(4): 827-31. PMID: 1527418
4. Asphyxia by Drowning Induces Massive Bleeding Due To Hyperfibrinolytic Disseminated Intravascular Coagulation. Schwameis M, Schober A, Schörgenhofer C, Sperr WR, Schöchl H, Janata-Schwatczek K, Kürkciyan EI, Sterz F, Jilma B. Crit Care Med. 2015 Nov;43(11):2394-402. doi: 10.1097/CCM.0000000000001273. PMID: 26327200
5. Anaplasmataceae-Specific PCR for Diagnosis and Therapeutic Guidance for Symptomatic Neoehrlichiosis in Immunocompetent Host. Schwameis M, Auer J, Mitteregger D, Simonitsch-Klupp I, Ramharter M, Burgmann H, Lagler H. Emerg Infect Dis. 2016 Feb;22(2):281-4. doi: 10.3201/eid2202.141762. PMID: 26811875
6. Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial. Ramsauer K*, Schwameis M*, Firbas C, Müllner M, Putnak RJ, Thomas SJ, Desprès P, Tauber E, Jilma B, Tangy F. Lancet Infect Dis. 2015 May;15(5):519-27. doi: 10.1016/S1473-3099(15)70043-5. Epub 2015 Mar 2. PMID: 25739878
7. Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial. Schwameis M*, Roppenser B*, Firbas C, Gruener CS, Model N, Stich N, Roetzer A, Buchtele N, Jilma B, Eibl MM. Lancet Infect Dis. 2016 Jun 10. pii: S1473-3099(16)30115-3. doi: 10.1016/S1473-3099(16)30115-3. PMID: 27296693