Schwameis, Michael, Kundig, Thomas, Huber, Gustave, von Bidder, Luzi, Meinel, Lorenz ORCID: 0000-0002-7549-7627, Weisser, Roland, Aberer, Elisabeth, Haerter, Georg, Weinke, Thomas, Jelinek, Tomas, Faekenheuer, Gerd, Wollina, Uwe ORCID: 0000-0001-5933-2913, Burchard, Gerd-Dieter, Aschoff, Roland, Nischik, Ruth, Sattler, Gerhard, Popp, Georg, Lotte, Wolfgang, Wiechert, Dirk, Eder, Gerald, Maus, Olga, Staubach-Renz, Petra, Graefe, Andrea, Geigenberger, Veronika, Naudts, Ingomar, Sebastian, Michael, Reider, Norbert, Weber, Ridwan, Heckmann, Marc, Reisinger, Emil C., Klein, Georg, Wantzen, Johannes and Jilma, Bernd (2017). Topical azithromycin for the prevention of Lyme borreliosis: a randomised, placebo-controlled, phase 3 efficacy trial. Lancet Infect. Dis., 17 (3). S. 322 - 330. OXFORD: ELSEVIER SCI LTD. ISSN 1474-4457

Full text not available from this repository.

Abstract

Background 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. We assessed its efficacy in human beings. Methods In this randomised, double-blind, placebo-controlled, multicentre trial done in 28 study sites in Germany and Austria, adults were equally assigned to receive topical 10% azithromycin or placebo twice daily for 3 consecutive days, within 72 h of a tick bite being confirmed. Randomisation numbers, which were stratified by study site, were accessed in study centres via an interactive voice-response system, by pharmacists not involved in the study. The primary outcome was the number of treatment failures, defined as erythema migrans, seroconversion, or both, in participants who were seronegative at baseline, had no further tick bites during the study, and had serology results available at 8 weeks (intention-to-treat [ITT] population). This study is registered with EudraCT, number 2011-000117-39. Findings Between July 7, 2011, and Dec 3, 2012, 1371 participants were randomly assigned to treatment, of whom 995 were included in the ITT population. The trial was stopped early because an improvement in the primary endpoint in the group receiving azithromycin was not reached. At 8 weeks, 11 (2%) of 505 in the azithromycin group and 11 (2%) of 490 in the placebo group had treatment failure (odds ratio 0.97, 95% CI 0 42-2 26, p=0.47). Topical azithromycin was well tolerated. Similar numbers of patients had adverse events in the two groups (175 [26%] of 505 vs 177 [26%] of 490, p=0.87), and most adverse events were mild. Interpretation Topical azithromycin was well tolerated and had a good safety profile. Inclusion of asymptomatic seroconversion into the primary efficacy analysis led to no prevention effect with topical azithromycin. Adequately powered studies assessing only erythema migrans should be considered. A subgroup analysis in this study suggested that topical azithromycin reduces erythema migrans after bites of infected ticks.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Schwameis, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kundig, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huber, GustaveUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Bidder, LuziUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meinel, LorenzUNSPECIFIEDorcid.org/0000-0002-7549-7627UNSPECIFIED
Weisser, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aberer, ElisabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haerter, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weinke, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jelinek, TomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faekenheuer, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wollina, UweUNSPECIFIEDorcid.org/0000-0001-5933-2913UNSPECIFIED
Burchard, Gerd-DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aschoff, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nischik, RuthUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sattler, GerhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Popp, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lotte, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiechert, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eder, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maus, OlgaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staubach-Renz, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graefe, AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Geigenberger, VeronikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Naudts, IngomarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sebastian, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reider, NorbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weber, RidwanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heckmann, MarcUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reisinger, Emil C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klein, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wantzen, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jilma, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-238640
DOI: 10.1016/S1473-3099(16)30529-1
Journal or Publication Title: Lancet Infect. Dis.
Volume: 17
Number: 3
Page Range: S. 322 - 330
Date: 2017
Publisher: ELSEVIER SCI LTD
Place of Publication: OXFORD
ISSN: 1474-4457
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
BURGDORFERI SENSU-LATO; ERYTHEMA MIGRANS; MURINE MODEL; TICK BITE; DISEASE; METAANALYSIS; PROPHYLAXIS; PREVALENCE; AFZELII; EUROPEMultiple languages
Infectious DiseasesMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/23864

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item