Self-application of aminoglycoside-based creams to treat cutaneous leishmaniasis in travelers.
Journal
PLoS neglected tropical diseases
ISSN: 1935-2735
Titre abrégé: PLoS Negl Trop Dis
Pays: United States
ID NLM: 101291488
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
24
11
2022
accepted:
30
06
2023
revised:
22
08
2023
medline:
24
8
2023
pubmed:
10
8
2023
entrez:
10
8
2023
Statut:
epublish
Résumé
In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation. Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months. Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group. In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials.
Sections du résumé
BACKGROUND
In endemic foci, the use of an aquaphilic cream containing paromomycin with/without gentamicin to treat cutaneous leishmaniasis (CL) is safe, painless and cures 78-82% of patients with New and Old World CL. Self-application in travelers requires evaluation.
METHODS
Travelers with 1-10 lesions of confirmed CL were prospectively treated with the paromomycin-gentamicin formulation (WR279396, 2012-2017, Group 1) and carefully follow up, or treated with a locally produced paromomycin-only cream (2018-2022, Group 2). The cream was applied once under supervision, then self-applied daily for 20-30 days. A cured lesion was defined as 100% re-epithelialization at day 42 without relapse at three months.
RESULTS
Medical features were similar in Group 1 (17 patients), and Group 2 (23 patients). Patients were infected with either Leishmania major, L. infantum, L. killicki, L. guyanensis, L. braziliensis, or L. naiffi. Intention-to-treat and per-protocol cure rates were 82% (95% confidence interval (CI) [64.23;100.00]) and 87% (95% CI [71,29;100.00]) in Group 1, and 69% (95% CI [50.76; 88.37]) and 76% (95% CI [57.97; 94.41]) in Group 2. In the pooled Group 1&2, 75% (95% CI [61.58;88.42]) (30/40) and 81% (95% CI [68,46;93.6]) (30/37) of patients were cured in intention-to-treat and per-protocol, respectively. There were no significant differences observed in the success rates between Old World and New World CL (83.3% vs. 60%, p = 0.14). Prospective observations in Group 1 showed that adverse events were mainly pruritus (24%) and pain (18%) on lesions (all mild or moderate). No mucosal involvement was observed in either group.
DISCUSSION
In this representative population of travelers who acquired CL either in the Old or New World, the 81% per-protocol cure rate of a self-applied aminoglycoside cream was similar to that observed in clinical trials.
Identifiants
pubmed: 37561802
doi: 10.1371/journal.pntd.0011492
pii: PNTD-D-22-01470
pmc: PMC10443860
doi:
Substances chimiques
Paromomycin
61JJC8N5ZK
Antiprotozoal Agents
0
Aminoglycosides
0
Anti-Bacterial Agents
0
Gentamicins
0
Types de publication
Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e0011492Informations de copyright
Copyright: © 2023 Mouri et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Déclaration de conflit d'intérêts
I have read the journal’s policy and the authors of this manuscript have the following competing interests : PB is member of the scientific advisory committee of Drugs for Neglected Diseases initiative.
Références
Acta Trop. 2011 May;118(2):87-96
pubmed: 21420925
Trans R Soc Trop Med Hyg. 1994 Mar-Apr;88(2):226-8
pubmed: 8036683
Int Health. 2012 Sep;4(3):153-63
pubmed: 24029394
N Engl J Med. 2013 Feb 7;368(6):524-32
pubmed: 23388004
PLoS Negl Trop Dis. 2019 May 2;13(5):e0007253
pubmed: 31048871
Euro Surveill. 2013 Jul 18;18(29):20534
pubmed: 23929121
PLoS Negl Trop Dis. 2017 Nov 20;11(11):e0006094
pubmed: 29155816
Am J Trop Med Hyg. 2014 Jun;90(6):1191
pubmed: 24898981
J Clin Microbiol. 2004 Nov;42(11):5249-55
pubmed: 15528722
J Travel Med. 2014 Mar-Apr;21(2):116-29
pubmed: 24745041
Am J Trop Med Hyg. 1995 Aug;53(2):162-6
pubmed: 7677218
PLoS Negl Trop Dis. 2021 Oct 13;15(10):e0009863
pubmed: 34644288
PLoS Negl Trop Dis. 2022 Jul 8;16(7):e0010569
pubmed: 35802749
Rev Inst Med Trop Sao Paulo. 1999 Jan-Feb;41(1):33-7
pubmed: 10436668
PLoS Negl Trop Dis. 2009;3(5):e432
pubmed: 19415122
Clin Infect Dis. 2013 Aug;57(3):370-80
pubmed: 23633111
Med Mal Infect. 2005 Jan;35(1):42-5
pubmed: 15695033
PLoS Negl Trop Dis. 2016 Jan 06;10(1):e0004304
pubmed: 26735920
PLoS Negl Trop Dis. 2013 Jun 13;7(6):e2255
pubmed: 23785530
Trans R Soc Trop Med Hyg. 1994 Jan-Feb;88(1):92-4
pubmed: 8154018
Clin Infect Dis. 2016 Dec 15;63(12):e202-e264
pubmed: 27941151
Clin Infect Dis. 2019 Feb 15;68(5):844-849
pubmed: 30260376
Emerg Infect Dis. 2019 Apr;25(4):642-648
pubmed: 30882319
Braz J Med Biol Res. 1999 Mar;32(3):297-301
pubmed: 10347787
J Am Acad Dermatol. 1992 Aug;27(2 Pt 1):227-31
pubmed: 1430361
Am J Trop Med Hyg. 2017 Jan 11;96(1):24-45
pubmed: 27927991
Presse Med. 2011 Feb;40(2):173-84
pubmed: 21106333
Am J Trop Med Hyg. 2013 Sep;89(3):557-563
pubmed: 23857024
Lancet. 2018 Sep 15;392(10151):951-970
pubmed: 30126638
Acta Trop. 2004 Jul;91(2):153-60
pubmed: 15234664
PLoS Negl Trop Dis. 2014 May 22;8(5):e2749
pubmed: 24853096
PLoS Negl Trop Dis. 2014 Jun 05;8(6):e2841
pubmed: 24902030