A randomized controlled trial of local heat therapy versus intravenous sodium stibogluconate for the treatment of cutaneous Leishmania major infection

Cutaneous Leishmania major has affected many travelers including military personnel in Iraq and Afghanistan. Optimal treatment for this localized infection has not been defined, but interestingly the parasite is thermosensitive. Participants with parasitologically confirmed L. major infection were r...

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Bibliographic Details
Published in:PLoS neglected tropical diseases 2010-03, Vol.4 (3), p.e628-e628
Main Authors: Aronson, Naomi E, Wortmann, Glenn W, Byrne, William R, Howard, Robin S, Bernstein, Wendy B, Marovich, Mary A, Polhemus, Mark E, Yoon, In-Kyu, Hummer, Kelly A, Gasser, Jr, Robert A, Oster, Charles N, Benson, Paul M
Format: Article
Language:English
Subjects:
Adolescent
Adult
Animals
Antimony Sodium Gluconate - administration & dosage
Antimony Sodium Gluconate - therapeutic use
Clinical trials
Drug-Related Side Effects and Adverse Reactions
Female
Humans
Hyperthermia, Induced
Infections
Infectious Diseases/Neglected Tropical Diseases
Infectious Diseases/Tropical and Travel-Associated Diseases
Injections, Intravenous
Leishmania major - drug effects
Leishmania major - radiation effects
Leishmaniasis, Cutaneous - drug therapy
Leishmaniasis, Cutaneous - therapy
Male
Middle Aged
Military personnel
Parasitic diseases
Treatment Outcome
Tropical diseases
Young Adult
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Description
Summary:Cutaneous Leishmania major has affected many travelers including military personnel in Iraq and Afghanistan. Optimal treatment for this localized infection has not been defined, but interestingly the parasite is thermosensitive. Participants with parasitologically confirmed L. major infection were randomized to receive intravenous sodium stibogluconate (SSG) 20mg/kg/day for ten doses or localized ThermoMed (TM) device heat treatment (applied at 50 degrees C for 30 seconds) in one session. Those with facial lesions, infection with other species of Leishmania, or more than 20 lesions were excluded. Primary outcome was complete re-epithelialization or visual healing at two months without relapse over 12 months. Fifty-four/56 enrolled participants received intervention, 27 SSG and 27 TM. In an intent to treat analysis the per subject efficacy at two months with 12 months follow-up was 54% SSG and 48% TM (p = 0.78), and the per lesion efficacy was 59% SSG and 73% TM (p = 0.053). Reversible abdominal pain/pancreatitis, arthralgias, myalgias, headache, fatigue, mild cytopenias, and elevated transaminases were more commonly present in the SSG treated participants, whereas blistering, oozing, and erythema were more common in the TM arm. Skin lesions due to L. major treated with heat delivered by the ThermoMed device healed at a similar rate and with less associated systemic toxicity than lesions treated with intravenous SSG. ClinicalTrials.gov NCT 00884377.
ISSN:1935-2735
1935-2727
1935-2735
DOI:10.1371/journal.pntd.0000628