Dataset Information

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.

ABSTRACT:

Background

Cutaneous leishmaniasis (CL) is a neglected infectious disease and a major health problem in several developing countries. Despite some reasonable explanation for their potential benefits, there is only trace evidence regarding the role of dressings in the treatment of CL.

Methods

This randomized, assessor-blind, controlled, clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intralesional meglumine antimoniate (i.l.MA) either alone or combined with application of a silver or a non-silver polyester dressing on their lesions for 6 weeks. After screening of 241 patients with CL lesions, 83 eligible patients with 158 lesions were randomly allocated in three arms of the study. Eligibility criteria included parasitologically confirmed CL, age of 12 to 60 years; willingness to participate, duration of lesion<3 months, number of lesions<5, largest ulcer diameter<5 cm. Pregnant or lactating women were excluded. The primary outcome was absolute risk reduction (ARR) based on the proportion of complete healing, which was defined as more than 75% reduction in the size of the lesion compared with baseline in each group at the termination of treatment and 1 month later.

Findings

ARR (95% Confidence Interval [CI]) in i.l.MA versus i.l.MA+non-silver dressing groups was 5.98% (-7.07% to 20.25%), between i.l.MA versus i.l.MA+silver dressing groups was -0.23% (-13.53% to 14.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was -6.21%(-18.28% to 6.52%) after 6 weeks of treatment. ARR (95% CI) in i.l.MA versus i.l.MA+non-silver dressing groups was -2.22% (-22.12% to 18.10%), between i.l.MA versus i.l.MA+silver dressing groups was 3.64% (-15.36% to 22.82%), and between i.l.MA+non-silver dressing versus i.l.MA+silver dressing groups was 5.86% (-12.86% to 24.31%) 1 month later.

Conclusion

It could not be demonstrated that the efficacy of i.l.MA was improved by either dressing.

Trial registration

Iranian Registry of Clinical Trials (IRCT.ir) IRCT138707201166N2.

SUBMITTER: Khatami A

PROVIDER: S-EPMC3691234 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Publications

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.

Khatami Alireza A Talaee Rezvan R Rahshenas Makan M Khamesipour Ali A Mehryan Pedram P Tehrani Sepideh S Dowlati Yahya Y Firooz Alireza A

PloS one 20130624 6

<h4>Background</h4>Cutaneous leishmaniasis (CL) is a neglected infectious disease and a major health problem in several developing countries. Despite some reasonable explanation for their potential benefits, there is only trace evidence regarding the role of dressings in the treatment of CL.<h4>Methods</h4>This randomized, assessor-blind, controlled, clinical trial was conducted in an endemic area for CL caused by Leishmania major in Iran to assess the efficacy of administration of weekly intral ...[more]

PMID: 23826087

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Project description:Cutaneous Leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis.A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for Leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be daily administered and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

Project description:BackgroundOral miltefosine has been shown to be non-inferior to first-line, injectable meglumine antimoniate (MA) for the treatment of cutaneous leishmaniasis (CL) in children. Miltefosine may be administered via in-home caregiver Directly Observed Therapy (cDOT), while patients must travel to clinics to receive MA. We performed a cost-effectiveness analysis comparing miltefosine by cDOT versus MA for pediatric CL in southwest Colombia.Methodology/principle findingsWe developed a Monte Carlo model comparing the cost-per-cure of miltefosine by cDOT compared to MA from patient, government payer, and societal perspectives (societal = sum of patient and government payer perspective costs). Drug effectiveness and adverse events were estimated from clinical trials. Healthcare utilization and costs of travel were obtained from surveys of providers and published sources. The primary outcome was cost-per-cure reported in 2015 USD. Treatment efficacy, costs, and adherence were varied in sensitivity analysis to assess robustness of results. Treatment with miltefosine resulted in substantially lower cost-per-cure from a societal and patient perspective, and slightly higher cost-per-cure from a government payer perspective compared to MA. Mean societal cost-per-cure were $531 (SD±$239) for MA and $188 (SD±$100) for miltefosine, a mean cost-per-cure difference of +$343. Mean cost-per-cure from a patient perspective were $442 (SD ±$233) for MA and $30 (SD±$16) for miltefosine, a mean difference of +$412. Mean cost-per-cure from a government perspective were $89 (SD±$55) for MA and $158 (SD±$98) for miltefosine, with a mean difference of -$69. Results were robust across a variety of assumptions in univariate and multi-way analysis.Conclusions/significanceTreatment of pediatric cutaneous leishmaniasis with miltefosine via cDOT is cost saving from patient and societal perspectives, and moderately more costly from the government payer perspective compared to treatment with MA. Results were robust over a range of sensitivity analyses. Lower drug price for miltefosine could result in cost saving from a government perspective.

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Dataset Information

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.

Background

Methods

Findings

Conclusion

Trial registration

Publications

Dressings combined with injection of meglumine antimoniate in the treatment of cutaneous leishmaniasis: a randomized controlled clinical trial.

Similar Datasets

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