Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

Abstract

IntroductionProgress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL).Materials and methodsUsing a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings.ResultsFindings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized.ConclusionsThe consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments.

Patients’ preferences of cutaneous leishmaniasis treatment outcomes: Findings from an international qualitative study

“…The purpose of this study is to present findings relating to OWCL and NWCL patients' expectations on desired treatment outcomes as part of a large multi-centre qualitative study exploring patients' perceptions and understanding of CL. This will complement the consensus reached among the clinical research communities [10,11]. Together, these comprehensive approaches are intended to improve the design of interventions and the way these are assessed, so as to achieve better care for neglected populations affected by CL.…”

“…Relapse, contained in the domain Recurrence, is addressed in trials, but at varying time points [2][3][4]6]. In line with Olliaro et al [11], we would recommend to consistently include six months (180 days) follow up to assess final cure. Taking into consideration potentially increased costs and the probability of loss to follow-up, this would be particularly recommended for phase IV and/or post-licensing surveillance studies.…”

“…The survey questionnaire will combine outcomes reported in the literature with outcomes reported during this study and recommended for inclusion in clinical trials. The aim of this study is the development of a COS for CL, consisting of a consensus set of proposed outcomes and their measurement instruments recommended for inclusion in future clinical trials, therefore working towards harmonization of clinical trial methodology and including patients' voices (11).…”

“…Progress has been made in addressing these shortcomings through reaching consensus across the OWCL and NWCL researchers' community on critical aspects of clinical trial methodologies for CL [10,11], however, patients' views have not yet been genuinely considered, especially regarding treatment outcomes. Trials conducted so far emphasize clinical and Austrian Academy of Sciences (www.oeaw.ac.at/ en/) at the Nuffield Department of Medicine, University of Oxford.…”

Comparing spatio‐temporal distribution of the most common human parasitic infections in Iran over two periods 2007 to 2012 and 2013 to 2018: A systematic quantitative literature review

“…5 CL occurs predominantly in seven countries: Algeria, Brazil, Peru, Afghanistan, Saudi Arabia, Syria and Iran, which comprise 90% of the 5.1 million new cases recorded per year in the world. 6 The infection involves 17 of Iran's 31 provinces and the total annual incidence rate is about 20 000 cases. 7 Human toxoplasmosis is caused by Toxoplasma gondii, which is one of the most common public health problems that contaminates one-third of the human population at all times around the world.…”