Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network...

Area of Science:

• Tropical medicine
• Infectious diseases
• Clinical trial methodology

Background:

• Treatment of cutaneous leishmaniasis (CL) is hindered by inconsistent research methodologies.
• Existing systematic reviews show weak evidence for current CL treatment recommendations.
• Lack of standardized trial parameters affects Old-World CL (OWCL) and New-World CL (NWCL) research.

Purpose of the Study:

• To achieve consensus on core eligibility and outcome measures for CL treatment trials.
• To standardize clinical research methodologies across OWCL and NWCL.
• To facilitate the development of a robust consortium for CL research.

Main Methods:

• A previously published guidance paper on CL trial methodology was used as a reference.
• Two separate meetings were held to seek consensus among OWCL and NWCL trial sites.
• Consensus was sought on key parameters including core eligibility and outcome measures.

Main Results:

• Findings and consensus levels within and between OWCL and NWCL sites are presented.
• CL trial site characteristics and capacities were summarized.
• Consensus was reached on essential parameters for future CL clinical research.

Conclusions:

• The achieved consensus enables standardization of future clinical research across OWCL and NWCL sites.
• Researchers are encouraged to adopt and adapt the proposed parameters and outcomes.
• Standardized assessment of interventions can lead to faster approval of candidate CL treatments.