Randomised, open label, multicentre clinical non-inferiority trial for new treatment modalities for cutaneous leishmaniasis caused by Leishmania tropica in Pakistan
Principal investigator
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Location
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Topic
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Methodology
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ReferenceOCA018-59
Purpose of study
Purpose of study
Evaluate alternative treatments modalities by comparing oral miltefosine mono-therapy, local thermotherapy, and a combination of local thermotherapy plus oral miltefosine with the standard of care of meglumine antimoniate injections in a non-infer...
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Concept
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Protocol & ERB
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Implementation
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Completion
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Archived
Study timeline
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ERB documentation added by Koert Ritmeijer
16th September 2020NBC-378_Y2_Extension_Approval_Letter_16.09.2020.pdf73 KB -
ERB documentation added by Koert Ritmeijer
16th March 2020NBC_378_Approval_Letter_19.06.2019.pdf270 KB -
ERB documentation added by Koert Ritmeijer
16th March 20201902_MSFERB_Approval_12July2019.pdf572 KB -
Scientific meeting dissemination added by Koert Ritmeijer
25th October 2019Poster presentation on ECTMIH 2019, Liverpool, UK: "Randomised, open label, multicentre non-inferiority clinical trial for new treatment modalities for cutaneous leishmaniasis caused by L. tropica Pakistan"
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ERB supporting documents added by Koert Ritmeijer
25th October 2019MTA_Species_Identification-CL_study_Quaid-I-Azam..pdf4.33 MB -
ERB supporting documents added by Koert Ritmeijer
25th October 20192019-1073_MSF_AMC_FINAL_SIGNED.pdf540 KB -
ERB documentation added by Koert Ritmeijer
25th October 2019NBC_378_Approval_Letter_19.06.2019.pdf270 KB -
ERB documentation added by Koert Ritmeijer
25th October 20191902_MSFERB_Approval_12July2019.pdf572 KB -
Protocol added by Koert Ritmeijer
24th October 20192019_07_03_CL_Study_Protocol_RCT_Pakistan_vs_5_FINAL_CLEAN.pdf1.38 MB -
Concept paper added
24th January 20192018_CN_RCT_Miltefosine-Thermotherapy_CL_Pakistan_KR.docx71.2 KB
Documents
Publications
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