NCT03435419 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Alvar J, Vélez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, den Boer M; WHO Leishmaniasis Control Team
Leishmaniasis worldwide and global estimates of its incidence. PLoS One. 2012;7(5):e35671. doi: 10.1371/journal.pone.0035671. Epub 2012 May 31.
De Silva G, Somaratne V, Senaratne S, Vipuladasa M, Wickremasinghe R, Wickremasinghe R, Ranasinghe S
Efficacy of a new rapid diagnostic test kit to diagnose Sri Lankan cutaneous leishmaniasis caused by Leishmania donovani. PLoS One. 2017 Nov 14;12(11):e0187024. doi: 10.1371/journal.pone.0187024. eCollection 2017.
Eroglu F, Uzun S, Koltas IS
Comparison of clinical samples and methods in chronic cutaneous leishmaniasis. Am J Trop Med Hyg. 2014 Nov;91(5):895-900. doi: 10.4269/ajtmh.13-0582. Epub 2014 Sep 15.
Marfurt J, Nasereddin A, Niederwieser I, Jaffe CL, Beck HP, Felger I
Identification and differentiation of Leishmania species in clinical samples by PCR amplification of the miniexon sequence and subsequent restriction fragment length polymorphism analysis. J Clin Microbiol. 2003 Jul;41(7):3147-53.
Masmoudi A, Hariz W, Marrekchi S, Amouri M, Turki H
Old World cutaneous leishmaniasis: diagnosis and treatment. J Dermatol Case Rep. 2013 Jun 30;7(2):31-41. doi: 10.3315/jdcr.2013.1135. Print 2013 Jun 30.
Notomi T, Okayama H, Masubuchi H, Yonekawa T, Watanabe K, Amino N, Hase T
Loop-mediated isothermal amplification of DNA. Nucleic Acids Res. 2000 Jun 15;28(12):E63.
Reithinger R, Dujardin JC, Louzir H, Pirmez C, Alexander B, Brooker S
Cutaneous leishmaniasis. Lancet Infect Dis. 2007 Sep;7(9):581-96. Review.

Point of Care Tests for Cutaneous Leishmaniasis: Prospective Evaluation of LoopampTM and CL DetectTM Rapid Test for Cutaneous Leishmaniasis Diagnosis in Afghanistan

Details for clinical trial NCT03435419

Clinical trial NCT03435419 - References