Randomized, Double-Blinded, Phase 2 Trial of WR 279,396 (Paromomycin and Gentamicin) for Cutaneous Leishmaniasis in Panama
| Autor: | José E. Calzada, William F. McCarthy, Melissa Nieto, Nestor Sosa, Mara Kreishman-Deitrick, Max Grogl, Zeuz Capitán, Charles Scott, Judith Berman, Karen M. Kopydlowski, Janet Ransom, Javier Nieto, Hector Paz, Carmenza Spadafora, Diane Ullman |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
business.industry Phases of clinical research Paromomycin Leishmaniasis Articles medicine.disease Gastroenterology law.invention Surgery carbohydrates (lipids) Infectious Diseases Pharmacotherapy Randomized controlled trial Cutaneous leishmaniasis law Virology Internal medicine parasitic diseases medicine Parasitology Gentamicin Adverse effect business medicine.drug |
| Zdroj: | The American Journal of Tropical Medicine and Hygiene |
| ISSN: | 1476-1645 0002-9637 |
| DOI: | 10.4269/ajtmh.12-0736 |
| Popis: | In this randomized, double-blinded Phase 2 trial, 30 patients with Leishmania panamensis cutaneous leishmaniasis were randomly allocated (1:1) to receive once daily topical treatment with WR 279,396 (15% paromomycin + 0.5% gentamicin) or Paromomycin Alone (15% paromomycin) for 20 days. The index lesion cure rate after 6 months follow-up was 13 of 15 (87%) for WR 279,396 and 9 of 15 (60%) for Paromomycin Alone (P = 0.099). When all treated lesions were included, the final cure rate for WR 279,398-treated patients was again 87%, but the final cure rate for Paromomycin Alone-treated patients was 8 of 15 (53.3%; P = 0.046). Both creams were well tolerated with mild application site reactions being the most frequent adverse event. The increased final cure rate in the WR 279,396 group in this small Phase 2 study suggests that the combination product may provide greater clinical benefit than paromomycin monotherapy against L. panamensis cutaneous leishmaniasis. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|