Academic Journal
PKDL Sudan Study Synopsis.
| العنوان: | PKDL Sudan Study Synopsis. |
|---|---|
| المؤلفون: | Brima Musa Younis, Ahmed Mudawi Musa, Séverine Monnerat, Mohammed Abdelrahim Saeed, Eltahir Awad Gasim Khalil, Anas Elbashir Ahmed, Mujahid Ahmed Ali, Ali Noureldin, Gina Muthoni Ouattara, Godfrey M. Nyakaya, Samuel Teshome, Truphosa Omollo, Michael Ochieng, Thaddaeus Egondi, Mildred Mmbone, Wan-Yu Chu, Thomas P. C. Dorlo, Eduard E. Zijlstra, Monique Wasunna, Jorge Alvar, Fabiana Alves |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Medicine, Pharmacology, Biotechnology, Cancer, Infectious Diseases, Virology, Computational Biology, liposomal amphotericin b, future vl elimination, either daily intra, azar dermal leishmaniasis, 2 %, 3 &# 8211, 2 &# 8211, 0 %, 110 patients completed, 0 &# 8211, actual treatment received, grade 3 pkdl, least one dose, plus oral miltefosine, mf &# 8211, additional pkdl treatment, randomized patients receiving, currently recommended 60, 6 %) patients, 12 years old, |
| Time: | 95 |
| الوصف: | Background Treatment for post-kala-azar dermal leishmaniasis (PKDL) in Sudan is currently recommended only for patients with persistent or severe disease, mainly because of the limitations of current therapies, namely toxicity and long hospitalization. We assessed the safety and efficacy of miltefosine combined with paromomycin and liposomal amphotericin B (LAmB) for the treatment of PKDL in Sudan. Methodology/principal findings An open-label, phase II, randomized, parallel-arm, non-comparative trial was conducted in patients with persistent (stable or progressive disease for ≥ 6 months) or grade 3 PKDL, aged 6 to ≤ 60 years in Sudan. The median age was 9.0 years (IQR 7.0–10.0y) and 87% of patients were ≤12 years old. Patients were randomly assigned to either daily intra-muscular paromomycin (20mg/kg, 14 days) plus oral miltefosine (allometric dose, 42 days)–PM/MF–or LAmB (total dose of 20mg/kg, administered in four injections in week one) and oral miltefosine (allometric dose, 28 days)–LAmB/MF. The primary endpoint was a definitive cure at 12 months after treatment onset, defined as clinical cure (100% lesion resolution) and no additional PKDL treatment between end of therapy and 12-month follow-up assessment. 104/110 patients completed the trial. Definitive cure at 12 months was achieved in 54/55 (98.2%, 95% CI 90.3–100) and 44/55 (80.0%, 95% CI 70.2–91.9) of patients in the PM/MF and AmB/MF arms, respectively, in the mITT set (all randomized patients receiving at least one dose of treatment; in case of error of treatment allocation, the actual treatment received was used in the analysis). No SAEs or deaths were reported, and most AEs were mild or moderate. At least one adverse drug reaction (ADR) was reported in 13/55 (23.6%) patients in PM/MF arm and 28/55 (50.9%) in LAmB/MF arm, the most frequent being miltefosine-related vomiting and nausea, and LAmB-related hypokalaemia; no ocular or auditory ADRs were reported. Conclusions/significance The PM/MF regimen requires shorter hospitalization than the currently ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| Relation: | https://figshare.com/articles/journal_contribution/PKDL_Sudan_Study_Synopsis_/24601627 |
| DOI: | 10.1371/journal.pntd.0011780.s002 |
| الاتاحة: | https://doi.org/10.1371/journal.pntd.0011780.s002 https://figshare.com/articles/journal_contribution/PKDL_Sudan_Study_Synopsis_/24601627 |
| Rights: | CC BY 4.0 |
| رقم الانضمام: | edsbas.BAB08A1F |
| قاعدة البيانات: | BASE |
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