title: Effectiveness of Short-Course Meglumine Antimoniate (Glucantime®) for Treatment of Visceral Leishmaniasis: A 13-Year, Multistage, Non-Inferiority Study in Iran.
abstract: The World Health Organization's (WHO) recommendation is 28-day course of meglumine antimoniate (Glucantime®, Sanofi Aventis, France) for the treatment of visceral leishmaniasis (VL). The aim of this study was to evaluate the effectiveness of a shorter duration of treatment in regions with low level of resistance to Glucantime. During 13 years, this study was conducted in three phases on 392 patients. In the pilot first phase, we performed splenic punctures in seven patients to assess the correlation between the changes in the parasite load during treatment with Glucantime and defervescence. With defervescence, parasite density was dramatically dropped (P = 0.014), propounding defervescence as a marker of parasitological response. On the basis of the results, we conducted a randomized trial on 75 patients, comparing the efficacy of continuation of Glucantime therapy for 1, 2, or 3 weeks after defervescence. The treatment course of 1 week after defervescence (mean = 11.7 days) was non-inferior to that of 3 weeks (final cure rate, 96% versus 100%; P = 0.023). The third phase was a retrospective cohort study of 302 patients treated either with the WHO's regimen or for 7 days after defervescence (intervention group). Relapse was detected in 8.3% patients of the intervention group and in 5% patients following the WHO's regimen (P = 0.006 for non-inferiority). The final duration of treatment in intervention group was significantly shorter than standard course (13.3 ± 2.6 versus 28 days; P < 0.001). In summary, treatment of VL with Glucantime for 1 week after defervescence was non-inferior to and appears to be an acceptable alternative to the standard 28-day course for patients in Iran who show a response to antimonial therapy.
authors.affiliation: Professor Alborzi Clinical Microbiology Research Center, Department of Paediatrics, Nemazee Teaching Hospital, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Abdolvahab
authors.initials: A
authors.lastname: Alborzi
authors.affiliation: Professor Alborzi Clinical Microbiology Research Center, Department of Paediatrics, Nemazee Teaching Hospital, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. pouladfar_ghr@hotmail.com attarar@sums.ac.ir.
authors.forename: Gholamreza
authors.initials: G
authors.lastname: Pouladfar
authors.affiliation: Cardiovascular Research Center, TAHA Clinical Trial Group, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. pouladfar_ghr@hotmail.com attarar@sums.ac.ir.|Molecular Pathology Research Center, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.|Student Research Committee, Cell and Molecular Medicine Research Club, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Armin
authors.initials: A
authors.lastname: Attar
authors.affiliation: Student Research Committee, Fasa University of Medical Sciences, Fasa, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Falahi
authors.affiliation: Professor Alborzi Clinical Microbiology Research Center, Department of Paediatrics, Nemazee Teaching Hospital, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Zahra
authors.initials: Z
authors.lastname: Jafarpour
authors.affiliation: Pediatric Infectious Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Abdollah
authors.initials: A
authors.lastname: Karimi
authors.affiliation: Professor Alborzi Clinical Microbiology Research Center, Department of Paediatrics, Nemazee Teaching Hospital, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Mohammad Rahim
authors.initials: MR
authors.lastname: Kadivar
mesh_terms: D002675:Child, Preschool; D015331:Cohort Studies; D004334:Drug Administration Schedule; D006801:Humans; D007492:Iran / Q000453:epidemiology; D007898:Leishmaniasis, Visceral / Q000188:drug therapy*; D008536:Meglumine / Q000008:administration & dosage / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D012189:Retrospective Studies
chemical_list: D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate