دورية أكاديمية
Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease: Results at 4-Year Follow-Up in a Prospective, Historically Controlled Study (CHICO SECURE).
| العنوان: | Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease: Results at 4-Year Follow-Up in a Prospective, Historically Controlled Study (CHICO SECURE). |
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| المؤلفون: | Altcheh J; Parasitología, Hospital de Niños Ricardo Gutiérrez and Instituto Multidisciplinario de Investigacion en Patologias Pediatricas (IMIPP), CONICET-GCBA, Buenos Aires, Argentina., Sierra V; Centro de Atención e Investigación Médica S.A., Yopal, Colombia., Ramirez T; Centro de Enfermedad de Chagas y Patologias Regionales, Santiago del Estero, Argentina., Pinto Rocha JJ; Fundación CEADES-Plataforma de Atención Integral a los Pacientes con Enfermedades de Chagas, Cochabamba, Bolivia., Grossmann U; Bayer AG, Research and Development Pharmaceuticals, Berlin, Germany., Huang E; Bayer US LLC, Whippany, New Jersey, USA., Moscatelli G; Parasitología, Hospital de Niños Ricardo Gutiérrez and Instituto Multidisciplinario de Investigacion en Patologias Pediatricas (IMIPP), CONICET-GCBA, Buenos Aires, Argentina., Ding O; Bayer HealthCare Co., Ltd., Shanghai, China. |
| المصدر: | Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2023 Apr 18; Vol. 67 (4), pp. e0119322. Date of Electronic Publication: 2023 Mar 28. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society for Microbiology Country of Publication: United States NLM ID: 0315061 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1098-6596 (Electronic) Linking ISSN: 00664804 NLM ISO Abbreviation: Antimicrob Agents Chemother Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Washington, American Society for Microbiology |
| مواضيع طبية MeSH: | Trypanocidal Agents*/adverse effects , Chagas Disease*/drug therapy , Nitroimidazoles*/adverse effects, Humans ; Child ; Adolescent ; Nifurtimox/adverse effects ; Follow-Up Studies ; Prospective Studies ; Historically Controlled Study ; Treatment Outcome ; Body Weight |
| مستخلص: | Nifurtimox is recommended for the treatment of Chagas disease; however, long-term follow-up data are scarce. This prolonged follow-up phase of the prospective, historically controlled, CHICO clinical trial evaluated seronegative conversion in pediatric patients aged <18 years with Chagas disease who were followed for 4 years after nifurtimox treatment. Patients were randomly assigned 2:1 to nifurtimox 60-day or 30-day regimens comprising 10 to 20 mg/kg/day for patients aged <12 years and body weight <40 kg, and 8 to 10 mg/kg/day for those aged ≥12 years and body weight ≥40 kg. Anti-Trypanosoma cruzi antibodies decreased during the study period, achieving seronegative conversion in 16 (8.12%) and 8 (8.16%) patients in the 60-day and 30-day nifurtimox regimens, respectively, with corresponding incidence rates per 100 patients/year of seronegative conversion of 2.12 (95% confidence interval [CI]: 1.21 to 3.45) and 2.11 (95% CI: 0.91 to 4.16). Superiority of the 60-day nifurtimox regimen was confirmed by the lower limit of the 95% CI being higher than that (0%) in a historical placebo control group. Children aged <2 years at baseline were more likely to reach seronegative conversion during the 4-year follow-up than older children. At any annual follow-up visit, >90% of evaluable patients had persistently negative quantitative PCR results for T. cruzi DNA. No adverse events potentially related to treatment or caused by protocol-required procedures were documented for either treatment regimen. This study confirms the effectiveness and safety of a pediatric formulation of nifurtimox administered in an age- and weight-adjusted regimen for 60 days to treat children with Chagas disease. |
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| فهرسة مساهمة: | Keywords: Chagas disease; Trypanosoma cruzi; follow-up; nifurtimox; pediatrics; seronegative conversion; treatment |
| سلسلة جزيئية: | ClinicalTrials.gov NCT02625974 |
| المشرفين على المادة: | M84I3K7C2O (Nifurtimox) 0 (Trypanocidal Agents) 0 (Nitroimidazoles) |
| تواريخ الأحداث: | Date Created: 20230328 Date Completed: 20230420 Latest Revision: 20230421 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10112190 |
| DOI: | 10.1128/aac.01193-22 |
| PMID: | 36975790 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1098-6596 |
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| DOI: | 10.1128/aac.01193-22 |