دورية أكاديمية
أعرض في EDS

Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo.

التفاصيل البيبلوغرافية
العنوان: Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo.
المؤلفون: Kuemmerle A; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Basel, Switzerland., Schmid C; Swiss Tropical and Public Health Institute, Basel, Switzerland.; University of Basel, Basel, Switzerland., Kande V; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo., Mutombo W; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo.; DNDi, Geneva, Switzerland., Ilunga M; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo., Lumpungu I; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo., Mutanda S; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo., Nganzobo P; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo., Ngolo D; Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Democratic Republic of the Congo.; DNDi, Geneva, Switzerland., Kisala M; Bureau Diocesain d'Oeuvres Medicales, Kikwit, Democratic Republic of the Congo., Valverde Mordt O; DNDi, Geneva, Switzerland.
المصدر: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2020 Jan 27; Vol. 14 (1), pp. e0008028. Date of Electronic Publication: 2020 Jan 27 (Print Publication: 2020).
نوع المنشور: Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Trypanosoma brucei gambiense*, Eflornithine/*therapeutic use , Nifurtimox/*therapeutic use , Trypanocidal Agents/*therapeutic use , Trypanosomiasis, African/*drug therapy, Democratic Republic of the Congo/epidemiology ; Drug Therapy, Combination ; Eflornithine/administration & dosage ; Humans ; Nifurtimox/administration & dosage ; Treatment Outcome ; Trypanosomiasis, African/epidemiology
مستخلص: Background: Nifurtimox eflornithine combination therapy (NECT) to treat human African trypanosomiasis (HAT), commonly called sleeping sickness, was added to the World Health Organisation's (WHO) Essential Medicines List in 2009 and to the Paediatric List in 2012. NECT was further tested and documented in a phase IIIb clinical trial in the Democratic Republic of Congo (DRC) assessing the safety, effectiveness, and feasibility of implementation under field conditions (NECT-FIELD study). This trial brought a unique possibility to examine concomitant drug management.
Methodology/principal Findings: This is a secondary analysis of the NECT-FIELD study where 629 second stage gambiense HAT patients were treated with NECT, including children and pregnant and breastfeeding women in six general reference hospitals located in two provinces. Concomitant drugs were prescribed by the local investigators as needed. Patients underwent daily evaluations, including vital signs, physical examination, and adverse event monitoring. Concomitant medication was documented from admission to discharge. Patients' clinical profiles on admission and safety profile during specific HAT treatment were similar to previously published reports. Prescribed concomitant medications administered during the hospitalization period, before, during, and immediately after NECT treatment, were mainly analgesics/antipyretics, anthelmintics, antimalarials, antiemetics, and sedatives. Use of antibiotics was reasonable and antibiotics were often prescribed to treat cellulitis and respiratory tract infections. Prevention and treatment of neurological conditions such as convulsions, loss of consciousness, and coma was used in approximately 5% of patients.
Conclusions/significance: The prescription of concomitant treatments was coherent with the clinical and safety profile of the patients. However, some prescription habits would need to be adapted in the future to the evolving available pharmacopoeia. A list of minimal essential medication that should be available at no cost to patients in treatment wards is proposed to help the different actors to plan, manage, and adequately fund drug supplies for advanced HAT infected patients.
Trial Registration Number: The initial study was registered at ClinicalTrials.gov, number NCT00906880.
Competing Interests: The authors have declared that no competing interests exist.
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سلسلة جزيئية: ClinicalTrials.gov NCT00906880
المشرفين على المادة: 0 (Trypanocidal Agents)
M84I3K7C2O (Nifurtimox)
ZQN1G5V6SR (Eflornithine)
تواريخ الأحداث: Date Created: 20200128 Date Completed: 20200403 Latest Revision: 20231113
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC7004379
DOI: 10.1371/journal.pntd.0008028
PMID: 31986140
قاعدة البيانات: MEDLINE
الوصف
تدمد:1935-2735
DOI:10.1371/journal.pntd.0008028