دورية أكاديمية
A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambaréné and surroundings.
| العنوان: | A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambaréné and surroundings. |
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| المؤلفون: | Nguema Moure PA; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Ecole Doctorale Régionale d'Afrique Centrale en Infectiologie Tropicale de Franceville, Franceville, Gabon., Nzamba Maloum M; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Manouana GP; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany., Laclong Lontchi R-A; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Mbong Ngwese M; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Edoa JR; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Fréjus Zinsou J; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany., Meulah B; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands., Mahmoudou S; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., N'noh Dansou EM; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Josiane Honkpehedji Y; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands., Romeo Adegbite B; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany., Agnandji ST; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany.; German Center for Infection Research (DZIF), Tübingen, Germany., Ramharter M; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Department of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I. Dep. of Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Lell B; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Division of Infectious Diseases and Tropical Medicine, Department of Medicine 1, Medical University of Vienna, Vienna, Austria., Borrmann S; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany.; German Center for Infection Research (DZIF), Tübingen, Germany., Kremsner PG; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany.; German Center for Infection Research (DZIF), Tübingen, Germany., Dejon-Agobé JC; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon., Adegnika AA; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.; Ecole Doctorale Régionale d'Afrique Centrale en Infectiologie Tropicale de Franceville, Franceville, Gabon.; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Universität Tübingen, Tübingen, Germany.; Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands.; German Center for Infection Research (DZIF), Tübingen, Germany. |
| المصدر: | Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2024 May 02; Vol. 68 (5), pp. e0121123. Date of Electronic Publication: 2024 Apr 02. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| 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: | Albendazole*/therapeutic use , Albendazole*/adverse effects , Albendazole*/administration & dosage , Mebendazole*/therapeutic use , Trichuriasis*/drug therapy , Trichuris*/drug effects , Anthelmintics*/therapeutic use , Anthelmintics*/adverse effects , Anthelmintics*/administration & dosage , Pyrantel*/therapeutic use, Humans ; Child ; Male ; Female ; Animals ; Child, Preschool ; Adolescent ; Drug Therapy, Combination ; Treatment Outcome ; Parasite Egg Count |
| مستخلص: | Helminthiasis remains a public health issue in endemic areas. Various drugs have been proposed to improve efficacy against helminths. The study aimed to assess the safety and efficacy of three different anthelmintic combinations to treat Trichuris trichiura infections. We conducted a randomized assessors-blind clinical trial involving children aged 2-17 years with T. trichiura . Participants were randomly assigned to one of three treatment arms. On the first and third days, all participants got albendazole 400 mg, and on the second day, albendazole (arm A), mebendazole 500 mg (arm B), or pyrantel 125 mg/kg (arm C). We assessed treatment efficacy using the cure rate (CR) and egg reduction rate (ERR) at 3 and 6 weeks post-treatment. At 3 weeks post-treatment, ERR and CR were highest in study arm A [ERR = 94%, 95% confidence interval (CI): 92-95; CR = 71%; 95% CI: 58-81] compared to the B and C arms. Decrease in ERR was significant only for arm B versus arm A ( P -value <0.001); decrease in ERR was significant for arms B and C ( P -value <0.001). No statistical difference was observed in CR when comparing arms A and B ( P -value =1.00) and C ( P -value =0.27). At 6 weeks, a decrease in ERR was observed in three arms, significant only for arm C, 81% (95% CI: 78-83). A significant increase in egg counts was observed between 3 and 6 weeks post-treatment. All treatments were safe with mild adverse events. Albendazole 400 mg/day (arm A) showed the highest efficacy against trichuriasis. Nonetheless, this treatment regimen was able to cure half of the treated individuals highlighting concerns about controlling the transmission of T. trichiura .CLINICAL TRIALRegistered at ClinicalTrials.gov (NCT04326868). Competing Interests: The authors declare no conflict of interest. |
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| معلومات مُعتمدة: | KfW Entwicklungsbank (KfW Development Bank); Bundesministerium für Wirtschaftliche Zusammenarbeit und Entwicklung (BMZ); Deutsches Zentrum für Infektionsforschung (DZIF) |
| فهرسة مساهمة: | Keywords: Trichuris trichiura; albendazole; benzimidazole combination; coinfection; efficacy; mebendazole; pyrantel; safety; trichuriasis |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04326868 |
| المشرفين على المادة: | F4216019LN (Albendazole) 81G6I5V05I (Mebendazole) 0 (Anthelmintics) 4QIH0N49E7 (Pyrantel) |
| تواريخ الأحداث: | Date Created: 20240402 Date Completed: 20240502 Latest Revision: 20240614 |
| رمز التحديث: | 20240615 |
| مُعرف محوري في PubMed: | PMC11064543 |
| DOI: | 10.1128/aac.01211-23 |
| PMID: | 38563751 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1098-6596 |
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| DOI: | 10.1128/aac.01211-23 |