Data Entry: Please note that the research database will be replaced by UNIverse by the end of October 2023. Please enter your data into the system https://universe-intern.unibas.ch. Thanks

Login for users with Unibas email account...

Login for registered users without Unibas email account...

 
Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial
JournalArticle (Originalarbeit in einer wissenschaftlichen Zeitschrift)
 
ID 4663714
Author(s) Welsche, S.; Mrimi, E. C.; Hattendorf, J.; Hürlimann, E.; Ali, S. M.; Keiser, J.
Author(s) at UniBasel Welsche, Sophie
Mrimi, Emmanuel
Hattendorf, Jan
Hürlimann, Eveline
Keiser, Jennifer
Year 2023
Title Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial
Journal The Lancet infectious diseases
Volume 23
Number 3
Pages / Article-Number 331-340
Mesh terms Animals; Adolescent; Humans; Albendazole, therapeutic use; Ivermectin, therapeutic use; Anthelmintics, therapeutic use; Trichuris; Tanzania, epidemiology; Feces, parasitology
Abstract BACKGROUND: Control efforts against soil-transmitted helminths focus on preventive chemotherapy with albendazole and mebendazole, however these drugs yield unsatisfactory results against Trichuris trichiura infections. We aimed to assess the efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole against T trichiura in adolescents living on Pemba Island, Tanzania. METHODS: This open-label, non-inferiority, randomised, controlled, phase 2/3 trial was done in four secondary schools (Kilindi, Kwale, Ndagoni [Chake Chake District], and Kiuyu [Wete District]) on Pemba Island, Tanzania. Adolescents aged 12-19 years who tested positive for T trichiura in at least two of four Kato-Katz slides with a mean infection intensity of 48 eggs per gram (EPG) of stool or higher were considered for inclusion. Participants were randomly assigned (21:21:2:2:8) to five treatment groups (8 mg moxidectin and 400 mg albendazole [group 1], 200 mug/kg ivermectin and 400 mg albendazole [group 2], 400 mg albendazole [group 3], 200 mug/kg ivermectin [group 4], or 8 mg moxidectin [group 5]) using a computer-generated randomisation code, stratified by baseline T trichiura infection intensity. Study site investigators and participants were not masked to study treatment; however, allocation was concealed to participants. The primary outcome was egg reduction rate (ERR) of T trichiura 14-21 days after treatment in the available case population. Moxidectin and albendazole was considered non-inferior to ivermectin and albendazole (control group) when the lower limit of the two-sided 95% CI of the difference was higher than the non-inferiority margin of -2 percentage points. This study is registered with ClinicalTrials.gov, NCT04700423. FINDINGS: Between March 1 and April 30, 2021, 771 participants were assessed for eligibility. 221 (29%) of 771 participants were ineligible and a further 14 (2%) were excluded. 207 (39%) of 536 participants were randomly assigned to moxidectin and albendazole, 211 (39%) to ivermectin and albendazole, 19 (4%) to albendazole, 19 (4%) to ivermectin, and 80 (15%) to moxidectin. Primary outcome data were available for all 536 participants. The geometric mean ERR of T trichiura after 14-21 days was 96.8% (95% CI 95.8 to 97.6) with moxidectin and albendazole and 99.0% (98.7 to 99.3) with ivermectin and albendazole (difference of -2.2 percentage points [-4.2 to -1.4]). No serious adverse events were reported during the study. The most reported adverse events were headache (160 [34%] of 465), abdominal pain (78 [17%]), itching (44 [9%]), and dizziness (26 [6%]). INTERPRETATION: Our findings show inferiority of moxidectin and albendazole to ivermectin and albendazole against T trichiura. However, given the high efficacy, moxidectin coadministration might complement treatment progammes, particularly in areas in which ivermectin is not available FUNDING: Bill and Melinda Gates Foundation, reference number OPP1153928.
ISSN/ISBN 1473-3099
URL https://doi.org/10.1016/S1473-3099(22)00589-8
edoc-URL https://edoc.unibas.ch/93874/
Full Text on edoc Available
Digital Object Identifier DOI 10.1016/S1473-3099(22)00589-8
PubMed ID http://www.ncbi.nlm.nih.gov/pubmed/36354034
Document type (ISI) Randomized Controlled Trial, Journal Article
 
   

MCSS v5.8 PRO. 0.323 sec, queries - 0.000 sec ©Universität Basel  |  Impressum   |    
19/06/2024