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Safety of mass drug coadministration with ivermectin, diethylcarbamazine, albendazole, and azithromycin for the integrated treatment of neglected tropical diseases: a cluster randomized community trial
- Source :
- Lancet Reg Health West Pac, The Lancet Regional Health. Western Pacific, Vol 18, Iss, Pp 100293-(2022)
- Publication Year :
- 2022
- Publisher :
- Elsevier BV, 2022.
-
Abstract
- Summary: Introduction: Neglected tropical diseases control programmes run separately. For settings with more than one endemic disease, combined mass drug administration (MDA) has potential practical advantages compared with separate programmes but needs confirmation of safety. We assessed the safety of combined MDA for multiple neglected tropical diseases using ivermectin, diethylcarbamazine, albendazole (IDA) and azithromycin (AZI). Methods: We conducted an open-label, cluster-randomized trial involving individuals living in 34 wards (smaller administrative division) in two study sites, Namatanai District and Lihir Island, Papua New Guinea. We randomly assigned wards to the combined treatment arm (which received a single dose of the triple combination IDA and a single dose of AZI at the same visit) or the control arm (which received IDA separately followed by AZI separately one week after). All participants underwent safety assessments one day after drug administration. Methodology for collecting the adverse events (AEs) was a general question (in Namatanai) and individual questions about specific AEs (in Lihir). The primary endpoint was the prevalence of AEs. Safety of combined treatment was taken to be non-inferior to that of IDA if the upper limit of the two-sided CI for the difference in rates was equal or lower than 5%. Findings: The study enrolled 15,656 participants. Of those enrolled, 7,281 (46.3%) received the combined regimen and 8,375 (53.3%) received standard treatment with IDA for lymphatic filariasis between Nov 1, 2018, and Apr 15, 2019. Of the individuals in the control group, 4,228 (50.5%) attended a second visit one week apart to receive AZI for yaws. In Namatanai, the proportion of AEs was similar in the combined group (0.8%) compared to the IDA group (1.3%, difference 0.5% [95CI -2.5% to 1.4%]) or the AZI group (3.6%, d -2.8% [95CI -8.6% to 2.8%]). In Lihir, the proportion of AEs was higher in the combined group (23.0%) compared to the IDA group (12.2%, d 10.8% [95% CI 1.5% to 20.2%]) or the AZI group (11.1%, d 11.9% [95% CI 2.7% to 21.1%]).We observed 21 (0.3%) grade-2 AEs in the combined treatment group, 33 (0.4%) in the IDA separately group, and 18 (0.2%) in the AZI separately group. No participants required treatment for any AE. We observed no deaths, serious AEs, or AEs of special interest. Interpretation: In the largest trial so far involving coadministration of regimens based on IDA and AZI, the combination was safe and feasible in a population of more than 15,000 people. Combined MDA based on these two regimens opens up new potential for the control of neglected tropical diseases in the Western Pacific region. Funding: International Trachoma Initiative, “la Caixa” Foundation, Kern Pharma.
- Subjects :
- medicine.medical_specialty
Population
integration
Diethylcarbamazine
Albendazole
Internal medicine
Internal Medicine
medicine
Clinical endpoint
Adverse effect
education
lymphatic filariasis
Lymphatic filariasis
mass drug administration
education.field_of_study
business.industry
Health Policy
Standard treatment
yaws
Public Health, Environmental and Occupational Health
Obstetrics and Gynecology
medicine.disease
trachoma
Psychiatry and Mental health
Regimen
Infectious Diseases
Pediatrics, Perinatology and Child Health
Public aspects of medicine
RA1-1270
Geriatrics and Gerontology
business
co-administration
medicine.drug
Research Paper
Subjects
Details
- Language :
- English
- ISSN :
- 26666065
- Database :
- OpenAIRE
- Journal :
- Lancet Reg Health West Pac, The Lancet Regional Health. Western Pacific, Vol 18, Iss, Pp 100293-(2022)
- Accession number :
- edsair.doi.dedup.....69d66e865a21de88e049065831f19f4b