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临床试验/NCT03676140
NCT03676140已完成3 期

A Cluster Randomised Trial of the Safety of Co-Administration of IDA (Ivermectin, Diethylcarbamazine and Albendazole) & Azithromycin for Integrated Treatment of Neglected Tropical Diseases

Lihir Medical Centre1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
20,000
试验地点
1
主要终点
Self Reported Adverse Event

研究概览

简要总结

This is a cluster randomised trial evaluating the safety of co-administering Azithromycin alongside the new IDA (Ivermectin, Diethylcarbamazine, Albendazole) combination treatment for LF.

Treatment will be provided as a single dose Mass Drug Administration (MDA) to the whole community. Communities will be randomised to receive either treatment with IDA and Azithromycin on the same day or separately.

Active monitoring for adverse events will be conducted and the frequency of adverse events compared between individuals receiving combined MDA or separate MDA.

详细描述

Recent studies have shown that single-dose combination therapy with three antifilarial drugs (Ivermectin [IVE] + DEC + ALB) called IDA is superior to current regimens used in LF elimination and may help accelerate LF elimination. WHO guidelines have changed to recommend IDA in countries endemic for LF outside sub-Saharan Africa like Papua New Guinea.

Additional benefits of IVE are its activity against scabies and Strongyloides. Treatment with IVE has shown to reduce the high prevalence of scabies in a village and in randomized control trials elsewhere in the Pacific. Of particular importance was the finding that IVE was highly effective against Strongyloides with a >95% reduction in prevalence sustained for nine months.

Increasingly, the desirability of linking LF programs with other public health initiatives also based on MDA is being appreciated. The existing programmatic infrastructure developed for LF campaign presents an attractive vehicle for a demonstration project of integration of MDAs against multiple Neglected Tropical Diseases (NTDs). The macrolide antibiotic azithromycin (AZI) has been demonstrated to be highly effective as MDA for yaws control and AZI is a highly effective and well-tolerated antibiotic treatment for trachoma that is able to clear ocular infection with a single oral dose and is well tolerated.

Currently LF/STH/Scabies/strongyloides and yaws/trachoma are treated separately. Integration of these existing MDA programs has the potential to be highly cost-effective as a population health intervention. Integration includes both the safe co-administration of medicines and operational planning, and it is currently advocated by WHO.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Able to give consent

排除标准

  • Unable to give consent.
  • Less than 5 years of age (not eligible for ivermectin)**
  • Pregnant women (azithromycin only, not eligible for albendazole and ivermectin)
  • Lactating women (Only administered azithromycin and albendazole, not eligible for ivermectin)**
  • History of allergies to the drugs being studied
  • Residents who cannot swallow tablets
  • Note that patients that are not eligible for a specific drug will receive all other treatments and will be followed up through the same procedure as the other participants drug therapy to try to track any AEs attributed to specific drug combinations

研究组 & 干预措施

Separate Administration

Active Comparator

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

干预措施: Albendazole on Day 1 (Drug)

Separate Administration

Active Comparator

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

干预措施: Ivermectin on Day 1 (Drug)

Separate Administration

Active Comparator

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

干预措施: Diethylcarbamazine on day 1 (Drug)

Separate Administration

Active Comparator

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 8'

干预措施: Azithromycin on Day 8 (Drug)

Co-Administration

Experimental

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'

干预措施: Albendazole on Day 1 (Drug)

Co-Administration

Experimental

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'

干预措施: Ivermectin on Day 1 (Drug)

Co-Administration

Experimental

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'

干预措施: Diethylcarbamazine on day 1 (Drug)

Co-Administration

Experimental

'Albendazole on day 1' 'Ivermectin on day 1' 'Diethylcarbamazine on day 1' 'Azithromycin on day 1'

干预措施: Azithromycin on Day 1 (Drug)

结局指标

主要结局

Self Reported Adverse Event

时间窗: 7 Days

The incidence of self-reported adverse events following MDA. We will collect data on the presence of common symptoms/signs prior to drug administration. All patients will be reviewed 24-48 hours after treatment and asked to report adverse events. We will calculate the proportion of newly occurring adverse events following treatment and calculate the whether the proportion of patients experiencing an adverse event differs between study arms.

次要结局

未报告次要终点

研究者

发起方
Lihir Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oriol Mitja

Principal Investigator

Lihir Medical Centre

研究点 (1)

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