跳至主要内容
临床试验/NCT00659997
NCT00659997已完成4 期

Longitudinal Study of Efficacy of Standard Albendazole Treatment Versus Levamisole/Pyrantel Pamoate on Soil Transmitted Helminth Infections

Natural History Museum, United Kingdom1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Clearance of STH faecal eggs in patient stool

研究概览

简要总结

Field epidemiological studies undertaken during 2005 in four village locations in Northern Unguja, Zanzibar examined mothers and their pre-school aged children for helminth infections.

The prevalence of Ascaris lumbricoides was found to have remained relatively high despite community-wide treatment with the mass administration of Albendazole (a WHO recommended de-wormer) in coordination with community vitamin A supplementation.

One hypothesis for this is that the children and mothers had Ascaris infections more tolerant to Albendazole that subsequently failed to clear. It is necessary to compare the present drug efficiency of Albendazole (first-line de-wormer) with Levamisole (second-line de-wormer) on STH infections such patients a case-control setting to shed light on the putative resistance of local Ascaris/Trichuris to albendazole.

In so doing, this should clarify whether there is resistance developing towards Albendazole and have possible implications for introducing combination therapies of Levamisole and Albendazole for first line de-worming mothers and their children in the future.

详细描述

The study was conducted in 10 villages on Unguja Island representative of urban, semi-urban and rural environments. After liaison with the local Shehia (the elected community leader) mothers and their children aged between 6 months and 5 years old were invited to attend a walk-in mobile clinic. In accordance with WHO sample size recommendations of 30 individuals per site and to cater for drop-out/non-compliance, target enrolment was about 50 mother and child pairs at each study village.

Stool specimens were transported to the Helmtin Control Laboratory Unguja laboratory for visual inspection of stool consistency and presence of blood, after which a single Kato-Katz thick smear (41.7mg) was prepared. Eggs of all STH species were counted by inspection at 100x microscopy and expressed as a tally of eggs per gram (EPG). To ensure consistency of egg counts, slides were read by the same two technicians for each study village.

10 Mother and child pairs found positive for Ascaris and/or Trichuris were randomised, by coin tossing, to receive either a single tablet of ALB (400mg) or an appropriate dose of LEV (2.5 mg/kg). A parasitological follow-up took place 18 days after treatment where a requested stool sample was analyzed by a single Kato-Katz thick smear for assessment of STH clearance. In accordance with WHO's 'no survey without service' all attendees were given an additional ALB tablet.

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
Single (Participant)

入排标准

年龄范围
1 Year 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Presently with soil-transmitted helminthiasis

排除标准

  • absence of soil-transmitted helminthiasis

研究组 & 干预措施

1

Active Comparator

1 Individuals treated with Albendazole

干预措施: Albendazole (Drug)

2

Active Comparator

Individuals treated with Levamisole

干预措施: Levamisole (Drug)

结局指标

主要结局

Clearance of STH faecal eggs in patient stool

时间窗: 18 days

次要结局

未报告次要终点

研究者

发起方
Natural History Museum, United Kingdom
申办方类型
Other Gov

研究点 (1)

Loading locations...

相似试验

Efficacy Albendazole and Levamisole Against STH on... | 临床试验