Helminthiasis Clinical Trial
Official title:
Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
There are four species of intestinal worms collectively known as soil-transmitted
helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris
lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over
two billion people and contribute to significant morbidity and disability, especially in high
risk groups, for example children, agricultural workers and pregnant women. In children, STH
are associated with impaired nutritional status evidenced by stunting, thinness and
underweight.
As is the case in most Latin America, STH are a public health problem in Honduras. The World
Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age)
in the country are at risk of infection. To control these infections Honduras has established
a national deworming program that operates since 2001 but despite these efforts, the
prevalence of STH infections remains unacceptably high. This is especially true in rural
communities where prevalence can be as high as 70% of the children population.
Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to
improve efficacy compared to any of these drugs in monotherapy; the efficacy is however,
still inadequate in terms of cure rate, although egg reduction rates are significant.
The purpose of the current trial is to assess the safety and efficacy of 3 experimental
regimens for the treatment of infections by Trichuris trichiura in children in comparison
with the current standard of practice in Mass Drug Administration (MDA) campaigns. The
experimental regimens will explore the effect of multiple day regimens and high dose
ivermectin.
Treatment arms:
- Group 1: single dose of ALB 400 mg. (active control arm). N:39
- Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57
- Group 3: daily dose ALB 400mg for 3 consecutive days. N:24
- Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57
Total Study Population: 177
n/a
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