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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
Age
2 - 14 years
Sex
ALL
Healthy Volunteers
No
IIET
Orán, Salta Province, Argentina
Universidad Autónoma de Honduras
Tegucigalpa, Honduras
Start Date
October 9, 2019
Primary Completion Date
March 7, 2020
Completion Date
March 7, 2020
Last Updated
July 29, 2020
176
ACTUAL participants
Ivermectin
DRUG
Albendazole
DRUG
Lead Sponsor
Alejandro Krolewiecki
Collaborators
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT01658774