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Phase 2 N=176 Randomized Single-blind Treatment

Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients

Trichuris Infection · Helminthiasis

Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Cure Rate — 1; 31; 6; 40 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ivermectin (Drug); Albendazole (Drug)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Alejandro Krolewiecki
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Cure Rate
1; 31; 6; 40
SECONDARY
Egg Change Rate
50; 97; 72; 100
SECONDARY
Beta Tubulin Resistance

Summary

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

Eligibility Criteria

Inclusion Criteria

  • Infection with T. trichiura by Kato Katz.
  • Body weight >15kg.
  • Accepts participation

Exclusion Criteria

  • Albendazole and/or mebendazol treatment in the previous 3 months.
  • Allergy to the study drugs
  • Acute medical conditions
  • Clinical trial participation in the previous 3 months.
  • Pregnancy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04041453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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