Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
Condition: Trichuris Infection; Helminthiasis
MeSH terms: Helminthiasis; Trichuriasis
Intervention: Ivermectin; Albendazole
Intervention description: Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.; Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.
Intervention MeSH terms: Ivermectin; Albendazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 2 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: TRICHURIS; STH; IVERMECTIN; ALBENDAZOLE

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.