Albendazole Dose Finding and Pharmacokinetics in Children and Adults
Condition: Trichuriasis; Hookworm Infections
MeSH terms: Hookworm Infections; Ancylostomiasis; Trichuriasis
Intervention: Albendazole; Albendazole; Albendazole; Albendazole; Placebo
Intervention description: Single dose of albendazole (200mg, dependent on treatment cohort); Single dose of albendazole (400mg, dependent on treatment cohort); Single dose of albendazole (600mg, dependent on treatment cohort); Single dose of albendazole (800mg, dependent on treatment cohort); Matching placebo tablets will be obtained from Fagron, Germany.
Intervention MeSH terms: Albendazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 700.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This
      study aims at providing evidence on the dose-response of increasing oral albendazole dosages
      against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years),
      school-aged children (6-12 years) and adults (≥ 21 years).

      The primary objective is to determine cure rates (primary end point, i.e. conversion from
      being egg positive pre-treatment to egg negative post-treatment). Secondary objectives
      involve the determination of egg reduction rates (the reduction in the number of excreted
      eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of
      ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic
      parameters will be determined from blood samples collected with a micro-sampling device
      (secondary end point).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female adults (≥21 years), preschool-aged children (2-5 years) and
             school-aged children (6-12 years) infected with T. trichiura/hookworm

          2. Written informed consent/assent signed from parent/guardian

          3. Positive for T. trichiura/hookworm by at least two slides of the quadruple Kato-Katz
             thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)

          4. Agree to comply with study procedures, including provision of two stool samples at the
             beginning (baseline) and approximately three weeks after treatment (follow-up).

        Exclusion Criteria:

          1. Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection,
             clinical malaria) as assessed by a medical doctor, upon initial clinical assessment
             and liver function tests.

          2. Known or reported history of chronic illness such as HIV, acute or chronic hepatitis,
             cancer, diabetes, chronic heart disease or renal disease.

          3. Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin,
             mebendazole or albendazole) within 4 weeks before planned test article administration.

          4. Received any investigational drugs or investigational devices within 4 weeks before
             administration of test article that may confound safety and/or efficacy assessments.

          5. Known or suspected allergy to benzimidazoles.

          6. Pregnant (urine testing) or breastfeeding women