Efficacy and Safety of MOX/ALB Co-administration
Condition: Trichuriasis; Ascariasis; Hookworm Infections
MeSH terms: Hookworm Infections; Ancylostomiasis; Trichuriasis; Ascariasis
Intervention: Moxidectin 2 mg Oral Tablet; Albendazole 400 mg Oral Tablet; Ivermectin 3 mg Oral Tablet
Intervention description: Tablets of 2 mg moxidectin; Tablets of 400 mg albendazole; Tablets of 3 mg ivermectin
Intervention MeSH terms: Ivermectin; Albendazole; Moxidectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The parallel group trial co-administered moxidectin/albendazole versus albendazole alone will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using tablets including appearance-matched placebos, while the ivermectin/albendazole arm will be open label due to the nature of ivermectin (i.e. requiring bodyweight-dependent doses).
Enrollment: 255.0
Sex: All
Minimum age: 12 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Albendazole; Moxidectin; Ivermectin; Anthelmintics; T. trichiura; A. lumbricoides; Hookworm; Whipworm; Soil-transmitted helminths

Summary:

      This study is a double-blind randomized controlled superiority trial aiming at providing
      evidence on the efficacy and safety of co-administered moxidectin and albendazole versus
      albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in
      adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated
      with albendazole-ivermectin.

      As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at
      baseline who become egg-negative after treatment) will be determined 14-21 days
      post-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged between 12 and 60 years

          -  Written informed consent signed by either parents/caregivers for underage adolescents
             (aged 12-17 years) or by the participant him/herself (18-60 years of age); and written
             assent by underage participant

          -  Agree to comply with study procedures, including provision of two stool samples at the
             beginning (baseline) and at follow-up assessment 14-21 days after treatment

          -  Willing to be examined by a study physician prior to treatment

          -  At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura
             and infection intensities of at least 48 EPG

        Exclusion Criteria:

          -  Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, severe
             anemia (below 80g/l Hb according to WHO) upon initial clinical assessment

          -  Known or suspected infection with Loa loa

          -  History of acute or severe chronic disease

          -  Abnormal liver function assessed by multiple biochemical blood-based analyses

          -  Recent use of anthelmintic drug (within past 4 weeks)

          -  Attending other clinical trials during the study

          -  Pregnancy, lactating, and/or planning to become pregnant within the next 3 months

          -  Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin)

          -  Taking medication with known contraindication to or interaction with study drugs