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Completed

NCT Number: NCT03501251

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura

The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.

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Key information

Conditions

Trichuris Trichiura; Infection Adenophorea Infections Enoplida Infections Helminthiasis Infections Nematode Infections Parasitic Diseases Trichuriasis

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Public Health Laboratory Ivo de Carneri, P.O. Box 122

Chake Chake, Pemba, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects aged 16 to 18 years, inclusive
  • Written informed consent/assent signed from parent/guardian
  • Positive for T. trichiura 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)
  • 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

  • Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
  • Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
  • Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
  • Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
  • Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
  • Pregnant (urine testing) or breastfeeding women

Treatment and study plan

Moxidectin 8mg

Drug

Participants will receive the tablet with clean water and a package of biscuits.

Moxidectin 8 mg + albendazole 400 mg

Drug

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 16 mg

Drug

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 16 mg + albendazole 400 mg

Drug

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 24 mg

Drug

Participants will receive the tablets with clean water and a package of biscuits.

Moxidectin 24 mg + albendazole 400 mg

Drug

Participants will receive the tablets with clean water and a package of biscuits.

Placebo

Other

Participants will receive the tablet with clean water and a package of biscuits.

Primary outcomes

  1. Cure rate against Trichuris trichiura

    Time frame: 6 weeks

    Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).

Secondary outcomes

  1. Egg Reduction Rate of the different drug regimens against Trichuris trichiura

    Time frame: 6 weeks

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.

  2. Cure rate of the different drug regimens against Ascaris lumbricoides

    Time frame: 6 weeks

    Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.

  3. Egg Reduction Rate of Ascaris lumbricoides

    Time frame: 6 weeks

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.

  4. Cure rate against hookworm

    Time frame: 6 weeks

    Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.

  5. Egg Reduction Rate of hookworm

    Time frame: 6 weeks

    Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.

  6. Number of adverse events at 5 time points

    Time frame: 6 weeks

    Patients will be kept for observation for at least 3 hours following treatment for any acute adverse events. During the reporting period, any unfavorable changes in the subject's condition will be recorded as adverse events, whether reported by the subject or observed by the Investigator. In case of any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition, patients will be also interviewed by a nurse and/or a physician about the occurrence of adverse events 24, 48 and 72 hours post-treatment using a questionnaire. Finally, upon collection of the first follow-up stool sample participants will be re-questioned.

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Public Health Laboratory Ivo de Carneri

Registry information

Official study title

Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial

Acronym: MOXIDOSE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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