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

Trichuris Trichiura; Infection Clinical Trial

— MOXIDOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501251
• Other study ID #: MOXI_DOSE_PEMBA
• Status: Completed
• Phase: Phase 2
• Start date: July 3, 2018
• Est. completion date: August 11, 2018

Study information

• Verified date: August 2018
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: August 11, 2018
• Est. primary completion date: August 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Male and female subjects aged 16 to 18 years, inclusive

2. Written informed consent/assent signed from parent/guardian

3. 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)

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.

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 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 moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.

6. Pregnant (urine testing) or breastfeeding women

Related Conditions & MeSH terms

• Trichuriasis
• Trichuris Trichiura; Infection

Intervention

Drug:
• Moxidectin 8mg
Participants will receive the tablet with clean water and a package of biscuits.
• Moxidectin 8 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.
• Moxidectin 16 mg
Participants will receive the tablets with clean water and a package of biscuits.
• Moxidectin 16 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.
• Moxidectin 24 mg
Participants will receive the tablets with clean water and a package of biscuits.
• Moxidectin 24 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.

Other:
• Placebo
Participants will receive the tablet with clean water and a package of biscuits.

Locations

Country	Name	City	State
Tanzania	Public Health Laboratory Ivo de Carneri, P.O. Box 122	Chake Chake	Pemba

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Public Health Laboratory Ivo de Carneri

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate against Trichuris trichiura	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).	6 weeks
Secondary	Egg Reduction Rate of the different drug regimens against Trichuris trichiura	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 weeks
Secondary	Cure rate of the different drug regimens against Ascaris lumbricoides	Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.	6 weeks
Secondary	Egg Reduction Rate of Ascaris lumbricoides	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 weeks
Secondary	Cure rate against hookworm	Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.	6 weeks
Secondary	Egg Reduction Rate of hookworm	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 weeks
Secondary	Number of adverse events at 5 time points	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.	6 weeks