Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501251
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Public Health Laboratory Ivo de Carneri
Information provided by (Responsible Party):
Jennifer Keiser, Swiss Tropical & Public Health Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Trichuris Trichiura; Infection Drug: Moxidectin 8mg Drug: Moxidectin 8 mg + albendazole 400 mg Drug: Moxidectin 16 mg Drug: Moxidectin 16 mg + albendazole 400 mg Drug: Moxidectin 24 mg Drug: Moxidectin 24 mg + albendazole 400 mg Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 286 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants will receive placebos. Outcome assessors and caregivers will not have access to the list of children allocated to each treatment arm.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial
Actual Study Start Date : July 3, 2018
Actual Primary Completion Date : August 11, 2018
Actual Study Completion Date : August 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Moxidectin 8 mg
A single tablet of 8 mg of moxidectin
Drug: Moxidectin 8mg
Participants will receive the tablet with clean water and a package of biscuits.

Experimental: Moxidectin 8 mg + Albendazole
A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 8 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.

Experimental: Moxidectin 16 mg
Two tablets of 8 mg of moxidectin ( = 16 mg)
Drug: Moxidectin 16 mg
Participants will receive the tablets with clean water and a package of biscuits.

Experimental: Moxidectin 16 mg + Albendazole
Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 16 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.

Experimental: Moxidectin 24 mg
Three tablets of 8 mg of moxidectin ( = 24 mg)
Drug: Moxidectin 24 mg
Participants will receive the tablets with clean water and a package of biscuits.

Experimental: Moxidectin 24 mg + Albendazole
Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg)
Drug: Moxidectin 24 mg + albendazole 400 mg
Participants will receive the tablets with clean water and a package of biscuits.

Placebo Comparator: Placebo
A single tablet of placebo
Other: Placebo
Participants will receive the tablet with clean water and a package of biscuits.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501251


Locations
Layout table for location information
Tanzania
Public Health Laboratory Ivo de Carneri, P.O. Box 122
Chake Chake, Pemba, Tanzania
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Public Health Laboratory Ivo de Carneri

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jennifer Keiser, Principal Investigator, Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT03501251     History of Changes
Other Study ID Numbers: MOXI_DOSE_PEMBA
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Trichuriasis
Enoplida Infections
Adenophorea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Milbemycin
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents