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Efficacy and Safety of MOX/ALB vs. IVM/ALB Co-administration

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700423
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Public Health Laboratory Ivo de Carneri, Chake Chake, Pemba, Zanzibar, Tanzania
Information provided by (Responsible Party):
Jennifer Keiser, Swiss Tropical & Public Health Institute

Brief Summary:

The aim of this randomized controlled trial is to provide evidence on the efficacy and safety of co-administered moxidectin and albendazole compared to co-administered ivermectin and albendazole, and to assess the efficacy of the drug combinations compared to monotherapies in adolescents aged 12-19 years against infection with T. trichiura.

The efficacy of the different treatments will be determined 14-21 days, 5-6 weeks and 3 months post-treatment. Two fecal samples will be collected at each time-point assessment. The geometric mean based egg reduction rate (ERR) of T. trichiura egg counts will be assessed by Kato-Katz microscopy pre-treatment and 14-21 days post-treatment.

This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).


Condition or disease Intervention/treatment Phase
Trichuriasis Ascariasis Hookworm Infections Helminthes; Infestation, Intestinal Drug: moxidectin (8 mg) / albendazole (400 mg) Drug: ivermectin (200 µg/kg) / albendazole (400 mg) Drug: ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL] Drug: ivermectin (200 µg/kg) Drug: moxidectin (8 mg) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Open Label with masked outcomes assessors
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: A: moxidectin (8 mg) / albendazole (400 mg)
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Drug: moxidectin (8 mg) / albendazole (400 mg)
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Other Name: Zentel®

Active Comparator: B: ivermectin (200 µg/kg) / albendazole (400 mg)
Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Drug: ivermectin (200 µg/kg) / albendazole (400 mg)
Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Other Name: Stromectol® / Zentel®

Active Comparator: C: albendazole (400 mg)
Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
Drug: ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]
Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
Other Name: Zentel®

Active Comparator: D: ivermectin (200 µg/kg)
Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
Drug: ivermectin (200 µg/kg)
Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
Other Name: Stromectol®

Active Comparator: E: moxidectin (8 mg)
Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0
Drug: moxidectin (8 mg)
Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0




Primary Outcome Measures :
  1. Egg reduction rate against T. trichiura [ Time Frame: 14-21 day post-treatment ]
    Egg reduction rate calculated from the geometric means of co-administered moxidectin/ albendazole and ivermectin/ albendazole against T. trichiura assessed at 14-21 days post-treatment is the primary endpoint in our study.


Secondary Outcome Measures :
  1. Superiority in terms of cure rates (CRs) [ Time Frame: 14-21 day post-treatment ]
    Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg)

  2. CRs against T. trichiura [ Time Frame: 14-21 day post-treatment ]
    CRs of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

  3. Safety and tolerability [ Time Frame: treatment until 3 months post-treatment ]
    The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is 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. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs.

  4. Cure rates and egg reduction rates against concomitant soil-transmitted helminth infections [ Time Frame: 14-21 days post-treatment ]

    CRs and ERR will be calculated for Ascaris lumbricoides and hookworm infections.

    CRs of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.

    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.


  5. Extended effects on follow-up helminth prevalence [ Time Frame: 5-6 weeks and 3 months post-treatment ]
    CRs and ERR will be calculated for T. trichiura, A. lumbricoides and hookworm infections.

  6. Diagnostic performance [ Time Frame: baseline and 14-21 days post-treatment ]
    Comparison of CRs based on egg counts retrieved from novel diagnostic tools (FECPAK-G2 and/or PCR) compared to standard microscopy (Kato-Katz method)

  7. Pharmacokinetics and drug-drug interactions [ Time Frame: between 0 and 72 hours ]
    Characterization of population PK parameters, as well as drug-drug interactions of active study treatments following single and co-administration in T. trichiura infected adolescents. If a dose-response is observed, a PK/PD analysis will further be performed



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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 12 and 19 years.
  • Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 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 on three follow-up assessments (14-21 days, 5-6 weeks and 3 months 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:

  • No written informed consent by individual or caregiver and/or no written assent by minors
  • 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.
  • History of acute or severe chronic disease.
  • 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 6 months.
  • Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin).
  • Taking medication with known interaction on study drugs.

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): NCT04700423


Contacts
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Contact: Jennifer Keiser, Prof + 41 61 284 8218 jennifer.keiser@swisstph.ch
Contact: Said Mohammed Ali +255 24 24 52003 said@phlidc.org

Sponsors and Collaborators
Jennifer Keiser
Public Health Laboratory Ivo de Carneri, Chake Chake, Pemba, Zanzibar, Tanzania
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Responsible Party: Jennifer Keiser, Prof. Dr., Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT04700423    
Other Study ID Numbers: Moxi-ALB_IVM-ALB_combi-trial
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Jennifer Keiser, Swiss Tropical & Public Health Institute:
T. trichiura
A. lumbricoides
Hookworm
Soil-transmitted Helminths
Albendazole
Ivermectin
Moxidectin
Intestinal parasites
Anthelmintics
Additional relevant MeSH terms:
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Hookworm Infections
Ancylostomiasis
Trichuriasis
Ascariasis
Helminthiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Parasitic Diseases
Enoplida Infections
Adenophorea Infections
Ascaridida Infections
Ivermectin
Albendazole
Milbemycin
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antinematodal Agents