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

NCT04700423 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Moxi-ALB_IVM-ALB_combi-trial
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

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).

Conditions

Trichuriasis; Ascariasis; Hookworm Infections; Helminthes; Infestation, Intestinal

Keywords

T. trichiura; A. lumbricoides; Hookworm; Soil-transmitted Helminths; Albendazole; Ivermectin; Moxidectin; Intestinal parasites; Anthelmintics

Outcome Measures

Primary Outcomes (1)

• Egg Reduction Rate Against T. Trichiura

  Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.

  14-21 day post-treatment

Secondary Outcomes (19)

• Number of Participants With Adverse Events

  3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment

• Superiority in Terms of Cure Rates (CRs)

  14-21 day post-treatment

• Cure Rates Against T. Trichiura

  14-21 day post-treatment

• Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks

  5-6 weeks post-treatment

• Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks

  5-6 weeks post-treatment

Study Arms (5)

A: moxidectin (8 mg) / albendazole (400 mg)

EXPERIMENTAL

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)

B: ivermectin (200 µg/kg) / albendazole (400 mg)

ACTIVE COMPARATOR

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)

C: albendazole (400 mg)

ACTIVE COMPARATOR

Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®

Drug: ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]

D: ivermectin (200 µg/kg)

ACTIVE COMPARATOR

Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®

Drug: ivermectin (200 µg/kg)

E: moxidectin (8 mg)

ACTIVE COMPARATOR

Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0

Drug: moxidectin (8 mg)

Interventions

moxidectin (8 mg) / albendazole (400 mg) DRUG

Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0

Also known as: Zentel®

A: moxidectin (8 mg) / albendazole (400 mg)

ivermectin (200 µg/kg) / albendazole (400 mg) DRUG

Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0

Also known as: Stromectol® / Zentel®

B: ivermectin (200 µg/kg) / albendazole (400 mg)

ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL] DRUG

Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0

Also known as: Zentel®

C: albendazole (400 mg)

ivermectin (200 µg/kg) DRUG

Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0

Also known as: Stromectol®

D: ivermectin (200 µg/kg)

moxidectin (8 mg) DRUG

Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0

E: moxidectin (8 mg)

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Keiser: lead
• Public Health Laboratory Ivo de Carneri: collaborator

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Pemba, Tanzania

Location

Related Publications (2)

• Welsche S, Mrimi EC, Hattendorf J, Hurlimann E, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial. Lancet Infect Dis. 2023 Mar;23(3):331-340. doi: 10.1016/S1473-3099(22)00589-8. Epub 2022 Oct 28.

  PMID: 36354034 DERIVED

• Welsche S, Mrimi EC, Keller L, Hurlimann E, Hofmann D, Hattendorf J, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol. Gates Open Res. 2021 Sep 27;5:106. doi: 10.12688/gatesopenres.13299.2. eCollection 2021.

  PMID: 34632308 DERIVED

MeSH Terms

Conditions

Trichuriasis; Ascariasis; Hookworm Infections; Helminthiasis; Ancylostomiasis; Intestinal Diseases, Parasitic

Interventions

moxidectin; Albendazole; Ivermectin; Tablets

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Parasitic Diseases; Infections; Ascaridida Infections; Secernentea Infections; Strongylida Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Prof. Dr. Jennifer Keiser
• Organization: Swiss TPH

jennifer.keiser@swisstph.ch

+41612848218

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open Label with masked outcomes assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: March 1, 2021
• Primary Completion: August 18, 2021
• Study Completion: September 22, 2021
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-11

Locations

TA (1)