Efficacy and Safety of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

NCT04848688 | Completed Phase 3 Results

• 1 other identifier: 4
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an extension to the study StrongMoxi NCT04056325 and entails modifications based on the outcome of NCT04056325 part A. The study is a phase 3, double-blinded and randomized clinical trial conducted in Cambodia. It aims at providing evidence on efficacy, safety and pharmacokinetic measures of 8 mg of moxidectin compared to 200 μg/kg ivermectin in adults infected with S. stercoralis. The efficacy of the treatment will be assessed by collecting three stool samples once per-treatment and once 21-28 days post-treatment. The stool samples will be analyzed by a quantitative duplicate Baermann assay.

Conditions

Strongyloides Stercoralis Infection

Outcome Measures

Primary Outcomes (1)

• Cure Rate Against Strongyloides Stercoralis

  The conversion from being larvae positive pre-treatment to larvae negative post-treatment, or cure rate (CR).

  14-21 days after treatment

Secondary Outcomes (5)

• Larvae Reduction Rate (LRR) Against Strongyloidiasis Stercoralis

  14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days as well as the sample collection every second day between day 0 and day 70 (Moxidectin arm, n=50) was not performed.

• CRs Against Concomitant Soil-transmitted Helminth Infections - Ascaris Lumbricoides

  14-21 days after treatment

• CRs Against Concomitant Soil-transmitted Helminth Infections - Trichuris Trichiura

  14-21 days after treatment

• CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm

  14-21 days after treatment

• Number of Participants Reporting Adverse Events

  2-3 hours, 24 hours and 14-21 days after treatment. The originally planned follow-ups at 42-49 days and 63-70 days after treatment were not conducted.

Other Outcomes (2)

• Socioeconomic Characteristics (SES)

  Pre-treatment

• Genetic Profiling of S. Stercoralis Positive Stool Samples

  Pre-treatment

Study Arms (2)

Moxidectin

EXPERIMENTAL

8 mg Moxidectin at day 0 administered orally

Drug: Moxidectin 2 mg; Drug: Placebo

Ivermectin

EXPERIMENTAL

200 ug/kg Ivermectin at day 0 administered orally

Drug: Ivermectin 3 mg; Drug: Placebo

Interventions

Moxidectin 2 mg DRUG

Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets of 2 mg each to yield an 8 mg final dose.

Moxidectin

Ivermectin 3 mg DRUG

Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.

Ivermectin

Placebo DRUG

Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin

Ivermectin; Moxidectin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18-65 years)
• Infected with S. stercoralis (positive)
• Absence of major systemic illnesses
• Written informed consent

You may not qualify if:

• Any abnormal medical conditions or chronic disease
• Negative diagnostic result for S. stercoralis
• No written informed consent by the individual.
• Pregnant and lactating women.
• Recent use of an anthelmintic drug (within past 4 weeks)
• Attending other clinical trials during the study
• Known allergy to study medications (i.e. moxidectin, ivermectin)
• Currently taking medications with known interaction (i.e. for warfarin)

Sponsors & Collaborators

• Jennifer Keiser: lead
• National Centre for Parasitology, Entomology and Malaria Control, Cambodia: collaborator

Study Sites (1)

National Centre for Parasitology, Entomology and Malaria Control

Phnom Penh, Cambodia

Location

Related Publications (1)

• Sprecher VP, Hofmann D, Savathdy V, Xayavong P, Norkhankhame C, Huy R, Khieu V, Sayasone S, Hattendorf J, Keiser J. Efficacy and safety of moxidectin compared with ivermectin against Strongyloides stercoralis infection in adults in Laos and Cambodia: a randomised, double-blind, non-inferiority, phase 2b/3 trial. Lancet Infect Dis. 2024 Feb;24(2):196-205. doi: 10.1016/S1473-3099(23)00507-8. Epub 2023 Nov 7.

  PMID: 37949090 DERIVED

MeSH Terms

Interventions

moxidectin; Ivermectin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Prof Dr Jennifer Keiser
• Organization: Swiss Tropical and Public Health Institute

jennifer.keiser@swisstph.ch

+41 61 284 82 18

Study Officials

• Jennifer Keiser, Prof. Dr

  STPH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded (Participant and Care provider) Additionally, the principal investigator and the statistician will be blinded. PK substudy is single-blinded (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Jennifer Keiser, PhD

Model Details: Parallel study with 2 treatment arms

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: February 5, 2022
• Primary Completion: July 17, 2022
• Study Completion: July 17, 2022
• Last Updated: January 25, 2024
• Results First Posted: January 24, 2024

Record last verified: 2024-01

Locations

CA (1)