Efficacy, Safety, and PK of Ascending Dosages of Moxidectin Versus Ivermectin Against Strongyloides Stercoralis

NCT04056325 | Completed Phase 2 Results

• 1 other identifier: 3
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 2, blinded and randomized clinical trial. The phase 2a trial is single blinded and conducted in Lao, while the phase 2b trial is double-blinded and conducted in Lao and Cambodia. The study aims at providing evidence on effective doses and safety of moxidectin in adults against infection with S. stercoralis in Laos (trial 2a) and efficacy and safety of moxidectin compared to ivermectin in adults against infection with S. stercoralis in Laos and Cambodia (trial 2b). The efficacy of the treatment will be assessed by collecting three stool samples once pre-treatment and once 21 days post-treatment. The stool samples will be analyzed by a quantitative Baermann assay.

Conditions

Strongyloides Stercoralis Infection

Outcome Measures

Primary Outcomes (1)

• Observed Cure Rate Against Strongyloides Stercoralis

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

  Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

Secondary Outcomes (9)

• Observed Larvae-reduction Rate (LRR) Against Strongyloides Stercoralis

  Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

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

  Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

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

  Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

• Observed CRs Against Concomitant Soil-transmitted Helminth Infections - Hookworm

  Phase 2a: 21-28 days after treatment; phase 2b: 14-21 days after treatment

• Number of Participants Reporting Adverse Events

  2-3 hours, 24 hours, and retrospectively 21-28 days (phase 2a) or 14-21 days (phase 2b Arm A and Arm B) after treatment.

Study Arms (9)

Phase 2a - Arm A

EXPERIMENTAL

2 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm B

EXPERIMENTAL

4 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm C

EXPERIMENTAL

6 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm D

EXPERIMENTAL

8 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm E

EXPERIMENTAL

10 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm F

EXPERIMENTAL

12 mg Moxidectin at day 0 administered orally

Drug: Moxidectin

Phase 2a - Arm G

PLACEBO COMPARATOR

matching Placebo tablet(s) at day 0 administered orally

Drug: Placebo oral tablet

Phase 2b - Arm A

EXPERIMENTAL

the recommended dose moxidectin (i.e. the most promising dosage identified in phase 2a; between 2-12 mg) at day 0 administered orally \+ Ivermectin placebo, corresponding to Phase 2b - Arm B

Drug: Moxidectin

Phase 2b - Arm B

ACTIVE COMPARATOR

200 µg/kg ivermectin at day 0 administered orally \+ Moxidectin placebo, corresponding to Phase 2b - Arm A

Drug: Ivermectin

Interventions

Moxidectin DRUG

Monotherapy, oral administration, single dose, fixed dose

Phase 2a - Arm A; Phase 2a - Arm B; Phase 2a - Arm C; Phase 2a - Arm D; Phase 2a - Arm E; Phase 2a - Arm F; Phase 2b - Arm A

Ivermectin DRUG

Monotherapy, oral administration, single dose, weight dependent

Phase 2b - Arm B

Placebo oral tablet DRUG

Monotherapy, oral administration, single dose, matching number of tablets

Phase 2a - Arm G

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults (≥ 18 years) infected with S. stercoralis
• Absence of major systemic illnesses
• Written informed consent signed by individual

You may not qualify if:

• Any abnormal medical conditions or chronic disease
• Negative diagnostic result for S. stercoralis
• No written informed consent by individual.
• Pregnant and lactating women.
• Recent use of 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 Institute of Public Health, Vientiane, Laos: collaborator

Study Sites (1)

National Institute of Public Health

Vientiane, Laos

Location

Related Publications (3)

• 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

• Smit C, Hofmann D, Sayasone S, Keiser J, Pfister M. Characterization of the Population Pharmacokinetics of Moxidectin in Adults Infected with Strongyloides Stercoralis: Support for a Fixed-Dose Treatment Regimen. Clin Pharmacokinet. 2022 Jan;61(1):123-132. doi: 10.1007/s40262-021-01048-4. Epub 2021 Jul 23.

  PMID: 34296417 DERIVED

• Hofmann D, Sayasone S, Sengngam K, Chongvilay B, Hattendorf J, Keiser J. Efficacy and safety of ascending doses of moxidectin against Strongyloides stercoralis infections in adults: a randomised, parallel-group, single-blinded, placebo-controlled, dose-ranging, phase 2a trial. Lancet Infect Dis. 2021 Aug;21(8):1151-1160. doi: 10.1016/S1473-3099(20)30691-5. Epub 2021 Mar 30.

  PMID: 33798487 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.

  Swiss TPH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Phase 2a: single-blinded (participant and lab technician) Phase 2b: double-blinded (participant, Care Provider) PK sub-studies are single-blinded (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Jennifer Keiser, PhD

Model Details: Phase 2a: Parallel study with 7 treatment arms (including a placebo arm) Phase 2b: Parallel study with 2 treatment arms

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 14, 2019
• Study Start: November 27, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Locations

LA (1)