Efficacy and Safety of MOX/ALB Co-administration

NCT04726969 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MAC_CI_1
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated with albendazole-ivermectin. As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.

Conditions

Trichuriasis; Ascariasis; Hookworm Infections

Keywords

Albendazole; Moxidectin; Ivermectin; Anthelmintics; T. trichiura; A. lumbricoides; Hookworm; Whipworm; Soil-transmitted helminths

Outcome Measures

Primary Outcomes (1)

• Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

  The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100.

  14-21 days after treatment

Secondary Outcomes (8)

• Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

  14-21 days after treatment

• Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

  14-21 days after treatment

• Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura

  14-21 days after treatment

• Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants

  14-21 days after treatment

• Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants

  14-21 days after treatment

Other Outcomes (4)

• Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)

  0 to 24 hours after treatment

• Genetic Variants in Ivermectin/Albendazole Participants

  before treatment, i.e. at enrolment

• Gut Bacterial Communities in Stool Samples

  before treatment, i.e. at screening, and 14-21 days after treatment

Study Arms (3)

Arm A: moxidectin and albendazole

EXPERIMENTAL

Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Moxidectin 2 mg Oral Tablet; Drug: Albendazole 400 mg Oral Tablet

Arm B: albendazole

PLACEBO COMPARATOR

Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Albendazole 400 mg Oral Tablet

Arm C: ivermectin and albendazole

EXPERIMENTAL

Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Albendazole 400 mg Oral Tablet; Drug: Ivermectin 3 mg Oral Tablet

Interventions

Moxidectin 2 mg Oral Tablet DRUG

Tablets of 2 mg moxidectin

Arm A: moxidectin and albendazole

Albendazole 400 mg Oral Tablet DRUG

Tablets of 400 mg albendazole

Also known as: Zentel®

Arm A: moxidectin and albendazole; Arm B: albendazole; Arm C: ivermectin and albendazole

Ivermectin 3 mg Oral Tablet DRUG

Tablets of 3 mg ivermectin

Also known as: Stromectol®

Arm C: ivermectin and albendazole

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged between 12 and 60 years
• Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-60 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 at follow-up assessment 14-21 days 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:

• 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
• Known or suspected infection with Loa loa
• History of acute or severe chronic disease
• Abnormal liver function assessed by multiple biochemical blood-based analyses
• 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 3 months
• Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin)
• Taking medication with known contraindication to or interaction with study drugs

Sponsors & Collaborators

• Jennifer Keiser: lead
• Centre Suisse de Recherches Scientifiques en Cote d'Ivoire: collaborator

Study Sites (1)

Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)

Abidjan, Côte d’Ivoire

Location

Related Publications (1)

• Sprecher VP, Coulibaly JT, Hurlimann E, Hattendorf J, Keiser J. Efficacy and Safety of Moxidectin-Albendazole and Ivermectin-Albendazole Combination Therapy Compared to Albendazole Monotherapy in Adolescents and Adults Infected with Trichuris trichiura: A Randomized, Controlled Superiority Trial. Clin Infect Dis. 2023 Nov 11;77(9):1294-1302. doi: 10.1093/cid/ciad387.

  PMID: 37357904 DERIVED

MeSH Terms

Conditions

Trichuriasis; Ascariasis; Hookworm Infections; Ancylostomiasis

Interventions

moxidectin; Tablets; Albendazole; Ivermectin

Condition Hierarchy (Ancestors)

Enoplida Infections; Adenophorea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Ascaridida Infections; Secernentea Infections; Strongylida Infections

Intervention Hierarchy (Ancestors)

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

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

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: The parallel group trial co-administered moxidectin/albendazole versus albendazole alone will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using tablets including appearance-matched placebos, while the ivermectin/albendazole arm will be open label due to the nature of ivermectin (i.e. requiring bodyweight-dependent doses).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: June 15, 2021
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: January 24, 2024
• Results First Posted: February 2, 2023

Record last verified: 2024-01

Locations

CÔ (1)