Efficacy and Safety of Moxidectin-Albendazole Co-administration in SAC

NCT06188715 | Completed Phase 3 Results FDA Drug

• 1 other identifier: Moxiped_1
• Study Type: interventional
• Target: 224
• 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 compared to albendazole monotherapy in school-aged children (SAC; aged 6-12 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, evidence on the safety profile of moxidectin-albendazole combination in this age group will be substantiated using a placebo (and albendazole) only arm. To date, this has only been established in adolescents (aged 16-18 years), who might present different symptoms or symptom severity compared with SAC. 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

Moxidectin; Albendazole; Anthelminthics; Trichuris trichiura; Ascaris lumbricoides; Hookworm; Whipworm; Soil-transmitted helminths

Outcome Measures

Primary Outcomes (1)

• Cure Rate (CR) 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.

  14-21 days post-treatment

Secondary Outcomes (9)

• Egg Reduction Rate (ERR) Against T. Trichiura (Geometric Mean ERR)

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against T. Trichiura (Arithmetic Mean ERR)

  14-21 days post-treatment

• Cure Rate (CR) Against A. Lumbricoides

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against A. Lumbricoides (Geometric Mean ERR)

  14-21 days post-treatment

• Egg Reduction Rate (ERR) Against A. Lumbricoides (Arithmetic Mean ERR)

  14-21 days post-treatment

Other Outcomes (1)

• Blood Concentration of Moxidectin

  0 to 24 hours post-treatment

Study Arms (3)

Arm A: Moxidectin 4/8 mg & Albendazole

EXPERIMENTAL

Combination therapy of moxidectin (4 mg or 8 mg, i.e. 2 or 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

ACTIVE COMPARATOR

Placebo for moxidectin (2 or 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

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

Arm C: Placebo

PLACEBO COMPARATOR

Placebo for moxidectin (2 or 4 tablets) and placebo for albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0

Drug: Placebo Moxidectin; Drug: Placebo Albendazole

Interventions

Moxidectin 2 mg Oral Tablet DRUG

Tablets of 2 mg moxidectin

Arm A: Moxidectin 4/8 mg & Albendazole

Albendazole 400 mg Oral Tablet DRUG

Tablets of 400 mg albendazole

Also known as: Zentel®

Arm A: Moxidectin 4/8 mg & Albendazole; Arm B: Albendazole

Placebo Moxidectin DRUG

Placebo tablets for moxidectin

Arm B: Albendazole; Arm C: Placebo

Placebo Albendazole DRUG

Placebo tablets for albendazole

Arm C: Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• individuals aged 6-12 years (confirmed by birth certificate or similar document)
• having given written informed consent signed by parents/caregivers
• being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days)
• having at least two out of four Kato-Katz slides positive for T. trichiura at baseline
• being able and willing to be examined by a study physician before and after treatment

You may not qualify if:

• presence or signs of major systemic illness, e.g. fever (temporal body temperature of \>38.0°C), severe anaemia (haemoglobin level of \<80 g/l)
• history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary)
• use of anthelminthic drugs during study period
• known allergy to study medication (i.e., moxidectin or albendazole)
• being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication
• pregnancy (female participants aged 10-12 years)
• concurrent participation in other clinical trials

Sponsors & Collaborators

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

Study Sites (1)

Public Health Laboratory Ivo de Carneri

Chake Chake, Tanzania

Location

Related Publications (1)

• Schnoz A, Sprecher VP, Biendl S, Hussein HS, Najim SO, Ali MN, Mohammed IS, Ali SM, Hattendorf J, Keiser J. Efficacy and safety of moxidectin-albendazole combination therapy for Trichuris trichiura infections in school-aged children: a double-blind, randomised, controlled, superiority trial. Lancet Infect Dis. 2025 Dec;25(12):1325-1335. doi: 10.1016/S1473-3099(25)00344-5. Epub 2025 Jul 14.

  PMID: 40675166 DERIVED

MeSH Terms

Conditions

Trichuriasis; Ascariasis; Hookworm Infections; Ancylostomiasis

Interventions

moxidectin; Tablets; Albendazole

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

Results Point of Contact

• Title: Prof 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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using appearance-matching placebos.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: May 14, 2024
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: September 19, 2025
• Results First Posted: September 19, 2025

Record last verified: 2025-09

Locations

TA (1)