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

NCT04700423 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2024-12-05

Study results available
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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

Interventions

DRUG

moxidectin (8 mg) / albendazole (400 mg)

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

DRUG

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

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

DRUG

ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]

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

DRUG

ivermectin (200 µg/kg)

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

DRUG

moxidectin (8 mg)

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

Sponsors & Collaborators

  • Public Health Laboratory Ivo de Carneri

    collaborator OTHER

  • Jennifer Keiser

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-08-18
Completion
2021-09-22
FDA Drug
Yes

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700423 on ClinicalTrials.gov