TrichuriasisPhase 2/3NCT04700423

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

A Phase 2/3 study testing moxidectin (8 mg) / albendazole (400 mg), ivermectin (200 µg/kg) / albendazole (400 mg) and ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL] in people with Trichuriasis and Ascariasis, run by Jennifer Keiser at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 12 to 19 years
Conditions the study is for: Trichuriasis, Ascariasis, Hookworm Infections
What is being tested?: moxidectin (8 mg) / albendazole (400 mg), ivermectin (200 µg/kg) / albendazole (400 mg) and ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 536 participants
Where: 1 siteTanzania
Study dates: 1 Mar 2021to 22 Sep 2021
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Aged between 12 and 19 years.
Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 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 on three follow-up assessments (14-21 days, 5-6 weeks and 3 months 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.

Who cannot join

No written informed consent by individual or caregiver and/or no written assent by minors
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.
History of acute or severe chronic disease.
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 6 months.
Known allergy to study medications (i.e. albendazole, ivermectin or moxidectin).
Taking medication with known interaction on study drugs.

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Public Health Laboratory Ivo de Carneri
Chake Chake, Pemba

Other trials in Tanzania

About this study

Official title: Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial

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).

Read the detailed description

We designed a non-inferiority trial to show that co-administered moxidectin and albendazole is non-inferior compared to co-administered ivermectin and albendazole in adolescents aged 12-19 years on Pemba Island (Tanzania). From previous studies conducted by our group, we expect similar efficacies from the combination moxidectin/ albendazole compared to ivermectin/ albendazole. However, moxidectin might be advantageous in terms of the drug's longer half-life and in areas with possible emerging ivermectin resistance. This study will allow comparing the efficacy of the two available co-administrations and will provide further insights on the potential value of moxidectin/ albendazole. Our data will pave the way for possible large scale, multi country follow-up studies. As recommended for new combination therapies, we simultaneously assess superiority of the drug combinations compared to monotherapies.

The primary objective is to demonstrate that co-administered moxidectin (8 mg) / albendazole (400 mg) is non-inferior to ivermectin (200 µg/kg) / albendazole (400 mg) in terms of egg reduction rates (ERRs) against T. trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in adolescents aged 12-19 years using a non-inferiority margin of 2 percentage-points.

The secondary objectives of the trial are:

Efficacy assessments of combination therapies require demonstration of superiority against the respective monotherapies. Therefore, the trial has five different treatment groups: moxidectin (8 mg) / albendazole (400 mg) combination, ivermectin (200 µg/kg) / albendazole (400 mg) combination, albendazole (400 mg) monotherapy, ivermectin (200 µg/kg) monotherapy and moxidectin (8 mg) monotherapy.
to determine the CRs of the drug regimens against T. trichiura
to evaluate the safety and tolerability of the treatment
to determine the CRs and ERRs of the treatment schemes in study participants infected with hookworm and A. lumbricoides
to investigate potential extended effects on follow-up helminth prevalences (5-6 weeks and 3 months post-treatment) of the treatment regimens
to assess diagnostic performance and compare CRs based on egg counts retrieved from novel diagnostic tools (FECPAK-G2 and/or PCR) compared to standard microscopy
to characterize population PK parameters, as well as drug-drug interactions of active study treatments following single and co-administration in T. trichiura infected adolescents. If a dose-response is observed, a PK/PD analysis will further be performed

The study will be carried out in adolescents aged 12-19 years attending secondary schools on Pemba Island, Tanzania. After consenting, all participants will be asked to provide two stool samples (within a maximum of 7 days) at each time-point assesment. From each stool specimen, duplicate Kato-Katz thick smears (41.7 mg each) will be prepared and read under a microscope for eggs of T. trichiura, A. lumbricoides and hookworm by experienced technicians.

After randomization, all eligible adolescents will be treated with the respective single or combination treatment regimen according to their assigned treatment arm at day 0.

All drugs will be administered in the presence of the PI and/ co-PI, and ingestion confirmed. This will be recorded with the time and date of dosing. Participants will be kept for 3 hours after treatment administration to observe any possible acute AEs and reassessment will be done at 24h post-treatment. Additionally, interviews will be conducted to determine the emergence of clinical symptoms such as headache, abdominal pain, itching, nausea, vomiting and diarrhea directly before treatment within the scope of baseline assessment. At 3 and 24 hours after treatment and retrospectively at days 14 - 21 as well as 5-6 weeks and 3 months post-treatment, participants will again be interviewed for the assessment of adverse events (AEs).

Egg reduction rate calculated from the geometric means of co-administered moxidectin/ albendazole and ivermectin/ albendazole against T. trichiura assessed at 14-21 days post-treatment is the primary endpoint in our study.

Conditions: Trichuriasis, Ascariasis, Hookworm Infections, Helminthes; Infestation, Intestinal
Being tested: moxidectin (8 mg) / albendazole (400 mg), ivermectin (200 µg/kg) / albendazole (400 mg), ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL], ivermectin (200 µg/kg), moxidectin (8 mg)
Keywords: T. trichiura, A. lumbricoides, Hookworm, Soil-transmitted Helminths, Albendazole, Ivermectin, Moxidectin, Intestinal parasites, Anthelmintics
Medical subject headings: Trichuriasis, Ascariasis, Hookworm Infections, Helminthiasis, Ancylostomiasis, Intestinal Diseases, Parasitic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

moxidectin (8 mg) / albendazole (400 mg)Drug
Also called Zentel®
Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg) / albendazole (400 mg)Drug
Also called Stromectol® / Zentel®
Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]Drug
Also called Zentel®
Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
ivermectin (200 µg/kg)Drug
Also called Stromectol®
Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
moxidectin (8 mg)Drug
Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0

Study groups in NCT04700423
Study group	Role	What they receive
A: moxidectin (8 mg) / albendazole (400 mg)	Experimental	Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 Receives: Drug: moxidectin (8 mg) / albendazole (400 mg)
B: ivermectin (200 µg/kg) / albendazole (400 mg)	Active comparator	Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0 Receives: Drug: ivermectin (200 µg/kg) / albendazole (400 mg)
C: albendazole (400 mg)	Active comparator	Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel® Receives: Drug: ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]
D: ivermectin (200 µg/kg)	Active comparator	Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol® Receives: Drug: ivermectin (200 µg/kg)
E: moxidectin (8 mg)	Active comparator	Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0 Receives: Drug: moxidectin (8 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Egg Reduction Rate Against T. Trichiura
Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.
Measured: 14-21 day post-treatment

Secondary outcomes (19)

Number of Participants With Adverse Events
The observation time for AE starts when the treatment is initiated. Subjects will be kept for observation for at least 3 hours following treatment for any acute AE and. If there is any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. Participants will also be interviewed at 3h and 24h as well as retrospectively 14 -21 days, 5-6 weeks and 3 months after treatment about the occurrence of AEs.
Measured: 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment
Superiority in Terms of Cure Rates (CRs)
Assessment of superiority in terms of CRs of the drug combinations compared to their corresponding monotherapies: Arm C: Albendazole (400 mg) Arm D: Ivermectin (200 μg/kg) and Arm E: Moxidectin (8 mg). Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with T. trichiura.
Measured: 14-21 day post-treatment
Cure Rates Against T. Trichiura
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 14-21 day post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 3 months post-treatment
Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 3 months post-treatment
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 14-21 days post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 3 months post-treatment
Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 3 months post-treatment
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 14-21 days post-treatment
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Cure rates is defined as the percentages of participants treated with Moxidectin (8 mg)/Albendazole (400 mg), Ivermectin (200 μg/kg)/Albendazole (400 mg), Albendazole (400 mg), Ivermectin (200 μg/kg) or Moxidectin (8 mg) who were cured of infections with A. lumbricoides.
Measured: 14-21 days post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months
Eggs per gram of stool will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs.
Measured: 3 months post-treatment
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months
Cure rates of each treatment will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: 3 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202122 Sep 2021

First posted7 Jan 2021
Study start1 Mar 2021
Primary completion18 Aug 2021
Study completion22 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TrichuriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 536 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04700423
Sponsor's protocol ID: Moxi-ALB_IVM-ALB_combi-trial
Status last verified: Nov 2024
First submitted: 6 Jan 2021
Last updated: 5 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Welsche S, Mrimi EC, Hattendorf J, Hurlimann E, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial. Lancet Infect Dis. 2023 Mar;23(3):331-340. doi: 10.1016/S1473-3099(22)00589-8. Epub 2022 Oct 28.
PubMed 36354034
Welsche S, Mrimi EC, Keller L, Hurlimann E, Hofmann D, Hattendorf J, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol. Gates Open Res. 2021 Sep 27;5:106. doi: 10.12688/gatesopenres.13299.2. eCollection 2021.
PubMed 34632308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita
Trichuris Infection
Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
RecruitingPhase 2
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Trichuriasis
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
RecruitingPhase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Whipworm, Trichuriasis

All Trichuriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Moxidectin and Albendazole Compared to Ivermectin and Albendazole Co-administration in Adolescents Infected With Trichuris Trichiura: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT04700423
Acronym / sponsor ID: Moxi-ALB_IVM-ALB_combi-trial
Conditions: Trichuriasis, Ascariasis, Hookworm Infections, Helminthes; Infestation, Intestinal
Keywords: T. trichiura, A. lumbricoides, Hookworm, Soil-transmitted Helminths, Albendazole, Ivermectin, Moxidectin, Intestinal parasites
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 536 participants (actual)
Lead sponsor: Jennifer KeiserUniversity, hospital or other
Collaborators: Public Health Laboratory Ivo de Carneri
Study start: 1 Mar 2021 (actual)
Primary completion: 18 Aug 2021 (actual)
Study completion: 22 Sep 2021 (actual)
First posted: 7 Jan 2021 (actual)
Results: Posted 5 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This trial will be conducted as a school-based study on Pemba Island (Zanzibar, Tanzania).

Detailed description

The secondary objectives of the trial are:

Efficacy assessments of combination therapies require demonstration of superiority against the respective monotherapies. Therefore, the trial has five different treatment groups: moxidectin (8 mg) / albendazole (400 mg) combination, ivermectin (200 µg/kg) / albendazole (400 mg) combination, albendazole (400 mg) monotherapy, ivermectin (200 µg/kg) monotherapy and moxidectin (8 mg) monotherapy.
to determine the CRs of the drug regimens against T. trichiura
to evaluate the safety and tolerability of the treatment
to determine the CRs and ERRs of the treatment schemes in study participants infected with hookworm and A. lumbricoides
to investigate potential extended effects on follow-up helminth prevalences (5-6 weeks and 3 months post-treatment) of the treatment regimens
to assess diagnostic performance and compare CRs based on egg counts retrieved from novel diagnostic tools (FECPAK-G2 and/or PCR) compared to standard microscopy
to characterize population PK parameters, as well as drug-drug interactions of active study treatments following single and co-administration in T. trichiura infected adolescents. If a dose-response is observed, a PK/PD analysis will further be performed

After randomization, all eligible adolescents will be treated with the respective single or combination treatment regimen according to their assigned treatment arm at day 0.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
A: moxidectin (8 mg) / albendazole (400 mg)	Experimental	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
B: ivermectin (200 µg/kg) / albendazole (400 mg)	Active comparator	Drug: ivermectin (200 µg/kg) / albendazole (400 mg)Combination therapy of ivermectin (Stromectol®, 200 µg/kg using 3 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
C: albendazole (400 mg)	Active comparator	Drug: ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]Monotherapy of albendazole (400 mg) administered orally at day 0 Other names: Zentel®
D: ivermectin (200 µg/kg)	Active comparator	Drug: ivermectin (200 µg/kg)Monotherapy of ivermectin ( 200 µg/kg using 3 mg tablets) administered orally at day 0 Other names: Stromectol®
E: moxidectin (8 mg)	Active comparator	Drug: moxidectin (8 mg)Monotherapy of moxidectin (8 mg using 2 mg tablets) administered orally at day 0

Who may qualify

Ages: 12 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Aged between 12 and 19 years.
Written informed consent signed by either parents/caregivers for underage adolescents (aged 12-17 years) or by the participant him/herself (18-19 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 on three follow-up assessments (14-21 days, 5-6 weeks and 3 months 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.

Key exclusion criteria (8 listed)

No written informed consent by individual or caregiver and/or no written assent by minors
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.
History of acute or severe chronic disease.
Recent use of anthelmintic drug (within past 4 weeks).
Attending other clinical trials during the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
moxidectin (8 mg) / albendazole (400 mg)Also: Zentel®Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0	Drug	A: moxidectin (8 mg) / albendazole (400 mg)
ivermectin (200 µg/kg) / albendazole (400 mg)Also: Stromectol® / Zentel®Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0	Drug	B: ivermectin (200 µg/kg) / albendazole (400 mg)
ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]Also: Zentel®Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0	Drug	C: albendazole (400 mg)
ivermectin (200 µg/kg)Also: Stromectol®Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0	Drug	D: ivermectin (200 µg/kg)
moxidectin (8 mg)Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0	Drug	E: moxidectin (8 mg)

Primary outcome

Egg Reduction Rate Against T. Trichiura
Time frame: 14-21 day post-treatment
Egg reduction rate is calculated as the relative reduction in the group geometric mean egg output after co-administration of moxidectin/ albendazole and ivermectin/ albendazole assessed at 14-21 days post-treatment compared to the baseline levels.

19 secondary outcomes

Number of Participants With Adverse Events
Time frame: 3 hours, 24 hours, 14-21 days, 5-6 weeks and 3 months post-treatment
Superiority in Terms of Cure Rates (CRs)
Time frame: 14-21 day post-treatment
Cure Rates Against T. Trichiura
Time frame: 14-21 day post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of T. Trichiura: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of T. Trichiura: 3 Months
Time frame: 3 months post-treatment
Extended Effects (Cure Rates) on Follow-up of T. Trichiura: 3 Months
Time frame: 3 months post-treatment
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Time frame: 14-21 days post-treatment
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Hookworm
Time frame: 14-21 days post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of Hookworm: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of Hookworm: 3 Months
Time frame: 3 months post-treatment
Extended Effects (Cure Rate) on Follow-up of Hookworm: 3 Months
Time frame: 3 months post-treatment
Egg Reduction Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Time frame: 14-21 days post-treatment
Cure Rates Against Concomitant Soil-transmitted Helminth Infections: Ascaris Lumbricoides
Time frame: 14-21 days post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 5-6 Weeks
Time frame: 5-6 weeks post-treatment
Extended Effects (Egg Reduction Rate) on Follow-up of A. Lumbricoides: 3 Months
Time frame: 3 months post-treatment
Extended Effects (Cure Rate) on Follow-up of A. Lumbricoides: 3 Months
Time frame: 3 months post-treatment

Results and safety

Results posted to the registry on 5 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A: Moxidectin (8 mg) / Albendazole (400 mg)	207	207
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)	211	211
C: Albendazole (400 mg)	19	19
D: Ivermectin (200 µg/kg)	19	19
E: Moxidectin (8 mg)	80	80

Primary outcome: Egg Reduction Rate Against T. Trichiura

Time frame: 14-21 day post-treatment. Geometric mean (95% Confidence Interval). Unit: Percent change

Measure	A: Moxidectin (8 mg) / Albendazole (400 mg) n = 207	B: Ivermectin (200 µg/kg) / Albendazole (400 mg) n = 211	C: Albendazole (400 mg) n = 19	D: Ivermectin (200 µg/kg) n = 19	E: Moxidectin (8 mg) n = 80
Value	96.8 (95.8 to 97.6)	99.0 (98.7 to 99.3)	86.2 (61.8 to 95.6)	94.2 (89.3 to 97.1)	85.5 (79.7 to 89.8)

Population analysed: Geometric mean reduction in number of eggs at baseline and assessed at 14-21 days post-treatment

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed 3h and 24h post-treatment. At the three follow-up timepoints of 14-21 days, 5-6 weeks, and 3 months after treatment, adverse events were assessed retrospectively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A: Moxidectin (8 mg) / Albendazole (400 mg)	0 of 207 (0%)	73 of 207 (35.3%)	0 of 207
B: Ivermectin (200 µg/kg) / Albendazole (400 mg)	0 of 211 (0%)	93 of 211 (44.1%)	0 of 211
C: Albendazole (400 mg)	0 of 19 (0%)	4 of 19 (21.1%)	0 of 19
D: Ivermectin (200 µg/kg)	0 of 19 (0%)	6 of 19 (31.6%)	0 of 19
E: Moxidectin (8 mg)	0 of 80 (0%)	23 of 80 (28.8%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36354034Welsche S, Mrimi EC, Hattendorf J, Hurlimann E, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial. Lancet Infect Dis. 2023 Mar;23(3):331-340. doi: 10.1016/S1473-3099(22)00589-8. Epub 2022 Oct 28.
Derived from this study: PubMed 34632308Welsche S, Mrimi EC, Keller L, Hurlimann E, Hofmann D, Hattendorf J, Ali SM, Keiser J. Efficacy and safety of moxidectin and albendazole compared to ivermectin and albendazole co-administration in adolescents infected with Trichuris trichiura: a randomized controlled trial protocol. Gates Open Res. 2021 Sep 27;5:106. doi: 10.12688/gatesopenres.13299.2. eCollection 2021.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Egg Reduction Rate Against T. Trichiura (time frame: 14-21 day post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700423, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.