TrichuriasisPhase 3FACEITefficNCT06037876
Efficacy of Ivermectin-albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura
A Phase 3 study testing IVM (200 µg/kg) + ALB (400 mg) and ALB (400mg) in people with Trichuriasis, run by Jennifer Keiser at 1 site in Uganda.
Trial summary
The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Trichuriasis
- What is being tested?
- IVM (200 µg/kg) + ALB (400 mg) and ALB (400mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUganda
- Study dates
- 9 Oct 2023to 14 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent for participation signed from caregivers; and written assent by participants.
- 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 nurse/physician prior to treatment.
- At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.
Who cannot join
- Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.
- Recent use of anthelmintic drug (within past 4 weeks).
- Attending other experimental research studies.
- Known allergy to study medications (i.e. benzimidazole or ivermectin).
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health
Kampala, P.O.Box 1661
About this study
Official title: Efficacy of the Combination Ivermectin and Albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura: a Randomized Controlled Trial
The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.
The main questions it aims to answer are:
Read more
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda?
Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be:
- clinically examined for general health, anthropometric parameters including height and weight as well as temperature
- randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy
- checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration
- asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.
Read the detailed description
In view that efficacy of co-administered ivermectin (IVM) and albendazole (ALB) has been found to vary between different settings the rationale of this parallel open-label randomized controlled superiority trial is to provide evidence on the efficacy of co-administered ivermectin and albendazole compared to albendazole monotherapy in school-aged children aged 6-12 years against infection with T. trichiura in Uganda.
Our primary objective is to demonstrate superiority of
- Arm A: single dose of ivermectin (200 µg/kg, 3 mg tablets according to weight) / single dose of albendazole (400 mg tablet) combination, compared to
- Arm B: single dose of albendazole (400 mg tablet) in terms of cure rate (CR) against T. trichiura infections in school-aged children aged 6-12 years assessed at 14-21 days post-treatment by Kato-Katz microscopy.
The secondary objectives of the trial are:
- to determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura
- to determine the CRs and ERRs of the study drugs against Ascaris lumbricoides and hookworm in co-infected participants
- to evaluate the safety and tolerability of the treatment
The study will be implemented as a school-based study and children aged 6-12 years from two primary schools in Kabale district, southwestern Uganda will be invited for parasitological examination after obtaining informed consent from parents/caregivers and assent by the minor participants. Two stool samples will be collected, when possible, on two consecutive days. Children found to be infected with T. trichiura based on quadruplicate Kato-Katz thick smear readings will be enrolled into the actual trial. The medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study nurse/physician before treatment.
All participants will be interviewed before treatment and after 3 and 24 hours (active surveillance) for the occurrence of adverse events (AEs). Participants and their caregivers will be told that any potential AEs happening between 24 hours and the respective follow-up time point for stool collection should be reported to the local village health team (VHT) members, which will be trained to handle the situation by taking the participant to a health facility for timely treatment, or to local health workers directly.
The efficacy of the treatment will be determined at 14-21 days post-treatment by collecting another two stool samples.
At both, baseline and follow-up (14-21 days post treatment) a portion of stool (1.5-2 g) from all participants identified with T. trichiura infections will be preserved in 95% ethanol, shipped to a reference laboratory in Switzerland and subjected to amplicon deep sequencing for characterization of T. trichiura strains and investigation of potential resistance markers.
Study participants eligible for treatment will be randomly assigned to one of the two treatment arms stratified by 2 levels of baseline infection intensity (light: 1-999 EPG, and moderate plus heavy: ≥ 1000 EPG T. trichiura infections).
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs (between treatment arms) will be analyzed by using crude and adjusted logistic regression modeling.
Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.
- Conditions
- Trichuriasis
- Being tested
- IVM (200 µg/kg) + ALB (400 mg), ALB (400mg)
- Keywords
- Soil-transmitted helminths, Trichuris trichiura
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVM (200 µg/kg) + ALB (400 mg)Drug
Also called Zentel® and Stromectol®, Ivermectin Tablet 3mg
World Health Organization Pre-Qualification (WHO PQ) recommended ivermectin 3mg tablets will be used together with albendazole 400mg tablets as provided by WHO for Neglected Tropical Disease (NTD) programs.
ALB (400mg)Drug
Also called Zentel®
Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO
| Study group | Role | What they receive |
|---|---|---|
| IVM (200 µg/kg) + ALB (400 mg) | Experimental | A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose. Receives: Drug: IVM (200 µg/kg) + ALB (400 mg) |
| ALB (400mg) | Active comparator | A single tablet of albendazole (400mg), provided as single oral dose. Receives: Drug: ALB (400mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Measured: 14-21 days after treatment
Secondary outcomes (3)
Egg Reduction Rate (ERR) against T. Trichiura
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 after treatment
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Number of participants that converted from egg positive with Ascaris lumbricoides and/or hookworm infections to egg negative after 14-21 days.
Measured: 14-21 days after treatment
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections
Percent change in geometric mean eggs per gram of stool from before to after treatment. ERRs will be calculated for Ascaris lumbricoides and hookworm infections as described in outcome 2.
Measured: 14-21 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start9 Oct 2023
- Primary completion9 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel open-label randomized controlled superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037876
- Sponsor's protocol ID
- BRCCH PII 2021
- Acronym
- FACEITeffic
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2023
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palmeirim MS, Hurlimann E, Beinamaryo P, Kyarisiima H, Nabatte B, Hattendorf J, Steinmann P, Keiser J. Efficacy and safety of albendazole alone versus albendazole in combination with ivermectin for the treatment of Trichuris trichiura infections: An open-label, randomized controlled superiority trial in south-western Uganda. PLoS Negl Trop Dis. 2024 Nov 26;18(11):e0012687. doi: 10.1371/journal.pntd.0012687. eCollection 2024 Nov.
PubMed 39591454
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination Ivermectin and Albendazole vs Albendazole Alone in School-aged Children Infected With Trichuris Trichiura: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06037876
- Acronym / sponsor ID
- FACEITeffic / BRCCH PII 2021
- Conditions
- Trichuriasis
- Keywords
- Soil-transmitted helminths, Trichuris trichiura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Vector Borne & Neglected Tropical Disease Control Division, Ministry of Health, Uganda
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this parallel open-label randomized controlled superiority trial is to demonstrate that co-administered ivermectin (200 µg/kg) plus albendazole (400 mg) is superior to albendazole (400 mg) monotherapy in terms of cure rates against Trichuris trichiura infections assessed by Kato-Katz at 14-21 days post-treatment in individuals aged 6-12 years.
The main questions it aims to answer are:
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against T. trichiura infections in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole superior to albendazole alone in terms of cure rates and egg reduction rates against co-infecting soil-transmitted helminth infections such as Ascaris lumbricoides and hookworm in children aged 6-12 years in Uganda?
- Is single oral dose combined ivermectin-albendazole as tolerable and safe as albendazole monotherapy in children aged 6-12 years in Uganda?
Participants will be asked to provide two stool samples at baseline that will be subjected to microscopic analysis using the Kato-Katz thick smear technique for detection of soil-transmitted helminth eggs. T. trichiura-infected participants will be:
- clinically examined for general health, anthropometric parameters including height and weight as well as temperature
- randomly assigned to either receive one single oral dose of combined ivermectin and albendazole or albendazole monotherapy
- checked for any potential adverse events and will undergo a brief questionnaire on specific symptoms 3h after drug administration
- asked to provide another two stool samples to be microscopically examined for helminth eggs 14-21 days post-treatment Researchers will compare individuals treated with ivermectin-albendazole and albendazole alone to see if the proportion of T. trichiura egg-negative individuals and/or reduction in egg counts differs between these two groups 14-21 days after treatment.
Detailed description
In view that efficacy of co-administered ivermectin (IVM) and albendazole (ALB) has been found to vary between different settings the rationale of this parallel open-label randomized controlled superiority trial is to provide evidence on the efficacy of co-administered ivermectin and albendazole compared to albendazole monotherapy in school-aged children aged 6-12 years against infection with T. trichiura in Uganda.
Our primary objective is to demonstrate superiority of
- Arm A: single dose of ivermectin (200 µg/kg, 3 mg tablets according to weight) / single dose of albendazole (400 mg tablet) combination, compared to
- Arm B: single dose of albendazole (400 mg tablet) in terms of cure rate (CR) against T. trichiura infections in school-aged children aged 6-12 years assessed at 14-21 days post-treatment by Kato-Katz microscopy.
The secondary objectives of the trial are:
- to determine the egg reduction rates (ERRs) of ivermectin/albendazole combination therapy compared to albendazole monotherapy against T. trichiura
- to determine the CRs and ERRs of the study drugs against Ascaris lumbricoides and hookworm in co-infected participants
- to evaluate the safety and tolerability of the treatment
The study will be implemented as a school-based study and children aged 6-12 years from two primary schools in Kabale district, southwestern Uganda will be invited for parasitological examination after obtaining informed consent from parents/caregivers and assent by the minor participants. Two stool samples will be collected, when possible, on two consecutive days. Children found to be infected with T. trichiura based on quadruplicate Kato-Katz thick smear readings will be enrolled into the actual trial. The medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study nurse/physician before treatment.
All participants will be interviewed before treatment and after 3 and 24 hours (active surveillance) for the occurrence of adverse events (AEs). Participants and their caregivers will be told that any potential AEs happening between 24 hours and the respective follow-up time point for stool collection should be reported to the local village health team (VHT) members, which will be trained to handle the situation by taking the participant to a health facility for timely treatment, or to local health workers directly.
The efficacy of the treatment will be determined at 14-21 days post-treatment by collecting another two stool samples.
At both, baseline and follow-up (14-21 days post treatment) a portion of stool (1.5-2 g) from all participants identified with T. trichiura infections will be preserved in 95% ethanol, shipped to a reference laboratory in Switzerland and subjected to amplicon deep sequencing for characterization of T. trichiura strains and investigation of potential resistance markers.
Study participants eligible for treatment will be randomly assigned to one of the two treatment arms stratified by 2 levels of baseline infection intensity (light: 1-999 EPG, and moderate plus heavy: ≥ 1000 EPG T. trichiura infections).
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol analysis will be conducted. CRs will be calculated as the percentage of egg-positive subjects at baseline who become egg-negative after treatment. Differences among CRs (between treatment arms) will be analyzed by using crude and adjusted logistic regression modeling.
Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel open-label randomized controlled superiority trial
| Arm | Type | Receives |
|---|---|---|
| IVM (200 µg/kg) + ALB (400 mg) | Experimental | Drug: IVM (200 µg/kg) + ALB (400 mg)A single tablet of albendazole (400mg) plus 200 µg/kg of ivermectin, provided as single oral dose. |
| ALB (400mg) | Active comparator | Drug: ALB (400mg)A single tablet of albendazole (400mg), provided as single oral dose. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent for participation signed from caregivers; and written assent by participants.
- 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 nurse/physician prior to treatment.
- At least two slides of the quadruple Kato-Katz thick smears positive for T. trichiura.
Key exclusion criteria (4 listed)
- Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38°C, clinical malaria (fever + positive RDT) upon initial clinical assessment.
- Recent use of anthelmintic drug (within past 4 weeks).
- Attending other experimental research studies.
- Known allergy to study medications (i.e. benzimidazole or ivermectin).
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 |
|---|---|---|
| IVM (200 µg/kg) + ALB (400 mg)Also: Zentel® and Stromectol®, Ivermectin Tablet 3mgWorld Health Organization Pre-Qualification (WHO PQ) recommended ivermectin 3mg tablets will be used together with albendazole 400mg tablets as provided by WHO for Neglected Tropical Disease (NTD) programs. | Drug | IVM (200 µg/kg) + ALB (400 mg) |
| ALB (400mg)Also: Zentel®Albendazole 400mg manufactured and donated by GlaxoSmithKline (GSK) to WHO | Drug | ALB (400mg) |
Primary outcome
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured)
Time frame: 14-21 days after treatment
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
3 secondary outcomes
Egg Reduction Rate (ERR) against T. Trichiura
Time frame: 14-21 days after treatment
Number of Participants With Concomitant Soil-transmitted Helminth Infections Egg Negative Post-Treatment (Cured)
Time frame: 14-21 days after treatment
Egg-reduction Rates (ERRs) Against Concomitant Soil-transmitted Helminth Infections
Time frame: 14-21 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 39591454Palmeirim MS, Hurlimann E, Beinamaryo P, Kyarisiima H, Nabatte B, Hattendorf J, Steinmann P, Keiser J. Efficacy and safety of albendazole alone versus albendazole in combination with ivermectin for the treatment of Trichuris trichiura infections: An open-label, randomized controlled superiority trial in south-western Uganda. PLoS Negl Trop Dis. 2024 Nov 26;18(11):e0012687. doi: 10.1371/journal.pntd.0012687. eCollection 2024 Nov.
- Individual participant dataSharing planned: Undecided
Related trials for Trichuriasis
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
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?
A Phase 3 study testing IVM (200 µg/kg) + ALB (400 mg) and ALB (400mg) in people with Trichuriasis, run by Jennifer Keiser at 1 site in Uganda.
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 4 inclusion and 4 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 10 Apr 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 Uganda. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants T. Trichiura Egg Negative Post-Treatment (Cured) (time frame: 14-21 days after 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 NCT06037876, which also lists 1 linked publication.
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 10 Apr 2024.