Trichuris InfectionPhase 2HI4TNCT04041453
Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
A Phase 2 study testing Ivermectin and Albendazole in people with Trichuris Infection and Helminthiasis, run by Alejandro Krolewiecki at 2 sites in 2 countries.
Trial summary
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). Read more about this study
- Who is it for?
- Ages 2 to 14 years
- Conditions the study is for
- Trichuris Infection, Helminthiasis
- What is being tested?
- Ivermectin and Albendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Oct 2019to 7 Mar 2020
- Phase
- Phase 2
- 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 2 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infection with T. trichiura by Kato Katz.
- Body weight >15kg.
- Accepts participation
Who cannot join
- Albendazole and/or mebendazol treatment in the previous 3 months.
- Allergy to the study drugs
- Acute medical conditions
- Clinical trial participation in the previous 3 months.
- Pregnancy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over two billion people and contribute to significant morbidity and disability, especially in high risk groups, for example children, agricultural workers and pregnant women. In children, STH are associated with impaired nutritional status evidenced by stunting, thinness and underweight.
As is the case in most Latin America, STH are a public health problem in Honduras. The World Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age) in the country are at risk of infection. To control these infections Honduras has established a national deworming program that operates since 2001 but despite these efforts, the prevalence of STH infections remains unacceptably high. This is especially true in rural communities where prevalence can be as high as 70% of the children population.
Read more
Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to improve efficacy compared to any of these drugs in monotherapy; the efficacy is however, still inadequate in terms of cure rate, although egg reduction rates are significant.
The purpose of the current trial is to assess the safety and efficacy of 3 experimental regimens for the treatment of infections by Trichuris trichiura in children in comparison with the current standard of practice in Mass Drug Administration (MDA) campaigns. The experimental regimens will explore the effect of multiple day regimens and high dose ivermectin.
Treatment arms:
- Group 1: single dose of ALB 400 mg. (active control arm). N:39
- Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57
- Group 3: daily dose ALB 400mg for 3 consecutive days. N:24
- Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57
Total Study Population: 177
- Conditions
- Trichuris Infection, Helminthiasis
- Being tested
- Ivermectin, Albendazole
- Keywords
- TRICHURIS, STH, IVERMECTIN, ALBENDAZOLE
- Medical subject headings
- Trichuriasis, Helminthiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.
AlbendazoleDrug
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.
| Study group | Role | What they receive |
|---|---|---|
| Albendazole 400mg | Active comparator | Albendazole 400mg in single dose Receives: Drug: Albendazole |
| Albendazole/Ivermectin | Experimental | Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose. Receives: Drug: Ivermectin; Drug: Albendazole |
| Albendazole 400mg x 3 | Experimental | Albendazole 400mg/day for 3 consecutive days Receives: Drug: Albendazole |
| Albendazole/Ivermectin x 3 | Experimental | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days Receives: Drug: Ivermectin; Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate
Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.
Measured: 21 days
Secondary outcomes (2)
Egg Change Rate
Calculation details: 100 x (1 - arithmetic mean fecal egg count post-intervention / arithmetic mean fecal egg count pre-intervention) Egg change rate was calculated across all participants, as described in reference: Levecke B et al., PLoS Negl Trop Dis. 2014;8(10).
Measured: 21 days
Beta Tubulin Resistance
Measurement of the incidence of mutations of tubulin in Trichuris trichiura eggs collected pre and post treatment using molecular biology techniques.
This data is not available yet due to the COVID-19 pandemic, but the data will be available and reported in the future. Anticipated reporting date for this outcome measure is estimated by 2021 and will be confirmed once the pandemic is over.
Measured: 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start9 Oct 2019
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
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 Trichuris InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alejandro Krolewiecki
- Sponsor type
- University, hospital or other
- Collaborators
- Brock University, Universidad Nacional del Centro de la Provincia de Buenos Aires, Universidad Nacional Autonoma de Honduras
- Responsible party
- Sponsor-investigator, Alejandro Krolewiecki, Universidad Nacional de Salta
- Investigators
- Alejandro J Krolewiecki, MD, PhD, Study director, IIET - Universidad Nacional de Salta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041453
- Sponsor's protocol ID
- 01-2019
- Acronym
- HI4T
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2019
- Last updated
- 29 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Matamoros G, Sanchez A, Cimino R, Krolewiecki A, Mejia R. A comparison of the diagnostic capability of Kato-Katz and real-time PCR for the assessment of treatment efficacy of ivermectin and albendazole combination against T. trichiura infections. PLoS Negl Trop Dis. 2024 Nov 19;18(11):e0012677. doi: 10.1371/journal.pntd.0012677. eCollection 2024 Nov.
PubMed 39561184Matamoros G, Sanchez A, Gabrie JA, Juarez M, Ceballos L, Escalada A, Rodriguez C, Marti-Soler H, Rueda MM, Canales M, Lanusse C, Cajal P, Alvarez L, Cimino RO, Krolewiecki A. Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):1203-1210. doi: 10.1093/cid/ciab365.
PubMed 33906234
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04041453
- Acronym / sponsor ID
- HI4T / 01-2019
- Conditions
- Trichuris Infection, Helminthiasis
- Keywords
- TRICHURIS, STH, IVERMECTIN, ALBENDAZOLE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Alejandro KrolewieckiUniversity, hospital or other
- Collaborators
- Brock University, Universidad Nacional del Centro de la Provincia de Buenos Aires, Universidad Nacional Autonoma de Honduras
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 29 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura (whipworms). These parasites affect over two billion people and contribute to significant morbidity and disability, especially in high risk groups, for example children, agricultural workers and pregnant women. In children, STH are associated with impaired nutritional status evidenced by stunting, thinness and underweight.
As is the case in most Latin America, STH are a public health problem in Honduras. The World Health Organization (WHO) informs that more than 2.5 million children (under 15 years of age) in the country are at risk of infection. To control these infections Honduras has established a national deworming program that operates since 2001 but despite these efforts, the prevalence of STH infections remains unacceptably high. This is especially true in rural communities where prevalence can be as high as 70% of the children population.
Ivermectin (IVM) in combination with albendazole (ALB) has demonstrated the capacity to improve efficacy compared to any of these drugs in monotherapy; the efficacy is however, still inadequate in terms of cure rate, although egg reduction rates are significant.
The purpose of the current trial is to assess the safety and efficacy of 3 experimental regimens for the treatment of infections by Trichuris trichiura in children in comparison with the current standard of practice in Mass Drug Administration (MDA) campaigns. The experimental regimens will explore the effect of multiple day regimens and high dose ivermectin.
Treatment arms:
- Group 1: single dose of ALB 400 mg. (active control arm). N:39
- Group 2: single dose ALB 400mg + IVM 600µg/Kg. N: 57
- Group 3: daily dose ALB 400mg for 3 consecutive days. N:24
- Group 4: daily dose ALB 400mg + IVM 600µg for 3 consecutive days. N:57
Total Study Population: 177
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Albendazole 400mg | Active comparator | Drug: AlbendazoleAlbendazole 400mg in single dose |
| Albendazole/Ivermectin | Experimental | Drug: Ivermectin, Drug: AlbendazoleCombination of albendazole 400mg + ivermectin 600mcg/kg in single dose. |
| Albendazole 400mg x 3 | Experimental | Drug: AlbendazoleAlbendazole 400mg/day for 3 consecutive days |
| Albendazole/Ivermectin x 3 | Experimental | Drug: Ivermectin, Drug: AlbendazoleCombination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infection with T. trichiura by Kato Katz.
- Body weight >15kg.
- Accepts participation
Key exclusion criteria (5 listed)
- Albendazole and/or mebendazol treatment in the previous 3 months.
- Allergy to the study drugs
- Acute medical conditions
- Clinical trial participation in the previous 3 months.
- Pregnancy.
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 |
|---|---|---|
| IvermectinIvermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days. | Drug | Albendazole/Ivermectin, Albendazole/Ivermectin x 3 |
| AlbendazoleAlbendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin. | Drug | Albendazole 400mg, Albendazole 400mg x 3, Albendazole/Ivermectin, Albendazole/Ivermectin x 3 |
Primary outcome
Cure Rate
Time frame: 21 days
Number of individuals cured from Trichuris trichiura infection using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool. Cure rate is defined as the absence of Trichuris trichiura eggs in post-treatment samples.
2 secondary outcomes
Egg Change Rate
Time frame: 21 days
Beta Tubulin Resistance
Time frame: 21days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39561184Matamoros G, Sanchez A, Cimino R, Krolewiecki A, Mejia R. A comparison of the diagnostic capability of Kato-Katz and real-time PCR for the assessment of treatment efficacy of ivermectin and albendazole combination against T. trichiura infections. PLoS Negl Trop Dis. 2024 Nov 19;18(11):e0012677. doi: 10.1371/journal.pntd.0012677. eCollection 2024 Nov.
- Derived from this study: PubMed 33906234Matamoros G, Sanchez A, Gabrie JA, Juarez M, Ceballos L, Escalada A, Rodriguez C, Marti-Soler H, Rueda MM, Canales M, Lanusse C, Cajal P, Alvarez L, Cimino RO, Krolewiecki A. Efficacy and Safety of Albendazole and High-Dose Ivermectin Coadministration in School-Aged Children Infected With Trichuris trichiura in Honduras: A Randomized Controlled Trial. Clin Infect Dis. 2021 Oct 5;73(7):1203-1210. doi: 10.1093/cid/ciab365.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Alejandro J Krolewiecki, MD, PhD study director
IIET - Universidad Nacional de Salta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin and Albendazole in people with Trichuris Infection and Helminthiasis, run by Alejandro Krolewiecki at 2 sites in 2 countries.
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 3 inclusion and 5 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Honduras. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jul 2020). 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?
Cure Rate (time frame: 21 days). 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 NCT04041453, 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 29 Jul 2020.