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| Name | Class |
|---|---|
| Brock University | OTHER |
| Universidad Nacional del Centro de la Provincia de Buenos Aires | OTHER |
| Universidad Nacional Autonoma de Honduras | OTHER |
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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:
Total Study Population: 177
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albendazole 400mg | Active Comparator | Albendazole 400mg in single dose |
|
| Albendazole/Ivermectin | Experimental | Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose. |
|
| Albendazole 400mg x 3 | Experimental | Albendazole 400mg/day for 3 consecutive days |
|
| Albendazole/Ivermectin x 3 | Experimental | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 21 days |
| Beta Tubulin Resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro J Krolewiecki, MD, PhD | IIET - Universidad Nacional de Salta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IIET | Orán | Salta Province | 4530 | Argentina | ||
| Universidad Autónoma de Honduras |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39561184 | Derived | 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. | |
| 33906234 |
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All IPD that underlie results in a publication.
After study data analysis completion, with submission for publication to a peer review journal..
Database will be made available through a publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albendazole 400mg | Albendazole 400mg in single dose |
| FG001 | Albendazole/Ivermectin | Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose. |
| FG002 | Albendazole 400mg x 3 | Albendazole 400mg/day for 3 consecutive days. |
| FG003 | Albendazole/Ivermectin x 3 | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Albendazole 400mg | Albendazole 400mg in single dose |
| BG001 | Albendazole/Ivermectin | Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020. Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up. | Posted | Count of Participants | Participants | 21 days |
|
Adverse events were collected since the subject's enrollment until end of study participation (Day 21).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albendazole 400mg | Albendazole 400mg in single dose | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandro J Krolewiecki | Universidad Nacional de Salta | +54 911 3183-8673 | alekrol@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | May 26, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D006373 | Helminthiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Albendazole | Drug | Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin. |
|
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. |
| 21days |
| Tegucigalpa |
| Honduras |
| Matamoros 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. |
| BG002 | Albendazole 400mg x 3 | Albendazole 400mg/day for 3 consecutive days |
| BG003 | Albendazole/Ivermectin x 3 | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Albendazole/Ivermectin |
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose. |
| OG002 | Albendazole 400mg x3 | Albendazole 400mg/day for 3 consecutive days. |
| OG003 | Albendazole/Ivermectin x 3 | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days |
|
|
| Secondary | 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). | The follow-up visit for efficacy assessment on Day 21 post-drug administration was not conducted in 52 subjects due to the outbreak of COVID-19 pandemic in Honduras which precluded completion of study visits in March 2020. Additional 7 subjects did not complete the study: 1 did not take the study medication, and 6 subjects were lost to follow up. | Posted | Number | Percent change | 21 days |
|
|
|
| Secondary | 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. | Not Posted | 21days | Participants |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Albendazole/Ivermectin | Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose | 0 | 56 | 0 | 56 | 10 | 56 |
| EG002 | Albendazole 400mg x3 | Albendazole 400mg/day in 3 consecutive days | 0 | 23 | 0 | 23 | 7 | 23 |
| EG003 | Albendazole/Ivermectin x 3 | Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day in 3 consecutive days | 0 | 58 | 0 | 58 | 10 | 58 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Photophobia | Eye disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D007239 |
| Infections |
| D002219 |
| Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|