A Phase 2 interventional study of Ivermectin and Albendazole in Trichuris Infection and Helminthiasis, sponsored by Alejandro Krolewiecki. Completed at 2 sites in 2 countries. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Alejandro Krolewiecki · Phase 2, Interventional, and Treatment
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
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 176 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →This is the only study on the registry with Alejandro Krolewiecki as lead sponsor.
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Exclusion Criteria:
Albendazole 400mg in single dose
Drug: Albendazole
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
Drug: Ivermectin · Drug: Albendazole
Albendazole 400mg/day for 3 consecutive days
Drug: Albendazole
Combination of albendazole 400mg/day + ivermectin 600mcg/kg/day for 3 consecutive days
Drug: Ivermectin · Drug: Albendazole
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.
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.
Time frame: 21 days
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).
Time frame: 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.
Time frame: 21days
| Milestone | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x 3 | Albendazole/Ivermectin x 3 |
|---|---|---|---|---|
| Started | 38 | 57 | 23 | 58 |
| Safety population | 38 | 56 | 23 | 58 |
| Completed | 24 | 35 | 18 | 40 |
| Not completed | 14 | 22 | 5 | 18 |
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.
| Participants | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x3 | Albendazole/Ivermectin x 3 |
|---|---|---|---|---|
| Cure Rate | 1 | 31 | 6 | 40 |
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).
| Percent change | Albendazole 400mg | Albendazole/Ivermectin | Albendazole x 3 | Albendazole/Ivermectin x 3 |
|---|---|---|---|---|
| Egg Change Rate | 50 | 97 | 72 | 100 |
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.
Results for this outcome have not been posted.
Collected over Adverse events were collected since the subject's enrollment until end of study participation (Day 21).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albendazole 400mg | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Albendazole/Ivermectin | 0/56 (0%) | 0/56 (0%) | 10/56 (17.9%) |
| Albendazole 400mg x3 | 0/23 (0%) | 0/23 (0%) | 7/23 (30.4%) |
| Albendazole/Ivermectin x 3 | 0/58 (0%) | 0/58 (0%) | 10/58 (17.2%) |
| Event | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x3 | Albendazole/Ivermectin x 3 |
|---|---|---|---|---|
| HeadacheGeneral disorders | 0/38 | 5/56 | 2/23 | 4/58 |
| Abdominal painGastrointestinal disorders | 0/38 | 4/56 | 2/23 | 4/58 |
| PhotophobiaEye disorders | 0/38 | 0/56 | 2/23 | 0/58 |
| PruritusSkin and subcutaneous tissue disorders | 0/38 | 0/56 | 1/23 | 1/58 |
| DiarrheaGastrointestinal disorders | 0/38 | 1/56 | 0/23 | 0/58 |
| VomitingGastrointestinal disorders | 0/38 | 0/56 | 0/23 | 1/58 |
| Age, Continuous(years) | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x 3 | Albendazole/Ivermectin x 3 | Total |
|---|---|---|---|---|---|
| Mean | 8.5 ± 2.6 | 8.0 ± 2.2 | 8.5 ± 2.0 | 8.0 ± 2.2 | 8.2 ± 2.3 |
| Sex: Female, Male(Participants) | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x 3 | Albendazole/Ivermectin x 3 | Total |
|---|---|---|---|---|---|
| Female | 19 | 24 | 13 | 30 | 86 |
| Male | 19 | 33 | 10 | 28 | 90 |
| Race and Ethnicity Not Collected(Participants) | Albendazole 400mg | Albendazole/Ivermectin | Albendazole 400mg x 3 | Albendazole/Ivermectin x 3 | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All IPD that underlie results in a publication.
Supporting information: Analytic code
Time frame: After study data analysis completion, with submission for publication to a peer review journal..
Access criteria: Database will be made available through a publication.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albendazole