A Phase 3 interventional study of Placebo and Albendazole 400 mg in Trichuriasis, Strongyloidiasis and Ascariasis, sponsored by Mundo Sano Foundation. Not yet recruiting at 1 site in Honduras. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Mundo Sano Foundation · Phase 3, Interventional, and Treatment
The goal of this Phase III clinical trial is to evaluate the efficacy, safety, and acceptability of different treatment regimens for Trichuris trichiura infection in schoolchildren aged 6 to 15 years living in La Moskitia, Honduras, an area with a high burden of soil-transmitted helminth infections.
The main questions it aims to answer are:
Researchers will compare four treatment groups: placebo, albendazole alone, albendazole plus ivermectin, and a fixed-dose combination of albendazole plus ivermectin.
Participants will:
The study will provide evidence on the efficacy, safety, and acceptability of a fixed-dose combination of albendazole and ivermectin and its potential use as a simplified treatment strategy for the control of soil-transmitted helminth infections in endemic settings.
Soil-transmitted helminth (STH) infections remain among the most common neglected tropical diseases worldwide, affecting an estimated 1.5 billion people, particularly in tropical and subtropical regions with limited access to sanitation and healthcare. These infections are associated with anemia, malnutrition, impaired physical and cognitive development in children, and adverse pregnancy outcomes. Despite decades of preventive chemotherapy programs, STH infections continue to represent an important public health challenge in many endemic settings.
Current control strategies rely primarily on mass drug administration (MDA) using albendazole or mebendazole. While these medicines are effective against some STH species, their efficacy against Trichuris trichiura is limited, resulting in persistent transmission despite repeated treatment rounds. In addition, these regimens do not provide adequate treatment for Strongyloides stercoralis, a soil-transmitted helminth capable of causing chronic infection and severe complications in immunocompromised individuals.
Recognizing these limitations, the World Health Organization (WHO) Roadmap for Neglected Tropical Diseases 2021-2030 highlights the need for more effective interventions and strategies that can sustain progress toward the elimination of STHs as a public health problem. Combining existing anthelmintic drugs represents a practical and scalable approach to improving treatment efficacy while reducing the risk of emerging drug resistance.
Ivermectin has emerged as a key candidate for inclusion in integrated STH control strategies. The drug has an extensive record of safe use through large-scale public health programs targeting lymphatic filariasis and onchocerciasis and has been included in the WHO Model List of Essential Medicines. Clinical studies have shown that the combination of albendazole and ivermectin achieves substantially higher cure rates for T. trichiura than albendazole alone and also provides activity against S. stercoralis.
However, the operational use of ivermectin in preventive chemotherapy programs is complicated by the need for weight- or height-based dosing. This requirement increases logistical complexity, extends treatment time, and may result in dosing errors or exclusion of eligible individuals. To address these challenges, a fixed-dose combination (FDC) tablet containing albendazole and ivermectin has been developed. The FDC simplifies administration by providing a standardized dose in a single formulation while maintaining pharmacokinetic exposure comparable to co-administered drugs. Previous Phase II and Phase III studies have demonstrated promising efficacy and safety results, and the product has received a positive scientific opinion from the European Medicines Agency (EMA) for the treatment of multiple helminth infections.
Honduras represents an important setting for evaluating innovative treatment strategies against STHs. More than two million school-aged children require preventive chemotherapy, and T. trichiura remains highly prevalent despite repeated albendazole-based deworming campaigns. Previous studies conducted in Honduras have demonstrated improved efficacy of albendazole plus ivermectin compared with albendazole alone, providing a strong scientific foundation for further evaluation of combination regimens in this population.
The AIM-T study is designed to generate evidence on the efficacy, safety, and acceptability of albendazole-ivermectin combination therapies among schoolchildren living in La Moskitia, a highly endemic region in northeastern Honduras. The study will evaluate a novel fixed-dose combination formulation alongside currently available treatment approaches. In addition to measuring treatment outcomes, the study incorporates molecular diagnostics based on quantitative real-time polymerase chain reaction (qPCR), allowing highly sensitive detection of infections and quantitative assessment of parasite burden before and after treatment.
Participants with confirmed T. trichiura infection will receive a single-dose treatment regimen and will be followed for approximately three weeks. Treatment efficacy will be assessed through post-treatment stool examination using qPCR. Safety monitoring will include active, passive, and remote surveillance for adverse events following treatment. The study will also evaluate treatment acceptability among children and caregivers through structured questionnaires, generating evidence on user experience and preferences that may influence future implementation.
By combining efficacy, safety, and acceptability assessments, this study aims to generate evidence relevant to both clinical practice and public health programs. The findings are expected to inform policy decisions regarding the use of fixed-dose albendazole-ivermectin combinations in school-based and community-based deworming programs in Honduras and other STH-endemic settings. As the first evaluation of this fixed-dose combination in schoolchildren in the Americas, the study represents an important step in the pathway from clinical innovation to programmatic implementation. The results are expected to inform future community-based implementation studies and support the adoption of the intervention by national deworming programs in Honduras and, potentially, throughout the region.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's planned enrollment of 368 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Mundo Sano Foundation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single dose of a pediatric multivitamin tablet as placebo. Following completion of the study follow-up period (Day 21 ± 7), participants in this arm will receive active treatment with albendazole plus ivermectin.
Drug: Placebo
Participants will receive a single oral dose of albendazole 400 mg, the current standard treatment for soil-transmitted helminth infections.
Drug: Albendazole 400 mg
Participants will receive a single oral dose of albendazole 400 mg co-administered with ivermectin dosed according to body weight, following World Health Organization (WHO) dosing recommendations.
Drug: Albendazole Plus Ivermectin
Participants will receive a single oral dose of a fixed-dose combination (FDC) tablet containing albendazole 400 mg and ivermectin 9 mg.
Drug: Fixed-Dose Combination Albendazole/Ivermectin (FDC)
A single oral dose of a pediatric multivitamin tablet administered as placebo. The placebo contains no active anthelmintic ingredients and is used as a negative control to assess treatment efficacy and safety.
A single oral dose of albendazole 400 mg. Albendazole is the current standard treatment used in preventive chemotherapy programs for soil-transmitted helminth infections.
Drug pages: Albendazole · Ivermectin
A single oral dose of albendazole 400 mg co-administered with ivermectin dosed at 200 μg/kg according to participant body weight and World Health Organization (WHO) dosing recommendations. This regimen represents the current combination therapy shown to improve efficacy against Trichuris trichiura.
A single oral dose of a fixed-dose combination (FDC) tablet containing albendazole 400 mg and ivermectin 9 mg. The FDC is an investigational formulation designed to simplify administration by providing both drugs in a single tablet without the need for weight-based ivermectin dosing.
Trichuris trichiura Cure Rate
Proportion of participants with qPCR-confirmed Trichuris trichiura infection at baseline who test negative for T. trichiura by quantitative real-time PCR (qPCR) at the post-treatment assessment.
Time frame: Day 21 (± 7 days) after treatment
Reduction in Trichuris trichiura Parasite Burden
Change in Trichuris trichiura parasite burden measured by quantitative real-time PCR (qPCR) between baseline and post-treatment assessment. Parasite burden will be estimated using species-specific standard curves.
Time frame: Baseline and Day 21 (± 7 days) after treatment
Strongyloides stercoralis Cure Rate
Proportion of participants with qPCR-confirmed Strongyloides stercoralis infection at baseline who test negative by qPCR at the post-treatment assessment.
Time frame: Day 21 (± 7 days) after treatment
Cure Rate of Other Soil-Transmitted Helminths
Proportion of participants with qPCR-confirmed infection by Ancylostoma duodenale, Necator americanus, or Ascaris lumbricoides at baseline who test negative for the respective species by quantitative real-time PCR (qPCR) at the post-treatment assessment.
Time frame: Day 21 (± 7 days) after treatment
Reduction in Parasite Burden of Other Soil-Transmitted Helminths
Change in parasite burden of Strongyloides stercoralis, Ancylostoma duodenale, Necator americanus, and Ascaris lumbricoides between baseline and post-treatment assessment, measured by quantitative real-time PCR (qPCR). Parasite burden will be estimated using species-specific standard curves.
Time frame: Day 21 (± 7 days) after treatment
Safety Assessment
Incidence, type, severity, causality, and outcome of adverse events (AEs) and serious adverse events (SAEs) occurring after treatment administration of each treatment regimen.
Time frame: From treatment administration through Day 7 after treatment.
Treatment Acceptability
Acceptability of each treatment regimen among participants and caregivers, assessed using a structured post-treatment questionnaire evaluating satisfaction, preferences, and perceived ease of administration.
Time frame: Day 21 (± 7 days) after treatment
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in the primary study publication will be made available. Shared data will include participant-level baseline and follow-up infection status as determined by qPCR, treatment assignment, primary and secondary efficacy outcomes (including cure rates and parasite burden measurements), and safety data related to adverse events. All shared datasets will be fully de-identified to protect participant confidentiality and will be provided as supplementary material associated with the publication of the study results following study completion.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning upon publication of the primary study results and remaining available for at least 5 years.
Access criteria: The de-identified individual participant data (IPD) and supporting documentation will be available to anyone interested in accessing the study data, including researchers, healthcare professionals, policy makers, and members of the public. Available materials will include the de-identified participant-level dataset underlying the published results, data dictionaries, and other supporting documentation necessary to interpret the data. Data will be made available through the Figshare repository and may be accessed directly without restriction upon publication of the primary study results.
Data sharing details ↗ · figshare.com
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
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