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Trial record 55 of 106 for:    IVERMECTIN

Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients (HI4T)

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ClinicalTrials.gov Identifier: NCT04041453
Recruitment Status : Not yet recruiting
First Posted : August 1, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
Brock University, Department of Health Sciences. ON, Canada
UNCPBA, CIVETAN. Tandil, Argentina
Universidad Autonoma de Honduras, Instituto de Investigaciones en Microbiología. Tegucigalpa, Honduras
Information provided by (Responsible Party):
Alejandro Krolewiecki, Universidad Nacional de Salta

Brief 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). 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.

Reasons behind the existence of persistently high-prevalence areas have not been investigated in Honduras but they can range from structural and social drivers to host-related characteristics to parasite-specific factors. The present study aims to specifically look into the latter and therefore proposes:

  1. To determine whether zoonotic transmission of intestinal helminth parasites is occurring between humans and domestic animals (Ascaris spp and N. americanus in pigs and dogs, respectively)
  2. To establish if strains of T. trichiura and Ascaris lumbricoides circulating in humans carry genetic polymorphisms for drug resistance to benzimidazoles
  3. Conduct a preliminary analysis of epidemiological factors that might be related to the presence or absence of benzimidazole resistance and zoonotic infections

Condition or disease Intervention/treatment Phase
Trichuris Infection Helminthiasis Drug: Ivermectin Drug: Albendazole Phase 2

Detailed Description:

While waiting for their medical appointment, persons willing to enroll in the study will listen to a presentation about intestinal parasites (what are they, what they do to our health, and how to prevent them), and about the study, detailing benefits and risks. Depending on attendance and number of people volunteering to participate, this could be a small-group or individual activity lasting about 10 minutes.

Objective 1. To determine whether zoonotic transmission of intestinal helminth parasites is occurring between humans and domestic animals

  • A self-collected stool specimen will be requested from each participant (or their guardian) to be examined for STH eggs and other parasites (please note that as it is standard practice for medical brigades, Virginia Commonwealth University (VCU) brigade provides deworming treatment to all outpatients without laboratory tests, so our parasitological diagnosis will not affect the treatment decision (unless an unusual parasite for which the standard treatment provided by the brigade is not effective, the investigators will inform the health care providers so they can provide specific treatment (e.g., tapeworms)*
  • Participants who own or live in household owning dogs and / or pigs will be requested to provide a stool sample from at least one of these animals. In case of participant <18 years of age, the investigators would ask the parent/guardian to do this for their child.* Objective 2. To establish if circulating strains of T. trichiura carry genetic polymorphisms for drug resistance to benzimidazoles
  • "If according to the stool parasitological exam, a child is found heavily parasitized, the nurse at the health centre or the medical doctors from VCU medical brigade authorized by her will provide appropriate treatment. The child and their parents will be asked by researchers if they would like to collaborate by bringing 24-hr stool samples (entire evacuation of the day) during several days up to 7 days after medical treatment with the purpose of recovering the worms expelled. Worms and eggs found in the samples will be preserved for later analysis using molecular biology techniques." Objective 3
  • Responding to a short (5-7 minute) face-to-face questionnaire to collect demographic and household information (i.e., name, sex, address, age, level of education, and some epidemiological data such as history of infection with parasites and history of deworming, access to latrine or indoor toilet at home, owning dogs and owning pigs) *Stool sample collection instructions: briefly, participants will be provided with a clean unbreakable container labelled with the participant's code and the date of collection. They will also be provided with a disposable plastic "chamber pot" to take home and given instructions as to how to collect the sample into the pot and transfer a portion into the labelled container which they will place into a brown paper bag (provided) for privacy. The sample will be analyzed for the presence of intestinal helminth parasites by the formol-ether concentration technique. This technique allows preserving samples for transportation and later analysis the same day (since there is no electricity in the community, immediate examination of samples will not be possible).

For the 24-hr samples, special wide-mouth 2 L plastic containers with lid will be provided so the children can use them as chamber pots directly during the day.

In the case of animal samples, appropriate materials and instructions will be provided to the participants


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Parallel-group, Open-label Randomized Controlled Trial of Four Treatment Regimes for Trichuriasis in Pediatric Patients
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Albendazole 400mg
Albendazole 400mg in single dose
Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Experimental: Albendazole 400mg x 3
Albendazole 400mg in 3 consecutive days
Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Experimental: Albendazole/Ivermectin
Combination of albendazole 400mg + ivermectin 600mcg/kg in single dose.
Drug: Ivermectin
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.

Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.

Experimental: Albendazole/Ivermectin x 3
Combination of albendazole 400mg + ivermectin 600mcg/kg in 3 consecutive days
Drug: Ivermectin
Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.

Drug: Albendazole
Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.




Primary Outcome Measures :
  1. 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. Egg Reduction Rate [ Time Frame: 21 days ]
    Arithmetic mean of the reduction in number of eggs of Trichuris trichiura per gram of feces using the duplicate Kato Katz laboratory method on a single sample of fresh stools as the measurement tool.


Secondary Outcome Measures :
  1. Beta tubulin resistance [ Time Frame: 21days ]
    Measurement of the incidence of mutations of tubulin in Trichuris trichiura eggs collected pre and post treatment using molecular biology techniques.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection with T. trichiura by Kato Katz.
  • Body weight >15kg.
  • Accepts participation

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041453


Locations
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Argentina
IIET Not yet recruiting
Oran, Salta, Argentina, 4530
Contact: Alejandro J Krolewiecki, MD    +5491131838673    alekrol@hotmail.com   
Sponsors and Collaborators
Alejandro Krolewiecki
Brock University, Department of Health Sciences. ON, Canada
UNCPBA, CIVETAN. Tandil, Argentina
Universidad Autonoma de Honduras, Instituto de Investigaciones en Microbiología. Tegucigalpa, Honduras

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Responsible Party: Alejandro Krolewiecki, Investigador CIC CONICET, Universidad Nacional de Salta
ClinicalTrials.gov Identifier: NCT04041453     History of Changes
Other Study ID Numbers: 01-2019
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Krolewiecki, Universidad Nacional de Salta:
TRICHURIS
STH
IVERMECTIN
ALBENDAZOLE
Additional relevant MeSH terms:
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Ivermectin
Helminthiasis
Trichuriasis
Parasitic Diseases
Enoplida Infections
Adenophorea Infections
Nematode Infections
Albendazole
Antiparasitic Agents
Anti-Infective Agents
Anthelmintics
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents