Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03465488
• Date of registration: 16/02/2018
• Prospective Registration: No
• Primary sponsor: University Ghent
• Public title: Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance StarwormsWP1
• Scientific title: Validation of Both Automated Quality Assured Egg Counting System and Molecular Markers for Monitoring the Spread of Anthelmintic Resistance.
• Date of first enrolment: August 15, 2016
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03465488
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Brazil, Ethiopia, Lao People's Democratic Republic, Tanzania

Contacts

• Name: Bruno Levecke, PhD
• Affiliation: University Ghent

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject, male or female, is 5-14 years of age

- Subject is otherwise in an healthy condition (medical history and physical
examination)

- Parent(s)/guardians of subjects (or their legally-accepted representatives) signed an
informed consent document indicating that they understand the purpose of and
procedures required for the study and are willing to have their child participate in
the study.

- Subject of =6 years has assented (agreed) to participate in the study.

- Subject of =12 has signed an informed consent document indicating that they understand
the purpose of and procedures required for the study and are willing to participate in
the study.

- The subject swallowed the entire drug (ALB 400 mg) under supervision

- Subject provides a stool sample of at least 9 grams

Exclusion Criteria:

- Subject has active diarrhea (defined as the passage of 3 or more loose or liquid
stools per day) at baseline or follow-up

- Subject has any acute medical condition or is experiencing a severe concurrent medical
condition

- Subject has a known hypersensitivity to benzimidazole drugs

- Subject has received an anthelminthic treatment within 90 of the start of the
treatment.

- Subject vomited within 4 hours after drug administration

- Subject is unable to provide a stool sample at follow-up



Age minimum: 5 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Soil-transmitted Helminth Infections

Intervention(s)

Drug: Albendazole Pill 400mg (GSK)

Primary Outcome(s)

Validation of the performance of FECPAKG2 to assess drug efficacy [Time Frame: up to 12 months]

In depth evaluation of the FECPAKG2 technique to assess drug efficacy [Time Frame: up to 12 months]

Validation of b-tubulin gene as a molecular marker for benzimidazole resistance [Time Frame: up to 24 months]

Secondary Outcome(s)

Comparing the use of individual and pooled stool samples to assess polymorphisms in the ß-tubulin gene. [Time Frame: up to 24 months]

Comparing the sensitivity of quantitative PCR with traditional diagnostic tools (Kato-Katz, Mini-FLOTAC and FECPAKG2) for the detection of soil-transmitted helminth infections. [Time Frame: up to 12 months]

Secondary ID(s)

OPP1120972

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Swiss Tropical & Public Health Institute