Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Emodepside, Albendazole 400 mg.
- Who it may be relevant to
- Registry conditions: Trichuris Infection. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of a Single Dose of Emodepside Compared to a Single Dose of Albendazole in Adolescents and Adults Infected With Trichuris Incognita: a Phase II, Randomized, Double Blind, Controlled Trial
Overview
The purpose of this clinical trial is to compare the efficacy and safety of emodepside with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.
Interventions
- Drug Emodepside
Treatment with 15 mg of emodepside - Drug Albendazole 400 mg
Treatment with 400mg of albendazole
Primary outcome measures
- Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita [Time frame: Between 14-21 days post-treatment]
Secondary outcome measures (2)
- Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita [Time frame: Between 14-21 days post-treatment]
- Safety and tolerability [Time frame: 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment]
Eligibility criteria
Inclusion criteria
- Aged 12 years and above.
- Written informed consent signed by participant and, in the case of minors, parents/caregivers.
- Agree to comply with study procedures, including provision of two stool samples at the beginning (screening) and at follow-up assessment 14-21 days after treatment.
- Having at least two slides of the quadruple Kato-Katz thick smears positive for Trichuris incognita and infection intensities of at least 48 eggs per gram (EPG).
- Willing to be examined by a study physician prior to treatment.
Exclusion criteria
- Presence or signs of major systemic illnesses, e.g. body temperature ≥ 38 °C, severe anemia (Hb below 80g/l) upon initial clinical assessment etc.
- History of severe acute or unmanaged severe chronic disease (i.e., condition is not as therapeutically controlled as necessary).
- Positive malaria rapid diagnostic test (RDT) and temperature ≥ 38 °C.
- Abnormal liver and renal function assessed by biochemical blood-based analyses.
- Recent use of anthelmintic drugs (in the 4 weeks before treatment).
- Known allergy to study medications and formulations (i.e. albendazole and emodepside).
- Prescribed or taking medication with known contraindication to or interaction with study drugs.
- Participating in other clinical trials during the study period.
- Pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07258173 · EMODEPSIDE_CÔTE_D'IVOIRE