Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm
- Conditions
- Hookworm InfectionsTrichuris Trichiura; Infection
- Interventions
- Registration Number
- NCT05017194
- Lead Sponsor
- Jennifer Keiser
- Brief Summary
The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
- Male or female adults aged between 18 and 45 years
- Written and signed informed consent
- Examined by a study physician before treatment
- Provided two stool samples at baseline
- Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs
- Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
- Type 1 and/or 2 diabetes
- Psychiatric disorders
- History of ophthalmological conditions
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
- Suffers from severe anaemia (Hb < 80 g/l)
- Received anthelminthic treatment within past four weeks
- Attending other clinical trials during the study
- Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
- Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albendazole Emodepside - Emodepside 15 mg Emodepside - Emodepside 5 mg Emodepside - Emodepside 10 mg Emodepside - Emodepside 20 mg Emodepside - Emodepside 25 mg Emodepside - Emodepside 30 mg Emodepside - Placebo Emodepside -
- Primary Outcome Measures
Name Time Method Cure rate (CR) of emodepside against Trichuris trichiura In the week between 14 and 21 days post-treatment CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment.
Cure rate (CR) of emodepside against hookworm In the week between 14 and 21 days post-treatment CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
- Secondary Outcome Measures
Name Time Method CR against Ascaris lumbricoides In the week between 14 and 21 days post-treatment CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
ERR against Ascaris lumbricoides In the week between 14 and 21 days post-treatment Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against Trichuris trichiura and hookworm. In the week between 14 and 21 days post-treatment Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))\*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)\*100).
Trial Locations
- Locations (1)
Public Health Laboratory - Ivo de Carneri
🇹🇿Chake Chake, Tanzania