Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
- Registration Number
- NCT05538767
- Lead Sponsor
- Jennifer Keiser
- Brief Summary
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
- Male or female adults aged between 12 and 60 years;
- Written and signed informed consent;
- Was examined by a study physician before treatment;
- Provided two stool samples at baseline;
- Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one 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.
- Participated in stage I trials of this protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Emodepside 30 mg Emodepside - Albendazole 400 mg Albendazole 400mg -
- Primary Outcome Measures
Name Time Method 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 Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2. At baseline and 14-21 days post-treatment Geometric Mean Egg Reduction Rate (ERR) of the emodepside against 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).
CR of emodepside against Trichuris trichiura and Ascaris lumbricoides In the week between 14 and 21 days post-treatment CR will be calculated as the percentage of Trichuris trichiura and Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides. In the week between 14 and 21 days post-treatment 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 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, Pemba, Tanzania