Trichuris Trichiura; Infection, Hookworm Infections
Conditions
Keywords
Emodepside, Trichuris trichiura, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Dose selection
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.
Interventions
DRUGEmodepside
Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
Sponsors
Public Health Laboratory Ivo de Carneri
Jennifer Keiser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Countries
Tanzania
Outcome results
None listed