Hookworm Infections
Conditions
Keywords
Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth
Brief summary
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
Interventions
DRUGEmodepside
Treatment with Emodepside 30 mg
Treatment with Albendazole 400 mg
Sponsors
Public Health Laboratory Ivo de Carneri
Jennifer Keiser
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
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. * Participated in stage I trials of this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 | — |
Countries
Tanzania
Outcome results
None listed