Hookworm Infections Clinical Trial
— IverpedOfficial title:
Efficacy, Safety and Acceptability of Ascending Doses of Ivermectin in Combination With Albendazole for Trichuris Trichiura Infections in Preschool-aged Children: a Single-blind Randomised Controlled Dose-ranging Trial
NCT number | NCT06184399 |
Other study ID # | Iverped_1 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 5, 2024 |
Est. completion date | August 2024 |
This study is a single-blind randomized controlled dose-ranging trial aiming at providing evidence on the on the optimal dose of co-administered ivermectin and albendazole in terms of efficacy, safety and acceptability in preschool-aged children (PSAC; aged 2-5 years) infected with whipworm (Trichuris trichiura) on Pemba Island, Tanzania. Additionally, the pharmacokinetics of the newly developed ODTs and the standard ivermectin tablets (Stromectol®) will be compared in this age group. As measure of efficacy of the treatment the cure rate (percentage of egg-positive participants at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility | Inclusion Criteria: - individuals aged 2-5 years (24-71 months; confirmed by birth certificate or similar document) - having given written informed consent signed by parents/caregivers - being able and willing to provide two stool samples at baseline and at follow-up assessment (14-21 days) - having at least two out of four Kato-Katz slides positive for T. trichiura at baseline - being able and willing to be examined by a study physician before and after treatment Exclusion Criteria: - presence or signs of major systemic illness, e.g. fever (temporal body temperature of >38.0°C), severe anaemia (haemoglobin level of <70 g/l) - history of severe acute disease or unmanaged, severe chronic disease (i.e., condition is not as therapeutically controlled as necessary) - use of anthelminthic drugs during study period - known allergy to study medication (i.e., ivermectin or albendazole) - being prescribed or taking concomitantly medication with known contraindications or drug interactions with the study medication - concurrent participation in other clinical trials |
Country | Name | City | State |
---|---|---|---|
Tanzania | Public Health Laboratory Ivo de Carneri | Chake Chake |
Lead Sponsor | Collaborator |
---|---|
Jennifer Keiser | Public Health Laboratory Ivo de Carneri |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood concentration of ivermectin | For characterization of population pharmacokinetics (PK), ivermectin concentration will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a lower limit of quantification of 1-5 ng/ml. | 0 to 24 hours post-treatment | |
Other | Acceptability of ODT assessed by visual analogue scale (0-100 mm) | To determine the acceptability of ivermectin ODTs compared to standard tablets, the palatability of each formulation will be rated by children aged 4-5 years using a visual analogue scale with continuous scores from 0 mm (worst taste) to 100 mm (best taste). | 15 min post-treatment | |
Primary | Cure rate (CR) against T. trichiura | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment | |
Secondary | Egg reduction rate (ERR) against T. trichiura | 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days post-treatment | |
Secondary | Cure rate (CR) against A. lumbricoides | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment | |
Secondary | Egg reduction rate (ERR) against A. lumbricoides | 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days post-treatment | |
Secondary | Cure rate (CR) against Hookworm | The CR will be calculated as the proportion of participants converting from being egg-positive pre-treatment to egg-negative post-treatment. | 14-21 days post-treatment | |
Secondary | Egg reduction rate (ERR) against Hookworm | 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. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days post-treatment | |
Secondary | Number of participants reporting adverse events (AEs) | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. | 3 hours, 24 hours and 14-21 days post-treatment |
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