Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03527745 |
| Other study ID # |
2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
October 23, 2018 |
| Est. completion date |
April 17, 2019 |
Study information
| Verified date |
May 2023 |
| Source |
Swiss Tropical & Public Health Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a single-blind randomized clinical trial conducted in rural Côte d'Ivoire. This
study aims at providing evidence on the dose-response of increasing oral albendazole dosages
against whipworm (T. trichiura) and hookworm infections in preschoolers (2-5 years),
school-aged children (6-12 years) and adults (≥ 21 years).
The primary objective is to determine cure rates (primary end point, i.e. conversion from
being egg positive pre-treatment to egg negative post-treatment). Secondary objectives
involve the determination of egg reduction rates (the reduction in the number of excreted
eggs from baseline (prior to treatment) to follow-up) and the assessment of safety of
ascending dosages of albendazole (secondary end points). In addition, key pharmacokinetic
parameters will be determined from blood samples collected with a micro-sampling device
(secondary end point).
Description:
This study is a single-blind randomized clinical trial conducted in Côte d'Ivoire. This study
aims at providing evidence on the efficacy and safety of ascending oral albendazole dosages
in children and adults infected with T. trichiura and hookworm. In preschool-aged children
(2-5 years) (i) 200 mg, (ii) 400 mg and (iii) 600 mg; in schoolchildren (6-12 years) and
adults (≥ 21 years) (i) 200 mg (only for hookworm infections), (ii) 400 mg, (iii) 600 mg and
(iv) 800 mg will be administered and efficacy, safety and pharmacokinetic parameters will be
assessed.
The primary objective is to determine the dose-response based on cure rates of albendazole in
preschool-aged children (2-5 years), school-aged children (6-12 years) and adults (≥ 21
years) infected with T. trichiura and hookworm.
The secondary objectives of the trial are to determine the efficacy based on egg reduction
rates of albendazole in preschool-aged children, school-aged children and adults, to
determine an exposure (including length of time that the drug concentration is above the MIC,
Cmax, AUC)-response correlation of albendazole in preschool-aged children, school-aged
children and adults, to evaluate the safety and tolerability of albendazole in preschool-aged
children, school-aged children and adults, and to determine the efficacy against concomitant
soil-transmitted helminthiasis (Ascaris lumbricoides).
After obtaining informed consent from individual/parents and/or caregiver, the medical
history of the participants will be assessed with a standardized questionnaire, in addition
to a clinical examination and venipuncture to examine biochemical parameters in the blood
carried out by the study physician before treatment. Enrollment will be based on two stool
samples that will be collected, if possible, on two consecutive days or otherwise within a
maximum of 5 days.
All stool samples will be examined with duplicated Kato-Katz thick smears by experienced
laboratory technicians. Randomization of participants into the treatment arms will be
stratified according to intensity of infection. All participants will be interviewed before
treatment, 3 and 24 hours and 3 weeks after treatment about the occurrence of adverse events.
Children and adults will be sampled using finger pricking for micro-blood sampling at 0, 1,
2, 3, 4, 6, 8, 24 hours post-dosing.
The primary analysis will include all participants with primary end point data (available
case analysis). Supplementary, a per-protocol analysis and an intention-to-treat analysis
will be conducted. CRs will be calculated as the percentage of egg-positive subjects at
baseline who become egg-negative after treatment. Differences among CRs will be analysed by
using crude logistic regressions and adjusted logistic regressions (adjustment for age, sex,
and height).
Geometric and arithmetic mean egg counts will be calculated for the different treatment arms
before and after treatment to assess the corresponding ERRs. Bootstrap resampling method with
2,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in
ERRs. Noncompartmental and nonlinear mixed-effects (NLME) modeling will be used to determine
PK parameters.
