Phase 2
N=700
Albendazole Dose Finding and Pharmacokinetics in Children and Adults
Trichuriasis · Hookworm Infections
Bottom Line
View on ClinicalTrials.gov: NCT03527745 ↗Enrolled (actual)
700
Serious AEs
0.1%
Results posted
Jan 2021
Primary outcome: Primary: Cure Rate Against T. Trichiura and Hookworm Infections — 4; 2; 4; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Albendazole (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Jennifer Keiser
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure Rate Against T. Trichiura and Hookworm Infections |
4; 2; 4; 5; 3; 7 | — |
| SECONDARY Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively |
79.1; 63.8; 87.1; 88.5; 55.9; 82.0 | — |
| SECONDARY Maximum Concentration (Cmax) of Albendazole Sulphoxide |
3.41; 6.61; 9.98; 3.67; 5.51; 7.14 | — |
| SECONDARY Time to Reach Cmax (Tmax) of Albendazole Sulphoxide |
6.8; 6.8; 6.8; 7.1; 7.0; 7.1 | — |
| SECONDARY Area Under the Curve (AUC) of Albendazole Sulphoxide |
45.3; 90.3; 135.4; 47.3; 73.1; 96.9 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Male and female adults (≥21 years), preschool-aged children (2-5 years) and school-aged children (6-12 years) infected with T. trichiura/hookworm
- Written informed consent/assent signed from parent/guardian
- Positive for T. trichiura/hookworm by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
Exclusion Criteria
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment and liver function tests.
- Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
- Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned test article administration.
- Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
- Known or suspected allergy to benzimidazoles.
- Pregnant (urine testing) or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT03527745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.