TrichuriasisPhase 2NCT03527745
Albendazole Dose Finding and Pharmacokinetics in Children and Adults
A Phase 2 study testing Albendazole in people with Trichuriasis and Hookworm Infections, run by Jennifer Keiser at 1 site in Côte d’Ivoire.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Trichuriasis, Hookworm Infections
- What is being tested?
- Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 23 Oct 2018to 17 Apr 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site
Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
Abidjan
About this study
Official title: Efficacy and Safety of Ascending Dosages of Albendazole Against T. Trichiura and Hookworm in Preschool- and School-aged Children and Adults: a Randomized Controlled Trial
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).
Read the detailed 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.
- Conditions
- Trichuriasis, Hookworm Infections
- Being tested
- Albendazole, Placebo
- Medical subject headings
- Trichuriasis, Hookworm Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Also called Zentel®
Single dose of albendazole (200mg, dependent on treatment cohort)
AlbendazoleDrug
Also called Zentel®
Single dose of albendazole (400mg, dependent on treatment cohort)
AlbendazoleDrug
Also called Zentel®
Single dose of albendazole (600mg, dependent on treatment cohort)
AlbendazoleDrug
Also called Zentel®
Single dose of albendazole (800mg, dependent on treatment cohort)
PlaceboDrug
Matching placebo tablets will be obtained from Fagron, Germany.
| Study group | Role | What they receive |
|---|---|---|
| 200 mg albendazole | Experimental | against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults Receives: Drug: Albendazole |
| 400 mg albendazole | Experimental | against T. trichiura in preschool-aged children, school-aged children and adults or against hookworm infections in preschool-aged children, school-aged children and adults Receives: Drug: Albendazole |
| 600 mg albendazole | Experimental | against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults Receives: Drug: Albendazole |
| 800 mg albendazole | Experimental | against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults Receives: Drug: Albendazole |
| Placebo | Placebo comparator | against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate Against T. Trichiura and Hookworm Infections
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
Measured: 14-21 days after treatment
Secondary outcomes (4)
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively
Percent change in geometric mean eggs per gram of stool from before to after treatment
Measured: 14-21 days after treatment
Maximum Concentration (Cmax) of Albendazole Sulphoxide
To determine maximum drug concentration (Cmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide 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 foreseen limit of quantification of approximately 1-5 ng/ml.
Measured: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide
To determine time to reach Cmax (tmax) of albendazole and its metabolites in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole sulfoxide was 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 foreseen limit of quantification of approximately 1-5 ng/ml.
Measured: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Area Under the Curve (AUC) of Albendazole Sulphoxide
To determine the area under the curve (AUC) of albendazole sulphoxide in adults (≥ 21 years), preschool-aged (2-5 years) and school-aged children (6-12 years). Albendazole and its metabolites (albendazole sulfoxide and albendazole sulfone) 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 foreseen limit of quantification of approximately 1-5 ng/ml.
Measured: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start23 Oct 2018
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TrichuriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527745
- Sponsor's protocol ID
- 2
- Status last verified
- May 2023
- First submitted
- 3 May 2018
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Patel C, Coulibaly JT, Hofmann D, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and Safety of Albendazole in Hookworm-infected Preschool-aged Children, School-aged Children, and Adults in Cote d'Ivoire: A Phase 2 Randomized, Controlled Dose-finding Trial. Clin Infect Dis. 2021 Jul 15;73(2):e494-e502. doi: 10.1093/cid/ciaa989.
PubMed 32668456Patel C, Coulibaly JT, Schulz JD, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and safety of ascending dosages of albendazole against Trichuris trichiura in preschool-aged children, school-aged children and adults: A multi-cohort randomized controlled trial. EClinicalMedicine. 2020 May 5;22:100335. doi: 10.1016/j.eclinm.2020.100335. eCollection 2020 May.
PubMed 32405623
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ascending Dosages of Albendazole Against T. Trichiura and Hookworm in Preschool- and School-aged Children and Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03527745
- Acronym / sponsor ID
- 2
- Conditions
- Trichuriasis, Hookworm Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 200 mg albendazole | Experimental | Drug: Albendazoleagainst T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults |
| 400 mg albendazole | Experimental | Drug: Albendazoleagainst T. trichiura in preschool-aged children, school-aged children and adults or against hookworm infections in preschool-aged children, school-aged children and adults |
| 600 mg albendazole | Experimental | Drug: Albendazoleagainst T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults |
| 800 mg albendazole | Experimental | Drug: Albendazoleagainst T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults |
| Placebo | Placebo comparator | Drug: Placeboagainst T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbendazoleAlso: Zentel®Single dose of albendazole (200mg, dependent on treatment cohort) | Drug | 200 mg albendazole |
| AlbendazoleAlso: Zentel®Single dose of albendazole (400mg, dependent on treatment cohort) | Drug | 400 mg albendazole |
| AlbendazoleAlso: Zentel®Single dose of albendazole (600mg, dependent on treatment cohort) | Drug | 600 mg albendazole |
| AlbendazoleAlso: Zentel®Single dose of albendazole (800mg, dependent on treatment cohort) | Drug | 800 mg albendazole |
| PlaceboMatching placebo tablets will be obtained from Fagron, Germany. | Drug | Placebo |
Primary outcome
Cure Rate Against T. Trichiura and Hookworm Infections
Time frame: 14-21 days after treatment
The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).
4 secondary outcomes
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively
Time frame: 14-21 days after treatment
Maximum Concentration (Cmax) of Albendazole Sulphoxide
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Area Under the Curve (AUC) of Albendazole Sulphoxide
Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32668456Patel C, Coulibaly JT, Hofmann D, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and Safety of Albendazole in Hookworm-infected Preschool-aged Children, School-aged Children, and Adults in Cote d'Ivoire: A Phase 2 Randomized, Controlled Dose-finding Trial. Clin Infect Dis. 2021 Jul 15;73(2):e494-e502. doi: 10.1093/cid/ciaa989.
- Derived from this study: PubMed 32405623Patel C, Coulibaly JT, Schulz JD, N'Gbesso Y, Hattendorf J, Keiser J. Efficacy and safety of ascending dosages of albendazole against Trichuris trichiura in preschool-aged children, school-aged children and adults: A multi-cohort randomized controlled trial. EClinicalMedicine. 2020 May 5;22:100335. doi: 10.1016/j.eclinm.2020.100335. eCollection 2020 May.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albendazole in people with Trichuriasis and Hookworm Infections, run by Jennifer Keiser at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate Against T. Trichiura and Hookworm Infections (time frame: 14-21 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527745, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.