ClinicalTrials.gg
CompletedNCT03527745Updated Jun 12, 2023Results posted

Albendazole Dose Finding and Pharmacokinetics in Children and Adults

A Phase 2 interventional study of Albendazole and Albendazole in Trichuriasis and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Côte D'Ivoire. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2023-06-12.

Sponsored by Jennifer Keiser · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Trichuriasis
  • Hookworm Infections
03

In context

Trichuriasis

30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.

This study's enrollment of 700 is above the median of 315 across 27 interventional studies indexed under Trichuriasis.

Browse Trichuriasis studies →

Lead sponsor

Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female adults (≥21 years), preschool-aged children (2-5 years) and school-aged children (6-12 years) infected with T. trichiura/hookworm
  2. Written /assent signed from parent/guardian
  3. 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)
  4. 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

Exclusion Criteria:

  1. 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.
  2. Known or reported history of chronic illness such as , acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
  3. Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin, mebendazole or albendazole) within 4 weeks before planned test article administration.
  4. Received any drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
  5. Known or suspected allergy to benzimidazoles.
  6. Pregnant (urine testing) or breastfeeding women
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
700 participants (actual)

Study arms

  • Experimental
    200 mg albendazole

    against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults

    Drug: Albendazole

  • Experimental
    400 mg albendazole

    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

    Drug: Albendazole

  • Experimental
    600 mg albendazole

    against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults

    Drug: Albendazole

  • Experimental
    800 mg albendazole

    against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults

    Drug: Albendazole

  • Placebo comparator
    Placebo

    against T. trichiura in preschool-aged children, school-aged children and adults or hookworm infections in preschool-aged children, school-aged children and adults

    Drug: Placebo

Interventions

  • Single dose of albendazole (200mg, dependent on treatment cohort)

    Also known as: Zentel®

  • Single dose of albendazole (400mg, dependent on treatment cohort)

    Also known as: Zentel®

  • Single dose of albendazole (600mg, dependent on treatment cohort)

    Also known as: Zentel®

  • Single dose of albendazole (800mg, dependent on treatment cohort)

    Also known as: Zentel®

  • DrugPlacebo

    Matching placebo tablets will be obtained from Fagron, Germany.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 14-21 days after treatment

Secondary outcomes

  1. 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

    Time frame: 14-21 days after treatment

  2. 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.

    Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

  3. 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.

    Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

  4. 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.

    Time frame: 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing

07

Results

Posted Jan 6, 2021

Participant flow

Participant flow — Overall Study
MilestonePlacebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Started27273027464546431011912013131224272729264041384037
Completed242123184643434179811013131223272728253535303934
Not completed36790232321100001001156813
Withdrew: Lost to follow-up36790232321100001001156813

Outcome measures

PrimaryCure Rate Against T. Trichiura and Hookworm Infections

The conversion from being egg positive pre-treatment to egg negative post-treatment, or cure rate (CR).

Time frame:
14-21 days after treatment
Reported as:
Count of participants · Participants
Cure Rate Against T. Trichiura and Hookworm Infections
ParticipantsPlacebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Cured4245371171543—98101017201819516162232
Not cured20191913433632346448—45213107106301914172
SecondaryEgg-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

Time frame:
14-21 days after treatment
Reported as:
Geometric mean · percent change
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively
percent changePlacebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Egg-reduction Rate (ERR) Against T. Trichiura and Hookworm Infections, Respectively79.1 (53.5 to 91.2)63.8 (33.1 to 83.1)87.1 (67.3 to 95.3)88.5 (70.4 to 95.7)55.9 (26.1 to 75.2)82.0 (67.8 to 90.5)88.4 (74.8 to 94.8)78.7 (60.5 to 89.1)85.2 (65.9 to 95.3)97.7 (86.7 to 99.8)94.7 (61.0 to 99.6)92.6 (71.9 to 98.5)—99.0 (94.7 to 99.9)96.2 (83.5 to 99.4)99.6 (98.5 to 100.0)90.6 (72.3 to 97.3)97.7 (93.5 to 99.3)99.0 (97.4 to 99.7)98.3 (95.4 to 99.5)98.4 (95.9 to 99.6)33.0 (-27.1 to 67.3)93.8 (87.0 to 97.3)95.8 (90.2 to 98.3)97.0 (92.5 to 98.9)99.8 (99.5 to 100.0)
SecondaryMaximum 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.

Time frame:
0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Reported as:
Mean · mikromol/L
Maximum Concentration (Cmax) of Albendazole Sulphoxide
mikromol/LALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Maximum Concentration (Cmax) of Albendazole Sulphoxide3.41 ± 2.586.61 ± 4.569.98 ± 7.163.67 ± 2.545.51 ± 3.7787.14 ± 4.822.03 ± 1.442.95 ± 1.894.03 ± 2.621.70 ± 1.283.27 ± 2.284.98 ± 3.611.02 ± 0.742.11 ± 1.563.16 ± 2.414.12 ± 3.210.61 ± 0.441.22 ± 0.911.78 ± 1.202.43 ± 1.71
SecondaryTime 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.

Time frame:
0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Reported as:
Mean · hours
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide
hoursALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Time to Reach Cmax (Tmax) of Albendazole Sulphoxide6.8 ± 4.46.8 ± 3.86.8 ± 4.17.1 ± 4.67.0 ± 4.47.1 ± 4.37.3 ± 4.37.2 ± 4.37.4 ± 4.54.2 ± 2.74.2 ± 2.44.2 ± 2.64.5 ± 2.84.7 ± 3.14.7 ± 3.04.8 ± 3.05.3 ± 3.25.3 ± 3.25.4 ± 3.35.4 ± 3.4
SecondaryArea 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.

Time frame:
0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing
Reported as:
Mean · micogram/ml/h-1
Area Under the Curve (AUC) of Albendazole Sulphoxide
micogram/ml/h-1ALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Area Under the Curve (AUC) of Albendazole Sulphoxide45.3 ± 31.490.3 ± 58.7135.4 ± 89.647.3 ± 27.773.1 ± 44.296.9 ± 58.326.99 ± 15.940.2 ± 23.453.4 ± 29.916.6 ± 10.133.1 ± 18.849.5 ± 28.511.4 ± 6.722.3 ± 13.434.5 ± 22.145.2 ± 29.07.4 ± 4.014.9 ± 8.022.3 ± 12.129.8 ± 15.7

Adverse events

Collected over Adverse events were collected at 3 hours and 24 hours after treatment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Against T. Trichiura in PSAC0/27 (0%)0/27 (0%)3/27 (11.1%)
ALB 200 mg Against T. Trichiura in PSAC0/27 (0%)1/27 (3.7%)2/27 (7.4%)
ALB 400 mg Against T. Trichiura in PSAC0/30 (0%)0/30 (0%)3/30 (10%)
ALB 600 mg Against T. Trichiura in PSAC0/27 (0%)0/27 (0%)2/27 (7.4%)
Placebo Against T. Trichiura in SAC0/46 (0%)0/46 (0%)4/46 (8.7%)
ALB 400 mg Against T. Trichiura in SAC0/45 (0%)0/45 (0%)9/45 (20%)
ALB 600 mg Against T. Trichiura in SAC0/46 (0%)0/46 (0%)8/46 (17.4%)
ALB 800 mg Against T. Trichiura in SAC0/43 (0%)0/43 (0%)8/43 (18.6%)
Placebo Against T. Trichiura in Adults0/10 (0%)0/10 (0%)3/10 (30%)
ALB 400 mg Against T. Trichiura in Adults0/11 (0%)0/11 (0%)3/11 (27.3%)
ALB 600 mg Against T. Trichiura in Adults0/9 (0%)0/9 (0%)2/9 (22.2%)
ALB 800 mg Against T. Trichiura in Adults0/12 (0%)0/12 (0%)2/12 (16.7%)
Placebo Against Hookworm in PSAC———
ALB 200 mg Against Hookworm in PSAC0/13 (0%)0/13 (0%)1/13 (7.7%)
ALB 400 mg Against Hookworm in PSAC0/13 (0%)0/13 (0%)0/13 (0%)
ALB 600 mg Against Hookworm in PSAC0/12 (0%)0/12 (0%)1/12 (8.3%)
Placebo Against Hookworm in SAC0/24 (0%)0/24 (0%)2/24 (8.3%)
ALB 200 mg Against Hookworm in SAC0/27 (0%)0/27 (0%)3/27 (11.1%)
ALB 400 mg Against Hookworm in SAC0/27 (0%)0/27 (0%)2/27 (7.4%)
ALB 600 mg Against Hookworm in SAC0/29 (0%)0/29 (0%)1/29 (3.4%)
ALB 800 mg Against Hookworm in SAC0/26 (0%)0/26 (0%)3/26 (11.5%)
Placebo Against Hookworm in Adults0/40 (0%)0/40 (0%)2/40 (5%)
ALB 200 mg Against Hookworm in Adults0/41 (0%)0/41 (0%)4/41 (9.8%)
ALB 400 mg Against Hookworm in Adults0/38 (0%)0/38 (0%)5/38 (13.2%)
ALB 600 mg Against Hookworm in Adults0/40 (0%)0/40 (0%)3/40 (7.5%)
ALB 800 mg Against Hookworm in Adults0/37 (0%)0/37 (0%)4/37 (10.8%)
Most frequent serious events
Most frequent serious events
EventPlacebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
Inpatient hospitalization due to clinical malariaInfections and infestations0/271/270/300/270/460/450/460/430/100/110/90/12—0/130/130/120/240/270/270/290/260/400/410/380/400/37
Most frequent other events
Most frequent other events
EventPlacebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in Adults
HeadacheNervous system disorders1/272/273/300/273/461/453/465/431/103/112/92/12—1/130/131/121/241/270/270/290/262/403/414/382/401/37
Abdominal painGastrointestinal disorders1/270/271/302/274/464/453/467/432/103/111/90/12—0/130/130/121/242/272/271/293/260/401/411/382/403/37
NauseaGastrointestinal disorders0/270/270/300/270/460/450/460/430/101/110/90/12—0/130/130/120/240/270/270/290/260/400/410/380/401/37
ItchingSkin and subcutaneous tissue disorders0/270/270/300/270/461/451/460/430/100/110/91/12—0/130/130/120/240/270/270/290/260/400/410/380/400/37
DiarrheaInfections and infestations1/270/272/301/272/463/451/460/430/100/110/90/12—0/130/130/120/240/270/270/290/260/400/410/380/400/37
VomitingGastrointestinal disorders0/270/270/300/271/460/450/460/430/100/110/90/12—0/130/130/120/240/270/270/290/260/400/410/380/400/37

Baseline characteristics

The Placebo against hookworm in PSAC arm was removed from the trial after discussion with with principal investigators.

Age, Continuous
Age, Continuous(years)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Age4.1 ± 0.94.0 ± 0.93.8 ± 1.14.0 ± 0.98.9 ± 1.98.9 ± 1.98.7 ± 2.08.8 ± 1.844.3 ± 12.340.5 ± 11.936.6 ± 12.244.8 ± 15.9—3.8 ± 1.23.8 ± 1.33.8 ± 1.19.1 ± 2.29.1 ± 1.99.8 ± 1.99.2 ± 2.29.4 ± 2.335.4 ± 10.339.8 ± 12.236.3 ± 12.239.2 ± 11.535.7 ± 12.017.7 ± 16.3
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Female16181618251519176978—598812857716779282
Male119149213027264224—84416151924193325313328418
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Count of participants——————————————————————————0
T. trichuris median eggs per gram
T. trichuris median eggs per gram(eggs per gram of stool)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Median216 (120 to 438)264 (96 to 558)210 (144 to 510)228 (150 to 726)387 (222 to 1068)426 (192 to 1266)507 (186 to 1134)414 (162 to 1116)138 (114 to 270)168 (114 to 504)156 (114 to 288)195 (150 to 402)—0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)294 (162 to 972)
T. trichuris infection intensity
T. trichuris infection intensity(Participants)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Light (1-999 epg)22222421323031301010910—0012200210001260
Moderate (1000-9999 epg)4556141515120102—000000000000079
Heavy (>= 10000 epg)101000010000—00000000000003
Not infected000000000000—13131122252729243941384036358
hookworm median eggs per gram
hookworm median eggs per gram(eggs per gram of stool)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Median0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)0 (0 to 0)—216 (150 to 618)126 (60 to 540)252 (111 to 423)183 (78 to 450)126 (72 to 336)138 (78 to 246)156 (84 to 528)153 (66 to 366)157 (96 to 318)126 (54 to 444)96 (54 to 264)189 (63 to 570)114 (84 to 216)132 (66 to 369)
hookworm infection intensity
hookworm infection intensity(Participants)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Light (1-1999 epg)001011231100—12121122262727243840384036363
Moderate (2000-3999 epg)000000000000—111210202100112
Heavy (>= 4000 epg)000000000000—00000002000002
Not infected2727292745444440910912—0000000000000323
A. lumbricoides infection intensity
A. lumbricoides infection intensity(Participants)Placebo Against T. Trichiura in PSACALB 200 mg Against T. Trichiura in PSACALB 400 mg Against T. Trichiura in PSACALB 600 mg Against T. Trichiura in PSACPlacebo Against T. Trichiura in SACALB 400 mg Against T. Trichiura in SACALB 600 mg Against T. Trichiura in SACALB 800 mg Against T. Trichiura in SACPlacebo Against T. Trichiura in AdultsALB 400 mg Against T. Trichiura in AdultsALB 600 mg Against T. Trichiura in AdultsALB 800 mg Against T. Trichiura in AdultsPlacebo Against Hookworm in PSACALB 200 mg Against Hookworm in PSACALB 400 mg Against Hookworm in PSACALB 600 mg Against Hookworm in PSACPlacebo Against Hookworm in SACALB 200 mg Against Hookworm in SACALB 400 mg Against Hookworm in SACALB 600 mg Against Hookworm in SACALB 800 mg Against Hookworm in SACPlacebo Against Hookworm in AdultsALB 200 mg Against Hookworm in AdultsALB 400 mg Against Hookworm in AdultsALB 600 mg Against Hookworm in AdultsALB 800 mg Against Hookworm in AdultsTotal
Light (1-4999 epg)223288460102—101110100001044
Moderate (5000-49999 epg)262159670201—000000000000041
Heavy (>= 50000 epg)000001000000—00000000000001
Not infected231925243327363010899—12131123262728264041383937614
08

Study locations

1 site
  • Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS)
    Abidjan, Côte D'Ivoire
09

References and documents

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 32668456 ↗
  • Patel 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03527745
Lead sponsor
Jennifer Keiser
Collaborators
Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
Responsible party
Jennifer Keiser (Prof. Jennifer Keiser, PhD, Swiss Tropical & Public Health Institute) — Sponsor-investigator
First posted
May 17, 2018
Start date
Oct 23, 2018
Primary completion
Apr 17, 2019
Completion
Apr 17, 2019
Results posted
Jan 6, 2021
Last update
Jun 12, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Albendazole

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