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| Name | Class |
|---|---|
| Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg albendazole | Experimental | against T. trichiura in preschool-aged children or against hookworm infections in preschool-aged children, school-aged children and adults |
|
| 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 |
|
| 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 |
|
| 800 mg albendazole | Experimental | against T. trichiura in school-aged children and adults or against hookworm infections in school-aged children and adults |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug | Single dose of albendazole (200mg, dependent on treatment cohort) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 14-21 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14-21 days after treatment |
| Maximum Concentration (Cmax) of Albendazole Sulphoxide |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Suisse de Recherches Scientifiques en Côte d'Ivoire (CSRS) | Abidjan | Côte d’Ivoire |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32668456 | Derived | 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. | |
| 32405623 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Against T. Trichiura in PSAC | Placebo against T. trichiura in preschool-aged children |
| FG001 | ALB 200 mg Against T. Trichiura in PSAC | 200 mg of albendazole against T. trichiura in preschool-aged children |
| FG002 | ALB 400 mg Against T. Trichiura in PSAC | 400 mg of albendazole against T. trichiura in preschool-aged children |
| FG003 | ALB 600 mg Against T. Trichiura in PSAC | 600 mg of albendazole against T. trichiura in preschool-aged children |
| FG004 | Placebo Against T. Trichiura in SAC | Placebo against T. trichiura in school-aged children |
| FG005 | ALB 400 mg Against T. Trichiura in SAC | 400 mg of albendazole against T. trichiura in school-aged children |
| FG006 | ALB 600 mg Against T. Trichiura in SAC | 600 mg of albendazole against T. trichiura in school-aged children |
| FG007 | ALB 800 mg Against T. Trichiura in SAC | 800 mg of albendazole against T. trichiura in school-aged children |
| FG008 | Placebo Against T. Trichiura in Adults | Placebo against T. trichiura in adults |
| FG009 | ALB 400 mg Against T. Trichiura in Adults | 400 mg of albendazole against T. trichiura in adults |
| FG010 | ALB 600 mg Against T. Trichiura in Adults | 600 mg of albendazole against T. trichiura in adults |
| FG011 | ALB 800 mg Against T. Trichiura in Adults | 800 mg of albendazole against T. trichiura in adults |
| FG012 | Placebo Against Hookworm in PSAC | Placebo against hookworm in preschool-aged children |
| FG013 | ALB 200 mg Against Hookworm in PSAC | 200 mg of albendazole against hookworm in preschool-aged children |
| FG014 | ALB 400 mg Against Hookworm in PSAC | 400 mg of albendazole against hookworm in preschool-aged children |
| FG015 | ALB 600 mg Against Hookworm in PSAC | 600 mg of albendazole against hookworm in preschool-aged children |
| FG016 | Placebo Against Hookworm in SAC | Placebo against hookworm in school-aged children |
| FG017 | ALB 200 mg Against Hookworm in SAC | 200 mg of albendazole against hookworm in school-aged children |
| FG018 | ALB 400 mg Against Hookworm in SAC | 400 mg of albendazole against hookworm in school-aged children |
| FG019 | ALB 600 mg Against Hookworm in SAC | 600 mg of albendazole against hookworm in school-aged children |
| FG020 | ALB 800 mg Against Hookworm in SAC | 800 mg of albendazole against hookworm in school-aged children |
| FG021 | Placebo Against Hookworm in Adults | Placebo against hookworm in adults |
| FG022 | ALB 200 mg Against Hookworm in Adults | 200 mg of albendazole against hookworm in adults |
| FG023 | ALB 400 mg Against Hookworm in Adults | 400 mg of albendazole against hookworm in adults |
| FG024 | ALB 600 mg Against Hookworm in Adults | 600 mg of albendazole against hookworm in adults |
| FG025 | ALB 800 mg Against Hookworm in Adults | 800 mg of albendazole against hookworm in adults |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Placebo against hookworm in PSAC arm was removed from the trial after discussion with with principal investigators.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Against T. Trichiura in PSAC | Placebo against T. trichiura in preschool-aged children |
| BG001 | ALB 200 mg Against T. Trichiura in PSAC | 200 mg of albendazole against T. trichiura in preschool-aged children |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. | Posted | Count of Participants | Participants | 14-21 days after treatment |
|
Adverse events were collected at 3 hours and 24 hours after treatment.
After a lengthy period of recruitment, it was decided to eliminate the placebo group for the PSAC cohort against hookworm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Against T. Trichiura in PSAC | Placebo against T. trichiura in preschool-aged children |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient hospitalization due to clinical malaria | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Keiser, PhD | Swiss Tropical and Public Health Institute | +41 (61) 284 8218 | jennifer.keiser@swisstph.ch |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2018 | Aug 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D006725 | Hookworm Infections |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Albendazole | Drug | Single dose of albendazole (400mg, dependent on treatment cohort) |
|
|
| Albendazole | Drug | Single dose of albendazole (600mg, dependent on treatment cohort) |
|
|
| Albendazole | Drug | Single dose of albendazole (800mg, dependent on treatment cohort) |
|
|
| Placebo | Drug | Matching placebo tablets will be obtained from Fagron, Germany. |
|
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. |
| 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. | 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. | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
| 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. |
| BG002 | ALB 400 mg Against T. Trichiura in PSAC | 400 mg of albendazole against T. trichiura in preschool-aged children |
| BG003 | ALB 600 mg Against T. Trichiura in PSAC | 600 mg of albendazole against T. trichiura in preschool-aged children |
| BG004 | Placebo Against T. Trichiura in SAC | Placebo against T. trichiura in school-aged children |
| BG005 | ALB 400 mg Against T. Trichiura in SAC | 400 mg of albendazole against T. trichiura in school-aged children |
| BG006 | ALB 600 mg Against T. Trichiura in SAC | 600 mg of albendazole against T. trichiura in school-aged children |
| BG007 | ALB 800 mg Against T. Trichiura in SAC | 800 mg of albendazole against T. trichiura in school-aged children |
| BG008 | Placebo Against T. Trichiura in Adults | Placebo against T. trichiura in adults (>21 years) |
| BG009 | ALB 400 mg Against T. Trichiura in Adults | 400 mg of albendazole against T. trichiura in adults |
| BG010 | ALB 600 mg Against T. Trichiura in Adults | 600 mg of albendazole against T. trichiura in adults |
| BG011 | ALB 800 mg Against T. Trichiura in Adults | 800 mg of albendazole against T. trichiura in adults |
| BG012 | Placebo Against Hookworm in PSAC | Placebo against hookworm in preschool-aged children |
| BG013 | ALB 200 mg Against Hookworm in PSAC | 200 mg of albendazole against hookworm in preschool-aged children |
| BG014 | ALB 400 mg Against Hookworm in PSAC | 400 mg of albendazole against hookworm in preschool-aged children |
| BG015 | ALB 600 mg Against Hookworm in PSAC | 600 mg of albendazole against hookworm in preschool-aged children |
| BG016 | Placebo Against Hookworm in SAC | Placebo against hookworm in school-aged children |
| BG017 | ALB 200 mg Against Hookworm in SAC | 200 mg of albendazole against hookworm in school-aged children |
| BG018 | ALB 400 mg Against Hookworm in SAC | 400 mg of albendazole against hookworm in school-aged children |
| BG019 | ALB 600 mg Against Hookworm in SAC | 600 mg of albendazole against hookworm in school-aged children |
| BG020 | ALB 800 mg Against Hookworm in SAC | 800 mg of albendazole against hookworm in school-aged children |
| BG021 | Placebo Against Hookworm in Adults | Placebo against hookworm in adults (>21 years) |
| BG022 | ALB 200 mg Against Hookworm in Adults | 200 mg of albendazole against hookworm in adults |
| BG023 | ALB 400 mg Against Hookworm in Adults | 400 mg of albendazole against hookworm in adults |
| BG024 | ALB 600 mg Against Hookworm in Adults | 600 mg of albendazole against hookworm in adults |
| BG025 | ALB 800 mg Against Hookworm in Adults | 800 mg of albendazole against hookworm in adults |
| BG026 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| T. trichuris median eggs per gram | Median | Inter-Quartile Range | eggs per gram of stool |
|
| T. trichuris infection intensity | Count of Participants | Participants |
|
| hookworm median eggs per gram | Median | Inter-Quartile Range | eggs per gram of stool |
|
| hookworm infection intensity | Count of Participants | Participants |
|
| A. lumbricoides infection intensity | Count of Participants | Participants |
|
| OG002 | ALB 400 mg Against T. Trichiura in PSAC | 400 mg of albendazole against T. trichiura in preschool-aged children |
| OG003 | ALB 600 mg Against T. Trichiura in PSAC | 600 mg of albendazole against T. trichiura in preschool-aged children |
| OG004 | Placebo Against T. Trichiura in SAC | Placebo against T. trichiura in school-aged children |
| OG005 | ALB 400 mg Against T. Trichiura in SAC | 400 mg of albendazole against T. trichiura in school-aged children |
| OG006 | ALB 600 mg Against T. Trichiura in SAC | 600 mg of albendazole against T. trichiura in school-aged children |
| OG007 | ALB 800 mg Against T. Trichiura in SAC | 800 mg of albendazole against T. trichiura in school-aged children |
| OG008 | Placebo Against T. Trichiura in Adults | Placebo against T. trichiura in adults |
| OG009 | ALB 400 mg Against T. Trichiura in Adults | 400 mg of albendazole against T. trichiura in adults |
| OG010 | ALB 600 mg Against T. Trichiura in Adults | 600 mg of albendazole against T. trichiura in adults |
| OG011 | ALB 800 mg Against T. Trichiura in Adults | 800 mg of albendazole against T. trichiura in adults |
| OG012 | Placebo Against Hookworm in PSAC | Placebo against hookworm in preschool-aged children |
| OG013 | ALB 200 mg Against Hookworm in PSAC | 200 mg of albendazole against hookworm in preschool-aged children |
| OG014 | ALB 400 mg Against Hookworm in PSAC | 400 mg of albendazole against hookworm in preschool-aged children |
| OG015 | ALB 600 mg Against Hookworm in PSAC | 600 mg of albendazole against hookworm in preschool-aged children |
| OG016 | Placebo Against Hookworm in SAC | Placebo against hookworm in school-aged children |
| OG017 | ALB 200 mg Against Hookworm in SAC | 200 mg of albendazole against hookworm in school-aged children |
| OG018 | ALB 400 mg Against Hookworm in SAC | 400 mg of albendazole against hookworm in school-aged children |
| OG019 | ALB 600 mg Against Hookworm in SAC | 600 mg of albendazole against hookworm in school-aged children |
| OG020 | ALB 800 mg Against Hookworm in SAC | 800 mg of albendazole against hookworm in school-aged children |
| OG021 | Placebo Against Hookworm in Adults | Placebo against hookworm in adults |
| OG022 | ALB 200 mg Against Hookworm in Adults | 200 mg of albendazole against hookworm in adults |
| OG023 | ALB 400 mg Against Hookworm in Adults | 400 mg of albendazole against hookworm in adults |
| OG024 | ALB 600 mg Against Hookworm in Adults | 600 mg of albendazole against hookworm in adults |
| OG025 | ALB 800 mg Against Hookworm in Adults | 800 mg of albendazole against hookworm in adults |
|
|
| Secondary | 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 | An analysis set of all randomized participants who provided any follow-up data was used to perform an available-case analysis. | Posted | Geometric Mean | 95% Confidence Interval | percent change | 14-21 days after treatment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mikromol/L | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | hours | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | micogram/ml/h-1 | 0, 1, 2, 3, 4, 6, 8, 24 hours post-dosing |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 3 |
| 27 |
| EG001 | ALB 200 mg Against T. Trichiura in PSAC | 200 mg of albendazole against T. trichiura in preschool-aged children | 0 | 27 | 1 | 27 | 2 | 27 |
| EG002 | ALB 400 mg Against T. Trichiura in PSAC | 400 mg of albendazole against T. trichiura in preschool-aged children | 0 | 30 | 0 | 30 | 3 | 30 |
| EG003 | ALB 600 mg Against T. Trichiura in PSAC | 600 mg of albendazole against T. trichiura in preschool-aged children | 0 | 27 | 0 | 27 | 2 | 27 |
| EG004 | Placebo Against T. Trichiura in SAC | Placebo against T. trichiura in school-aged children | 0 | 46 | 0 | 46 | 4 | 46 |
| EG005 | ALB 400 mg Against T. Trichiura in SAC | 400 mg of albendazole against T. trichiura in school-aged children | 0 | 45 | 0 | 45 | 9 | 45 |
| EG006 | ALB 600 mg Against T. Trichiura in SAC | 600 mg of albendazole against T. trichiura in school-aged children | 0 | 46 | 0 | 46 | 8 | 46 |
| EG007 | ALB 800 mg Against T. Trichiura in SAC | 800 mg of albendazole against T. trichiura in school-aged children | 0 | 43 | 0 | 43 | 8 | 43 |
| EG008 | Placebo Against T. Trichiura in Adults | Placebo against T. trichiura in adults | 0 | 10 | 0 | 10 | 3 | 10 |
| EG009 | ALB 400 mg Against T. Trichiura in Adults | 400 mg of albendazole against T. trichiura in adults | 0 | 11 | 0 | 11 | 3 | 11 |
| EG010 | ALB 600 mg Against T. Trichiura in Adults | 600 mg of albendazole against T. trichiura in adults | 0 | 9 | 0 | 9 | 2 | 9 |
| EG011 | ALB 800 mg Against T. Trichiura in Adults | 800 mg of albendazole against T. trichiura in adults | 0 | 12 | 0 | 12 | 2 | 12 |
| EG012 | Placebo Against Hookworm in PSAC | Placebo against hookworm in preschool-aged children | 0 | 0 | 0 | 0 | 0 | 0 |
| EG013 | ALB 200 mg Against Hookworm in PSAC | 200 mg of albendazole against hookworm in preschool-aged children | 0 | 13 | 0 | 13 | 1 | 13 |
| EG014 | ALB 400 mg Against Hookworm in PSAC | 400 mg of albendazole against hookworm in preschool-aged children | 0 | 13 | 0 | 13 | 0 | 13 |
| EG015 | ALB 600 mg Against Hookworm in PSAC | 600 mg of albendazole against hookworm in preschool-aged children | 0 | 12 | 0 | 12 | 1 | 12 |
| EG016 | Placebo Against Hookworm in SAC | Placebo against hookworm in school-aged children | 0 | 24 | 0 | 24 | 2 | 24 |
| EG017 | ALB 200 mg Against Hookworm in SAC | 200 mg of albendazole against hookworm in school-aged children | 0 | 27 | 0 | 27 | 3 | 27 |
| EG018 | ALB 400 mg Against Hookworm in SAC | 400 mg of albendazole against hookworm in school-aged children | 0 | 27 | 0 | 27 | 2 | 27 |
| EG019 | ALB 600 mg Against Hookworm in SAC | 600 mg of albendazole against hookworm in school-aged children | 0 | 29 | 0 | 29 | 1 | 29 |
| EG020 | ALB 800 mg Against Hookworm in SAC | 800 mg of albendazole against hookworm in school-aged children | 0 | 26 | 0 | 26 | 3 | 26 |
| EG021 | Placebo Against Hookworm in Adults | Placebo against hookworm in adults | 0 | 40 | 0 | 40 | 2 | 40 |
| EG022 | ALB 200 mg Against Hookworm in Adults | 200 mg of albendazole against hookworm in adults | 0 | 41 | 0 | 41 | 4 | 41 |
| EG023 | ALB 400 mg Against Hookworm in Adults | 400 mg of albendazole against hookworm in adults | 0 | 38 | 0 | 38 | 5 | 38 |
| EG024 | ALB 600 mg Against Hookworm in Adults | 600 mg of albendazole against hookworm in adults | 0 | 40 | 0 | 40 | 3 | 40 |
| EG025 | ALB 800 mg Against Hookworm in Adults | 800 mg of albendazole against hookworm in adults | 0 | 37 | 0 | 37 | 4 | 37 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Infections and infestations | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|
| Moderate (1000-9999 epg) |
|
| Heavy (>= 10000 epg) |
|
| Not infected |
|
| Moderate (2000-3999 epg) |
|
| Heavy (>= 4000 epg) |
|
| Not infected |
|
| Moderate (5000-49999 epg) |
|
| Heavy (>= 50000 epg) |
|
| Not infected |
|