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| Name | Class |
|---|---|
| Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | OTHER |
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This study is a double-blind randomized controlled superiority trial aiming at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standard of care) against whipworm (T. trichiura) infections in adolescents and adults (12-60 years) in Côte d'Ivoire. One arm of patients will be treated with albendazole-ivermectin.
As measure of efficacy of the treatment the cure rate (percentage of egg-positive subjects at baseline who become egg-negative after treatment) will be determined 14-21 days post-treatment.
This study is a double-blind randomized clinical trial which aims at providing evidence on the efficacy and safety of co-administered moxidectin and albendazole versus albendazole monotherapy (standard of care) against T. trichiura infections in adolescents and adults (12-60 years) in Côte d'Ivoire. Additionally, this study aims to substantiate evidence on the efficacy and safety of co-administered ivermectin and albendazole compared to albendazole monotherapy against T. trichiura in the same age group.
The primary objective of the trial is to comparatively assess the efficacy in terms of cure rate (CR) against T. trichiura infections among adolescents and adults (aged 12 to 60 years) of moxidectin/albendazole combination therapy and albendazole monotherapy.
The secondary objectives of the trial are to compare the egg reduction rates (ERR) of these treatment regimens (moxidectin/albendazole combination therapy vs. albendazole monotherapy) against T. trichiura, to assess the CRs and ERRs in T. trichiura-infected participants given ivermectin/albendazole combination therapy compared to those given albendazole monotherapy, to determine the CRs and ERRs of the drugs in study participants co-infected with A. lumbricoides and hookworm, and to evaluate the safety and tolerability of the treatment regimens. In addition, this study aims to characterize population pharmacokinetics and drug-drug interactions of the study drugs albendazole and ivermectin in T. trichiura infected adolescents (aged 12 to 20 years), to evaluate pharmacogenomics of ivermectin using whole genome sequencing, and to assess the effect of the gut microbiota on pharmacokinetics parameters and treatment outcome (CRs and ERRs), and drug-specific off-target effects of anthelmintic treatment on gut microbial communities in post-treatment samples.
After obtaining informed consent from individual/parents and/or caregivers, the medical history of the participants will be assessed with a standardized questionnaire, in addition to a clinical examination carried out by the study physician before treatment. Enrollment will be based on two stool samples, which 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 three treatment arms will be stratified according to intensity of infection. All participants will be interviewed before treatment, 3 and 24 hours and 14-21 days after treatment about the occurrence of adverse events. The efficacy of the treatment will be determined 14-21 days post-treatment by collecting another two stool samples.
The primary analysis will include all participants with primary end point data (available case analysis). Supplementary, a per-protocol 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 between treatment arms will be analysed using crude and adjusted logistic regression modeling (adjustment for age, sex and weight).
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 5,000 replicates will be used to calculate 95% confidence intervals (CIs) for differences in ERRs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: moxidectin and albendazole | Experimental | Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm B: albendazole | Placebo Comparator | Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Arm C: ivermectin and albendazole | Experimental | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin 2 mg Oral Tablet | Drug | Tablets of 2 mg moxidectin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | 14-21 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years) | For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites 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 lower limit of quantification of 1-5 ng/ml. |
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 |
|---|---|---|---|
| 37357904 | Derived | Sprecher VP, Coulibaly JT, Hurlimann E, Hattendorf J, Keiser J. Efficacy and Safety of Moxidectin-Albendazole and Ivermectin-Albendazole Combination Therapy Compared to Albendazole Monotherapy in Adolescents and Adults Infected with Trichuris trichiura: A Randomized, Controlled Superiority Trial. Clin Infect Dis. 2023 Nov 11;77(9):1294-1302. doi: 10.1093/cid/ciad387. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Moxidectin and Albendazole | Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG001 | Arm B: Albendazole | Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| FG002 | Arm C: Ivermectin and Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Moxidectin and Albendazole | Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | Available case analysis | Posted | Number | 95% Confidence Interval | percentage of participants (%) | 14-21 days after treatment |
|
14-21 days
Participants were monitored at the site for 3 hours following treatment for any acute adverse events and reassessment was done at 24 hours post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs.
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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 | Arm A: Moxidectin and Albendazole | Combination therapy of moxidectin (8 mg, i.e. 4 tablets of 2 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Moxidectin 2 mg Oral Tablet: Tablets of 2 mg moxidectin Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Dr Jennifer Keiser | Swiss Tropical and Public Health Institute | +41 61 284 82 18 | jennifer.keiser@swisstph.ch |
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| 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 | May 6, 2021 | Sep 1, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D001196 | Ascariasis |
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C027837 | moxidectin |
| D013607 | Tablets |
| D015766 | Albendazole |
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
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The parallel group trial co-administered moxidectin/albendazole versus albendazole alone will be double blinded (i.e. study participants and the trial team/researchers conducting the treatment and assessing the outcomes will be blinded) using tablets including appearance-matched placebos, while the ivermectin/albendazole arm will be open label due to the nature of ivermectin (i.e. requiring bodyweight-dependent doses).
| Albendazole 400 mg Oral Tablet |
| Drug |
Tablets of 400 mg albendazole |
|
|
| Ivermectin 3 mg Oral Tablet | Drug | Tablets of 3 mg ivermectin |
|
|
| 14-21 days after treatment |
| Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | 14-21 days after treatment |
| Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days after treatment |
| Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | 14-21 days after treatment |
| Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days after treatment |
| Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | 14-21 days after treatment |
| Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. | 14-21 days after treatment |
| Number of Participants Reporting Adverse Events (AEs) | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. | 3 hours, 24 hours and 14-21 days after treatment |
| 0 to 24 hours after treatment |
| Genetic Variants in Ivermectin/Albendazole Participants | In case of unexpected results for outcome measure 10 (Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)), whole genome sequencing will be performed on blood samples from participants in the ivermectin/albendazole arm to analyse genetic variation of relevance for ivermectin metabolism. | before treatment, i.e. at enrolment |
| Gut Bacterial Communities in Stool Samples | Taxonomic relative abundances of gut bacterial communities will be analysed with high-throughput sequencing. Absolute abundances of specific taxa will be measured using taxon-specific qPCR. Changes in relative and absolute abundances will be measured before and after treatment. | before treatment, i.e. at screening, and 14-21 days after treatment |
| Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0) | Blood type of participants will be collected during clinical examination prior treatment using blood type determination cards. | before treatment, i.e. at enrolment |
| Arm B: Albendazole |
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
| BG002 | Arm C: Ivermectin and Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole |
|
|
| Secondary | Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Posted | Geometric Mean | 95% Confidence Interval | percent change | 14-21 days after treatment |
|
|
|
| Secondary | Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | Posted | Number | 95% Confidence Interval | percentage of participants (%) | 14-21 days after treatment |
|
|
|
| Secondary | Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. | Posted | Mean | 95% Confidence Interval | percent change | 14-21 days after treatment |
|
|
|
| Secondary | Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | Available case analysis | Posted | Number | 95% Confidence Interval | percentage of participants (%) | 14-21 days after treatment |
|
|
|
| Secondary | Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. | Available case analysis | Posted | Mean | 95% Confidence Interval | percent change | 14-21 days after treatment |
|
|
|
| Secondary | Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | The CR will be calculated as the proportion of participants converting from being egg positive pre-treatment to egg negative post-treatment, multiplied by 100. | Available case analysis | Posted | Number | 95% Confidence Interval | percentage of participants (%) | 14-21 days after treatment |
|
|
|
| Secondary | Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the three treatment arms before and after treatment to assess the corresponding ERRs. | Available case analysis | Posted | Mean | 95% Confidence Interval | percent change | 14-21 days after treatment |
|
|
|
| Secondary | Number of Participants Reporting Adverse Events (AEs) | Participants will be monitored at the site for 3 hours following treatment for any acute AEs and reassessment will be done at 24h post-treatment. In addition, participants will be interviewed 3 and 24 hours after treatment and retrospectively at days 14-21 about the occurrence of AEs. | Analysis population at 3 hours after drug administration: N=255 Analysis population at 24 hours after drug administration: N=250 Analysis population at 14-21 days after drug administration: N=210 | Posted | Count of Participants | Participants | 3 hours, 24 hours and 14-21 days after treatment |
|
|
|
| Other Pre-specified | Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years) | For characterization of population pharmacokinetics (PK) and drug-drug interaction parameters ivermectin, albendazole and its metabolites 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 lower limit of quantification of 1-5 ng/ml. | Arm B did not receive ivermectin, thus no concentration was measured. | Posted | Median | Inter-Quartile Range | ng/ml | 0 to 24 hours after treatment |
|
|
|
| Other Pre-specified | Genetic Variants in Ivermectin/Albendazole Participants | In case of unexpected results for outcome measure 10 (Concentrations of Albendazole and Ivermectin/Albendazole Combination in Adolescents (Aged 12 to 20 Years)), whole genome sequencing will be performed on blood samples from participants in the ivermectin/albendazole arm to analyse genetic variation of relevance for ivermectin metabolism. | This analysis has not been performed. | Posted | before treatment, i.e. at enrolment |
|
|
| Other Pre-specified | Gut Bacterial Communities in Stool Samples | Taxonomic relative abundances of gut bacterial communities will be analysed with high-throughput sequencing. Absolute abundances of specific taxa will be measured using taxon-specific qPCR. Changes in relative and absolute abundances will be measured before and after treatment. | Not Posted | before treatment, i.e. at screening, and 14-21 days after treatment | Participants |
| Other Pre-specified | Exploratory Outcome: Number of Participants Within Each Blood Type Category (A, B, AB and 0) | Blood type of participants will be collected during clinical examination prior treatment using blood type determination cards. | Posted | Count of Participants | Participants | before treatment, i.e. at enrolment |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 31 |
| 85 |
| EG001 | Arm B: Albendazole | Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole | 0 | 84 | 0 | 84 | 26 | 84 |
| EG002 | Arm C: Ivermectin and Albendazole | Combination therapy of ivermectin (Stromectol®, 200 µg/kg using tablets of 3 mg) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0 Albendazole 400 mg Oral Tablet: Tablets of 400 mg albendazole Ivermectin 3 mg Oral Tablet: Tablets of 3 mg ivermectin | 0 | 86 | 0 | 86 | 34 | 86 |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Allergic reaction | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Symptoms related to immune system activation | Immune system disorders | CTCAE (5.0) | Non-systematic Assessment |
|
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| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017191 | Ascaridida Infections |
| D017190 | Secernentea Infections |
| D017206 | Strongylida Infections |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 3 hours: Abdominal pain |
|
|
| 3 hours: Nausea |
|
|
| 3 hours: Diarrhea |
|
|
| 3 hours: Itching |
|
|
| 3 hours: Symptoms related to immune system activation |
|
|
| 24 hours: Headache |
|
|
| 24 hours: Abdominal pain |
|
|
| 24 hours: Nausea |
|
|
| 24 hours: Diarrhea |
|
|
| 24 hours: Itching |
|
|
| 24 hours: Symptoms related to immune system activation |
|
|
| 14-21 days: Headache |
|
|
| 14-21 days: Abdominal pain |
|
|
| 14-21 days: Nausea |
|
|
| 14-21 days: Diarrhea |
|
|
| 14-21 days: Itching |
|
|
| 14-21 days: Symptoms related to immune system activation |
|
|
| cmax (ivermectin) [ng/ml] |
|
|
| Title | Measurements |
|---|---|
|
| Blood type B |
|
| Blood type AB |
|