A Phase 3 interventional study of Moxidectin 2 mg Oral Tablet and Albendazole 400 mg Oral Tablet in Trichuriasis, Ascariasis and Hookworm Infections, sponsored by Jennifer Keiser. Completed at 1 site in Côte D'Ivoire. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Jennifer Keiser · Phase 3, Interventional, and Treatment
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.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 255 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Jennifer Keiser is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Moxidectin 2 mg Oral Tablet · Drug: Albendazole 400 mg Oral Tablet
Placebo (for moxidectin, 4 tablets) and albendazole (Zentel®, 1 tablet of 400 mg) administered orally at day 0
Drug: Albendazole 400 mg Oral Tablet
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
Drug: Albendazole 400 mg Oral Tablet · Drug: Ivermectin 3 mg Oral Tablet
Tablets of 2 mg moxidectin
Tablets of 400 mg albendazole
Also known as: Zentel®
Tablets of 3 mg ivermectin
Also known as: Stromectol®
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.
Time frame: 14-21 days after treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours, 24 hours and 14-21 days after treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: before treatment, i.e. at enrolment
| Milestone | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Started | 85 | 84 | 86 |
| Completed | 72 | 67 | 71 |
| Not completed | 13 | 17 | 15 |
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.
| percentage of participants (%) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole |
|---|---|---|
| Cure Rate (CR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 15.3 (7.9 to 25.7) | 13.4 (6.3 to 24.0) |
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.
| percent change | Arm A: Moxidectin and Albendazole | Arm B: Albendazole |
|---|---|---|
| Egg Reduction Rate (ERR) of Moxidectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 67.0 (47.8 to 80.1) | 60.2 (35.7 to 76.5) |
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.
| percentage of participants (%) | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|
| Cure Rate (CR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 13.4 (6.3 to 24.0) | 22.5 (13.5 to 34.0) |
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.
| percent change | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|
| Egg Reduction Rate (ERR) of Ivermectin/Albendazole Combination Therapy Compared to Albendazole Monotherapy Against T. Trichiura | 60.2 (35.7 to 76.5) | 81.5 (68.8 to 89.1) |
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.
| percentage of participants (%) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Cure Rates (CRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 95.5 (86.0 to 100) | 95.5 (86.0 to 100) | 100 (100 to 100) |
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.
| percent change | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Egg Reduction Rates (ERRs) of the Study Drugs Against Ascaris Lumbricoides Infections in Co-infected Participants | 100 (100 to 100) | 100 (100 to 100) | 100 (100 to 100) |
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.
| percentage of participants (%) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Cure Rates (CRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 100 (100 to 100) | 37.5 (0 to 80.8) | 20.0 (0 to 75.5) |
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.
| percent change | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Egg Reduction Rates (ERRs) of the Study Drugs Against Hookworm Infections in Co-infected Participants | 100 (100 to 100) | 95.7 (78.5 to 99.3) | 90.7 (78.6 to 97.7) |
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.
| Participants | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| 3 hours: Headache | 1 | 5 | 7 |
| 3 hours: Abdominal pain | 4 | 6 | 8 |
| 3 hours: Nausea | 3 | 2 | 2 |
| 3 hours: Diarrhea | 2 | 1 | 1 |
| 3 hours: Itching | 1 | 6 | 2 |
| 3 hours: Symptoms related to immune system activation | 3 | 5 | 5 |
| 24 hours: Headache | 4 | 9 | 6 |
| 24 hours: Abdominal pain | 8 | 5 | 12 |
| 24 hours: Nausea | 1 | 0 | 3 |
| 24 hours: Diarrhea | 5 | 4 | 7 |
| 24 hours: Itching | 9 | 8 | 4 |
| 24 hours: Symptoms related to immune system activation | 1 | 5 | 3 |
| 14-21 days: Headache | 0 | 0 | 0 |
| 14-21 days: Abdominal pain | 0 | 0 | 0 |
| 14-21 days: Nausea | 0 | 0 | 0 |
| 14-21 days: Diarrhea | 0 | 0 | 0 |
| 14-21 days: Itching | 0 | 0 | 0 |
| 14-21 days: Symptoms related to immune system activation | 0 | 0 | 0 |
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.
| ng/ml | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|
| cmax (albendazole) [ng/ml] | 26.5 (20.0 to 36.8) | 26.5 (20.0 to 36.8) |
| cmax (ivermectin) [ng/ml] | — | 40.1 (32.4 to 59.1) |
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.
No measurements were reported for this outcome.
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.
Results for this outcome have not been posted.
Blood type of participants will be collected during clinical examination prior treatment using blood type determination cards.
| Participants | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Blood type 0 | 48 | 47 | 47 |
| Blood type A | 20 | 18 | 12 |
| Blood type B | 15 | 16 | 24 |
| Blood type AB | 2 | 3 | 3 |
Collected over 14-21 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Moxidectin and Albendazole | 0/85 (0%) | 0/85 (0%) | 31/85 (36.5%) |
| Arm B: Albendazole | 0/84 (0%) | 0/84 (0%) | 26/84 (31%) |
| Arm C: Ivermectin and Albendazole | 0/86 (0%) | 0/86 (0%) | 34/86 (39.5%) |
| Event | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole |
|---|---|---|---|
| Abdominal painGastrointestinal disorders | 11/85 | 10/84 | 18/86 |
| HeadacheGeneral disorders | 4/85 | 12/84 | 12/86 |
| ItchingSkin and subcutaneous tissue disorders | 9/85 | 11/84 | 5/86 |
| Symptoms related to immune system activationImmune system disorders | 4/85 | 10/84 | 8/86 |
| DiarrheaGastrointestinal disorders | 6/85 | 4/84 | 7/86 |
| NauseaGeneral disorders | 4/85 | 2/84 | 5/86 |
| Allergic reactionGeneral disorders | 2/85 | 0/84 | 2/86 |
| Age, Categorical(Participants) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|
| <=18 years | 38 | 39 | 33 | 110 |
| Between 18 and 65 years | 47 | 45 | 53 | 145 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|
| Mean | 30.1 ± 16.1 | 26.7 ± 14.5 | 29.9 ± 15.4 | 28.9 ± 15.4 |
| Sex: Female, Male(Participants) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|
| Female | 44 | 44 | 49 | 137 |
| Male | 41 | 40 | 37 | 118 |
| Race and Ethnicity Not Collected(Participants) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(Participants) | Arm A: Moxidectin and Albendazole | Arm B: Albendazole | Arm C: Ivermectin and Albendazole | Total |
|---|---|---|---|---|
| Côte D'Ivoire | 85 | 84 | 86 | 255 |
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Studies of the drugs tested here: Moxidectin · Ivermectin
Jennifer Keiser