Trichuris Trichiura; InfectionPhase 2MOXIDOSENCT03501251
Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura
A Phase 2 study testing Moxidectin 8mg, Moxidectin 8 mg + albendazole 400 mg and Moxidectin 16 mg in people with Trichuris Trichiura; Infection, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania. Read more about this study
- Who is it for?
- Ages 16 to 18 years
- Conditions the study is for
- Trichuris Trichiura; Infection
- What is being tested?
- Moxidectin 8mg, Moxidectin 8 mg + albendazole 400 mg and Moxidectin 16 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 1 siteTanzania
- Study dates
- 3 Jul 2018to 11 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects aged 16 to 18 years, inclusive
- Written informed consent/assent signed from parent/guardian
- Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
Who cannot join
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
- Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
- Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
- Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
- Pregnant (urine testing) or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Public Health Laboratory Ivo de Carneri, P.O. Box 122
Chake Chake, Pemba
About this study
Official title: Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.
- Conditions
- Trichuris Trichiura; Infection
- Being tested
- Moxidectin 8mg, Moxidectin 8 mg + albendazole 400 mg, Moxidectin 16 mg, Moxidectin 16 mg + albendazole 400 mg, Moxidectin 24 mg
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidectin 8mgDrug
Participants will receive the tablet with clean water and a package of biscuits.
Moxidectin 8 mg + albendazole 400 mgDrug
Participants will receive the tablets with clean water and a package of biscuits.
Moxidectin 16 mgDrug
Participants will receive the tablets with clean water and a package of biscuits.
Moxidectin 16 mg + albendazole 400 mgDrug
Participants will receive the tablets with clean water and a package of biscuits.
Moxidectin 24 mgDrug
Participants will receive the tablets with clean water and a package of biscuits.
Moxidectin 24 mg + albendazole 400 mgDrug
Participants will receive the tablets with clean water and a package of biscuits.
PlaceboOther
Participants will receive the tablet with clean water and a package of biscuits.
| Study group | Role | What they receive |
|---|---|---|
| Moxidectin 8 mg | Experimental | A single tablet of 8 mg of moxidectin Receives: Drug: Moxidectin 8mg |
| Moxidectin 8 mg + Albendazole | Experimental | A single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg) Receives: Drug: Moxidectin 8 mg + albendazole 400 mg |
| Moxidectin 16 mg | Experimental | Two tablets of 8 mg of moxidectin ( = 16 mg) Receives: Drug: Moxidectin 16 mg |
| Moxidectin 16 mg + Albendazole | Experimental | Two tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg) Receives: Drug: Moxidectin 16 mg + albendazole 400 mg |
| Moxidectin 24 mg | Experimental | Three tablets of 8 mg of moxidectin ( = 24 mg) Receives: Drug: Moxidectin 24 mg |
| Moxidectin 24 mg + Albendazole | Experimental | Three tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg) Receives: Drug: Moxidectin 24 mg + albendazole 400 mg |
| Placebo | Placebo comparator | A single tablet of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate against Trichuris trichiura
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
Measured: 6 weeks
Secondary outcomes (6)
Egg Reduction Rate of the different drug regimens against Trichuris 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.
Measured: 6 weeks
Cure rate of the different drug regimens against Ascaris lumbricoides
Conversion from being Ascaris lumbricoides-egg positive pre-treatment to egg negative post-treatment.
Measured: 6 weeks
Egg Reduction Rate of Ascaris lumbricoides
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.
Measured: 6 weeks
Cure rate against hookworm
Conversion from being hookworm-egg positive pre-treatment to egg negative post-treatment.
Measured: 6 weeks
Egg Reduction Rate of hookworm
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.
Measured: 6 weeks
Number of adverse events at 5 time points
Patients will be kept for observation for at least 3 hours following treatment for any acute adverse events. During the reporting period, any unfavorable changes in the subject's condition will be recorded as adverse events, whether reported by the subject or observed by the Investigator. In case of any abnormal finding, the local study physician will perform a full clinical examination and findings will be recorded. An emergency kit will be available on site to treat any medical conditions that warrant urgent medical intervention. In addition, patients will be also interviewed by a nurse and/or a physician about the occurrence of adverse events 24, 48 and 72 hours post-treatment using a questionnaire. Finally, upon collection of the first follow-up stool sample participants will be re-questioned.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start3 Jul 2018
- Primary completion11 Aug 2018
- Study completion11 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trichuris Trichiura; InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Principal investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501251
- Sponsor's protocol ID
- MOXI_DOSE_PEMBA
- Acronym
- MOXIDOSE
- Status last verified
- Aug 2018
- First submitted
- 1 Mar 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020 Mar 3;70(6):1193-1201. doi: 10.1093/cid/ciz326.
PubMed 31044235
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris Trichiura in Adolescents: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03501251
- Acronym / sponsor ID
- MOXIDOSE / MOXI_DOSE_PEMBA
- Conditions
- Trichuris Trichiura; Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 11 Aug 2018 (actual)
- Study completion
- 11 Aug 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study rationale is to provide evidence on effective doses of moxidectin and/or moxidectin-albendazole in adolescents (16-18 years old) infected with Trichuris trichiura. The study will take place on Pemba Island, Tanzania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Moxidectin 8 mg | Experimental | Drug: Moxidectin 8mgA single tablet of 8 mg of moxidectin |
| Moxidectin 8 mg + Albendazole | Experimental | Drug: Moxidectin 8 mg + albendazole 400 mgA single tablet of 8 mg of moxidectin plus a single tablet of albendazole (400 mg) |
| Moxidectin 16 mg | Experimental | Drug: Moxidectin 16 mgTwo tablets of 8 mg of moxidectin ( = 16 mg) |
| Moxidectin 16 mg + Albendazole | Experimental | Drug: Moxidectin 16 mg + albendazole 400 mgTwo tablets of 8 mg of moxidectin ( = 16 mg) plus a single tablet of albendazole (400 mg) |
| Moxidectin 24 mg | Experimental | Drug: Moxidectin 24 mgThree tablets of 8 mg of moxidectin ( = 24 mg) |
| Moxidectin 24 mg + Albendazole | Experimental | Drug: Moxidectin 24 mg + albendazole 400 mgThree tablets of 8 mg of moxidectin ( = 24 mg) plus a single tablet of albendazole (400 mg) |
| Placebo | Placebo comparator | Other: PlaceboA single tablet of placebo |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male and female subjects aged 16 to 18 years, inclusive
- Written informed consent/assent signed from parent/guardian
- Positive for T. trichiura by at least two slides of the quadruple Kato-Katz thick smears and infection intensities of at least 100 eggs per gram of stool (EPG)
- Agree to comply with study procedures, including provision of two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
Key exclusion criteria (6 listed)
- Presence of acute or uncontrolled systemic illnesses (e.g. severe anemia, infection, clinical malaria) as assessed by a medical doctor, upon initial clinical assessment.
- Known or reported history of chronic illness such as HIV, acute or chronic hepatitis, cancer, diabetes, chronic heart disease or renal disease.
- Prior treatment with anthelmintics (eg, diethylcarbamazine [DEC], suramin, ivermectin or albendazole) within 4 weeks before planned test article administration.
- Received any investigational drugs or investigational devices within 4 weeks before administration of test article that may confound safety and/or efficacy assessments.
- Known or suspected allergy to moxidectin, ivermectin or albendazole or other compounds related to these classes of medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxidectin 8mgParticipants will receive the tablet with clean water and a package of biscuits. | Drug | Moxidectin 8 mg |
| Moxidectin 8 mg + albendazole 400 mgParticipants will receive the tablets with clean water and a package of biscuits. | Drug | Moxidectin 8 mg + Albendazole |
| Moxidectin 16 mgParticipants will receive the tablets with clean water and a package of biscuits. | Drug | Moxidectin 16 mg |
| Moxidectin 16 mg + albendazole 400 mgParticipants will receive the tablets with clean water and a package of biscuits. | Drug | Moxidectin 16 mg + Albendazole |
| Moxidectin 24 mgParticipants will receive the tablets with clean water and a package of biscuits. | Drug | Moxidectin 24 mg |
| Moxidectin 24 mg + albendazole 400 mgParticipants will receive the tablets with clean water and a package of biscuits. | Drug | Moxidectin 24 mg + Albendazole |
| PlaceboParticipants will receive the tablet with clean water and a package of biscuits. | Other | Placebo |
Primary outcome
Cure rate against Trichuris trichiura
Time frame: 6 weeks
Conversion from being Trichuris trichiura-egg positive pre-treatment to egg negative post-treatment. Since this might be influenced by infection intensity, treatment groups will be equally balanced in terms of infection intensity by 2 levels of baseline infection intensity (light infections and moderate/heavy infections).
6 secondary outcomes
Egg Reduction Rate of the different drug regimens against Trichuris trichiura
Time frame: 6 weeks
Cure rate of the different drug regimens against Ascaris lumbricoides
Time frame: 6 weeks
Egg Reduction Rate of Ascaris lumbricoides
Time frame: 6 weeks
Cure rate against hookworm
Time frame: 6 weeks
Egg Reduction Rate of hookworm
Time frame: 6 weeks
Number of adverse events at 5 time points
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 31044235Keller L, Palmeirim MS, Ame SM, Ali SM, Puchkov M, Huwyler J, Hattendorf J, Keiser J. Efficacy and Safety of Ascending Dosages of Moxidectin and Moxidectin-albendazole Against Trichuris trichiura in Adolescents: A Randomized Controlled Trial. Clin Infect Dis. 2020 Mar 3;70(6):1193-1201. doi: 10.1093/cid/ciz326.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxidectin 8mg, Moxidectin 8 mg + albendazole 400 mg and Moxidectin 16 mg in people with Trichuris Trichiura; Infection, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate against Trichuris trichiura (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03501251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.