Hookworm InfectionsPhase 2CHEW_MEB_PEMBANCT03995680
Efficacy and Safety of a New Chewable Versus the Swallowable Tablet of Mebendazole Against Hookworm
A Phase 2 study testing Mebendazole in people with Hookworm Infections, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookworm Infections
- What is being tested?
- Mebendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteTanzania
- Study dates
- 12 Jul 2019to 9 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female children aged between 3 and 12 years;
- Written informed consent signed by caregiver;
- Was examined by a study physician before treatment;
- Provided two stool samples at baseline;
- Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;
Who cannot join
- Pregnant;
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;
- Suffers from severe anemia (Hb < 80 g/l);
- Received anthelminthic treatment or metronidazole within past four weeks.
- Attending other clinical trials during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial
The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.
- Conditions
- Hookworm Infections
- Being tested
- Mebendazole
- Keywords
- Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Acceptability
- Medical subject headings
- Hookworm Infections, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MebendazoleDrug
Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
| Study group | Role | What they receive |
|---|---|---|
| Chewable tablet of mebendazole | Experimental | * 3-5 year olds allocated to the swallowable tablet arm will be given the crushed tablet on a spoon mixed with a small amount of clean water;
* 6-12 year olds allocated to the swallowable tablet arm will be given the whole tablet to swallow with a glass of clean water; Receives: Drug: Mebendazole |
| Swallowable tablet of mebendazole | Active comparator | * 3-5 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and swallow it without water; if they cannot chew it then a small amount of water will be added to the tablet in a spoon;
* 6-12 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and then swallow it without water. Receives: Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Secondary outcomes (8)
Cure Rate (CR) of Mebendazole Against Hookworm
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
CR of Both Mebendazole Regimens Against Trichuris Trichiura
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Geometric ERR of Both Mebendazole Formulations 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Geometric ERR of Both Mebendazole Formulations Against 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of the Two Formulations of Mebendazole Against 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of Both Mebendazole Formulations 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of Both Mebendazole Formulations Against 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100).
Measured: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start12 Jul 2019
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hookworm InfectionsStudies 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
- None (open label)
- Enrolment
- 397 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
- Investigators
- Jennifer Keiser, PhD, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995680
- Sponsor's protocol ID
- CHEW_MEB
- Acronym
- CHEW_MEB_PEMBA
- Status last verified
- Jul 2020
- First submitted
- 30 May 2019
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palmeirim MS, Bosch F, Ame SM, Ali SM, Hattendorf J, Keiser J. Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial. EClinicalMedicine. 2020 Sep 20;27:100556. doi: 10.1016/j.eclinm.2020.100556. eCollection 2020 Oct.
PubMed 33150325
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a New Chewable Tablet of Mebendazole Versus the Swallowable, Standard Tablet of Mebendazole Against Hookworm Infections in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03995680
- Acronym / sponsor ID
- CHEW_MEB_PEMBA / CHEW_MEB
- Conditions
- Hookworm Infections
- Keywords
- Mebendazole, Chewable tablet, Hookworm, Soil-transmitted helminths, Efficacy, Safety, Acceptability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 24 Jun 2019 (actual)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rational of this study is to provide evidence on the safety and efficacy of a new chewable tablet of mebendazole compared to the standard tablet in preschool- and school-aged children infected with hookworm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chewable tablet of mebendazole | Experimental | Drug: Mebendazole* 3-5 year olds allocated to the swallowable tablet arm will be given the crushed tablet on a spoon mixed with a small amount of clean water; * 6-12 year olds allocated to the swallowable tablet arm will be given the whole tablet to swallow with a glass of clean water; |
| Swallowable tablet of mebendazole | Active comparator | Drug: Mebendazole* 3-5 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and swallow it without water; if they cannot chew it then a small amount of water will be added to the tablet in a spoon; * 6-12 year olds allocated to the chewable tablet arm will be encouraged to chew the tablet and then swallow it without water. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female children aged between 3 and 12 years;
- Written informed consent signed by caregiver;
- Was examined by a study physician before treatment;
- Provided two stool samples at baseline;
- Hookworm EPG > 100 and at least two Kato-Katz thick smears slides with more than one hookworm egg;
Key exclusion criteria (5 listed)
- Pregnant;
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, such as can upon initial clinical assessment;
- Suffers from severe anemia (Hb < 80 g/l);
- Received anthelminthic treatment or metronidazole within past four weeks.
- Attending other clinical trials during the study.
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 |
|---|---|---|
| MebendazoleTreatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet. | Drug | Chewable tablet of mebendazole, Swallowable tablet of mebendazole |
Primary outcome
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100).
8 secondary outcomes
Cure Rate (CR) of Mebendazole Against Hookworm
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
CR of Both Mebendazole Regimens Against Trichuris Trichiura
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Geometric ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
CR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Geometric ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides.
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of the Two Formulations of Mebendazole Against Hookworm
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of Both Mebendazole Formulations Against Trichuris Trichiura
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Arithmetic ERR of Both Mebendazole Formulations Against Ascaris Lumbricoides
Time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33150325Palmeirim MS, Bosch F, Ame SM, Ali SM, Hattendorf J, Keiser J. Efficacy, safety and acceptability of a new chewable formulation versus the solid tablet of mebendazole against hookworm infections in children: An open-label, randomized controlled trial. EClinicalMedicine. 2020 Sep 20;27:100556. doi: 10.1016/j.eclinm.2020.100556. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
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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.
Jennifer Keiser, PhD principal investigator
Swiss Tropical & Public Health Institute
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 Mebendazole in people with Hookworm Infections, 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 5 inclusion and 5 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 20 Jul 2020. 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. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Geometric Mean Egg Reduction Rate (ERR) of the Two Formulations of Mebendazole Against Hookworm (time frame: Baseline (before treatment) and sometime between 14 and 21 days post-treatment). 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 NCT03995680, 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 20 Jul 2020.