Hookworm InfectionsPhase 4NCT03261596
Mebendazole Study Against Hookworm Infections in Children and Adolescents in Ghana
A Phase 4 study testing Mebendazole in people with Hookworm Infections, run by PATH at 1 site in Ghana.
Trial summary
The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hookworm Infections
- What is being tested?
- Mebendazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGhana
- Study dates
- Sep 2017to Dec 2017
- Phase
- Phase 4
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All participants must meet all of the following inclusion criteria:
- Male or female, aged 6 to 18 years, inclusive, at the time of randomization.
- Written informed consent signed by at least one parent and/or legally acceptable representative (as defined by local law); and assent by participant.
- Able and willing to be examined by a study health care provider at the beginning of the study.
- Able and willing to provide one stool sample at the beginning (baseline) and one sample approximately three weeks after treatment (follow-up).
- Positive for hookworm eggs in the stool (two Kato-Katz thick smear slides with more than one hookworm egg) at baseline.
Who cannot join
- Participants must meet none of the following exclusion criteria to be eligible for this study:
- Presence of major systemic illnesses as assessed by a study health care provider, upon initial targeted clinical assessment.
- Pregnancy, based on a positive urine rapid test, or breastfeeding in girls after menarche.
- Recent use of an anthelminthic drug (within the past 4 weeks) or use of anthelminthics not provided by study staff during the study period.
- Known allergy to mebendazole or albendazole.
- Participation in other clinical trials during the study.
Trial locations and contacts
1 site in 1 country.
Ghana1 site
Noguchi Memorial Institute for Medical Research - University of Ghana
Legon, Accra
About this study
Official title: Efficacy and Safety of a Single-dose Regimen and a Multi-dose Regimen of Mebendazole Against Hookworm Infections in Children and Adolescents in Ghana: a Randomized Controlled Trial
The Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine.
Read the detailed description
This study will determine the Cure Rates (CRs) of mebendazole regimens to be used as comparator drug regimens in the future pivotal trial of tribendimidine and will provide evidence of the efficacy and safety of mebendazole among children and adolescents infected with hookworm in Ghana. Children and adolescents bear a large burden of morbidity from hookworm infection, so building the evidence base for effective treatments in this population has important public health implications in Ghana and other endemic settings.
- Conditions
- Hookworm Infections
- Being tested
- Mebendazole
- Keywords
- Soil-transmitted helminth, hookworm, hookworm infections, necator americanus, ancylostoma duodenale
- 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
Also called Vermox
Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.
| Study group | Role | What they receive |
|---|---|---|
| 100 mg solid tablets 2x/day for 3 days | Experimental | Assess the efficacy (Cure Rate/CR) and safety of 100 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm. Receives: Drug: Mebendazole |
| Single dose 500 mg solid tablets | Experimental | Assess the efficacy (Cure Rate/CR) and safety of 500 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm. Receives: Drug: Mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate (CR) against hookworm, as determined by Kato Katz.
To determine point estimates for the efficacy of two mebendazole regimens: (i) 100 mg solid tablets twice daily for three days, and (ii) single dose of 500 mg solid tablets in participants aged 6 to 18 years infected with hookworm. The CR will be calculated as the percentage of children and adolescents (all hookworm egg-positive at enrollment) who are egg negative 20 days after treatment. The CRs will be tabulated by mebendazole dose regimen received, along with their corresponding 95% CIs.
Measured: 20 days
Secondary outcomes (3)
Egg reduction rate (ERR), based on geometric mean, against hookworm
In a simple analysis, the study will estimate a risk ratio between CRs by using log binomial regression. Baseline characteristics will be assessed by arm to determine any imbalance between the two randomization arms. Any factor (e.g., age, sex, school, weight, height, baseline hookworm infection intensity) out of balance at baseline will be adjusted for in the analyses. Sensitivity analyses will be conducted which will consider all participants with missing endpoint data as treatment failure or all as treatment success to test whether the results (of the CR comparison) are sensitive to potential differences in loss to follow-up.
Measured: 20 days
CR and ERR against Ascaris lumbricoides and Trichuris trichiura
Determine the ERR in the two treatment arms; EPG will be assessed by adding up the egg counts from the Kato-Katz thick smears and multiplying this number by twenty-four. The ERR will be calculated (ERR = (1-(mean egg count at follow-up/mean egg count at baseline))*100). Geometric mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. The bootstrap resampling method with 5,000 replicates will be used to calculate 95% CIs for ERRs and the difference between the ERRs. Analyses of mebendazole efficacy against concomitant STHs will proceed similarly to those conducted for hookworm.
Measured: 20 days
Adverse Events
For the safety objective, the probability of observing zero, one or more, and two or more solicited AEs among the 150 subjects in each treatment arm given a true event rate. For example, if the true rate of an AE among subjects receiving single dose mebendazole is 1% then the probability we will see 1 or more subjects with this event is 78%.
Measured: Through 20 days of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: In light of new evidence, the decision was made by the sponsor to not proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a single site Phase 4, open-label, randomized controlled study. Subjects will be randomized 1:1 to one of two treatment allocations: 150 to receive a single dose of 500 mg mebendazole and 150 to receive a multi-dose of 100 mg mebendazole twice a day for three days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Noguchi Memorial Institute for Medical Research, Ghana Health Services, HopeXchange Medical Center, Ghana, Kintampo Health Research Centre, Ghana
- Responsible party
- Sponsor
- Investigators
- Michael Cappello, MD, Principal investigator, Yale UniversityMichael Wilson, PhD, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261596
- Sponsor's protocol ID
- STH-MBZ-PO-4 02-GHA
- Status last verified
- Nov 2017
- First submitted
- 16 Aug 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The final results of this study will be published in a scientific journal and presented at scientific conferences. Any publication, lecture, and manuscripts of the findings of this study by any individual involved with the study will be governed by the procedure outlined in the Clinical Trial Agreement. Within any presentation or publication, confidentiality of individual subjects will be maintained, with identification by subject code number and initials, if applicable. A summary of study conclusions will be shared with the local community.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Single-dose Regimen and a Multi-dose Regimen of Mebendazole Against Hookworm Infections in Children and Adolescents in Ghana: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03261596
- Acronym / sponsor ID
- STH-MBZ-PO-4 02-GHA
- Conditions
- Hookworm Infections
- Keywords
- Soil-transmitted helminth, hookworm, hookworm infections, necator americanus, ancylostoma duodenale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In light of new evidence, the decision was made by the sponsor to not proceed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Yale University, Noguchi Memorial Institute for Medical Research, Ghana Health Services, HopeXchange Medical Center, Ghana, Kintampo Health Research Centre, Ghana
- Study start
- Sep 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Aug 2017 (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 Ghana study will hypothesize that both the multiple dose and single dose of mebendazole will achieve effective cure rates against hookworm among children and adolescents. This study is intended to be a pilot study for a planned Phase 3 registration trial of a new drug for hookworm, tribendimidine.
Detailed description
This study will determine the Cure Rates (CRs) of mebendazole regimens to be used as comparator drug regimens in the future pivotal trial of tribendimidine and will provide evidence of the efficacy and safety of mebendazole among children and adolescents infected with hookworm in Ghana. Children and adolescents bear a large burden of morbidity from hookworm infection, so building the evidence base for effective treatments in this population has important public health implications in Ghana and other endemic settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be a single site Phase 4, open-label, randomized controlled study. Subjects will be randomized 1:1 to one of two treatment allocations: 150 to receive a single dose of 500 mg mebendazole and 150 to receive a multi-dose of 100 mg mebendazole twice a day for three days.
| Arm | Type | Receives |
|---|---|---|
| 100 mg solid tablets 2x/day for 3 days | Experimental | Drug: MebendazoleAssess the efficacy (Cure Rate/CR) and safety of 100 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm. |
| Single dose 500 mg solid tablets | Experimental | Drug: MebendazoleAssess the efficacy (Cure Rate/CR) and safety of 500 mg dose regimen of mebendazole in children aged 6 to 18 years, inclusive, infected with hookworm. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Male or female, aged 6 to 18 years, inclusive, at the time of randomization.
- Written informed consent signed by at least one parent and/or legally acceptable representative (as defined by local law); and assent by participant.
- Able and willing to be examined by a study health care provider at the beginning of the study.
- Able and willing to provide one stool sample at the beginning (baseline) and one sample approximately three weeks after treatment (follow-up).
- Positive for hookworm eggs in the stool (two Kato-Katz thick smear slides with more than one hookworm egg) at baseline.
Key exclusion criteria (6 listed)
- Participants must meet none of the following exclusion criteria to be eligible for this study:
- Presence of major systemic illnesses as assessed by a study health care provider, upon initial targeted clinical assessment.
- Pregnancy, based on a positive urine rapid test, or breastfeeding in girls after menarche.
- Recent use of an anthelminthic drug (within the past 4 weeks) or use of anthelminthics not provided by study staff during the study period.
- Known allergy to mebendazole or albendazole.
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 |
|---|---|---|
| MebendazoleAlso: VermoxParticipants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code. | Drug | 100 mg solid tablets 2x/day for 3 days, Single dose 500 mg solid tablets |
Primary outcome
Cure Rate (CR) against hookworm, as determined by Kato Katz.
Time frame: 20 days
To determine point estimates for the efficacy of two mebendazole regimens: (i) 100 mg solid tablets twice daily for three days, and (ii) single dose of 500 mg solid tablets in participants aged 6 to 18 years infected with hookworm. The CR will be calculated as the percentage of children and adolescents (all hookworm egg-positive at enrollment) who are egg negative 20 days after treatment. The CRs will be tabulated by mebendazole dose regimen received, along with their corresponding 95% CIs.
3 secondary outcomes
Egg reduction rate (ERR), based on geometric mean, against hookworm
Time frame: 20 days
CR and ERR against Ascaris lumbricoides and Trichuris trichiura
Time frame: 20 days
Adverse Events
Time frame: Through 20 days of follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: Undecided. The final results of this study will be published in a scientific journal and presented at scientific conferences. Any publication, lecture, and manuscripts of the findings of this study by any individual involved with the study will be governed by the procedure outlined in the Clinical Trial Agreement. Within any presentation or publication, confidentiality of individual subjects will be maintained, with identification by subject code number and initials, if applicable. A summary of study conclusions will be shared with the local community.
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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.
Michael Cappello, MD principal investigator
Yale University
Michael Wilson, PhD principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mebendazole in people with Hookworm Infections, run by PATH at 1 site in Ghana.
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 6 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: withdrawn, as of the sponsor's last update on 17 Nov 2017. 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 Ghana. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 (CR) against hookworm, as determined by Kato Katz. (time frame: 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.