Hookworm InfectionsPhase 2NCT05538767
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
A Phase 2 study testing Emodepside and Albendazole 400mg in people with Hookworm Infections, run by Jennifer Keiser at 1 site in Tanzania.
Trial summary
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hookworm Infections
- What is being tested?
- Emodepside and Albendazole 400mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteTanzania
- Study dates
- 16 Sep 2022to 11 Apr 2023
- 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 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male or female adults aged between 12 and 60 years;
- Written and signed informed consent;
- Was examined by a study physician before treatment;
- Provided two stool samples at baseline;
- Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one hookworm eggs.
Who cannot join
- Pregnant or lactating and/or planning to become pregnant within three months after drug treatment;
- Type 1 and/or 2 diabetes;
- Psychiatric disorders;
- History of ophthalmological conditions;
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment;
- Suffers from severe anaemia (Hb < 80 g/l);
Show all 11Show fewer
- Received anthelminthic treatment within past four weeks;
- Attending other clinical trials during the study;
- Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin;
- Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.
- Participated in stage I trials of this protocol
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Public Health Laboratory Ivo de Carneri
Chake Chake, Pemba, 122
About this study
Official title: Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
- Conditions
- Hookworm Infections
- Being tested
- Emodepside, Albendazole 400mg
- Keywords
- Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth
- 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.
EmodepsideDrug
Treatment with Emodepside 30 mg
Albendazole 400mgDrug
Treatment with Albendazole 400 mg
| Study group | Role | What they receive |
|---|---|---|
| Emodepside 30 mg | Experimental | Not described Receives: Drug: Emodepside |
| Albendazole 400 mg | Active comparator | Not described Receives: Drug: Albendazole 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate (CR) of emodepside against hookworm
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
Secondary outcomes (4)
Geometric Mean Egg Reduction Rate (ERR) of the emodepside 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: In the week between 14 and 21 days post-treatment
CR of emodepside against Trichuris trichiura and Ascaris lumbricoides
CR will be calculated as the percentage of Trichuris trichiura and Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.
Measured: In the week between 14 and 21 days post-treatment
ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.
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 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: In the week between 14 and 21 days post-treatment
Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.
Measured: At baseline and 14-21 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 posted14 Sep 2022
- Study start16 Sep 2022
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Keiser
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Responsible party
- Sponsor-investigator, Jennifer Keiser, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538767
- Sponsor's protocol ID
- EMODEPSIDE_PEMBA
- Status last verified
- Jun 2023
- First submitted
- 9 Sep 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X.
PubMed 39153818
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials
- ClinicalTrials.gov ID
- NCT05538767
- Acronym / sponsor ID
- EMODEPSIDE_PEMBA
- Conditions
- Hookworm Infections
- Keywords
- Hookworm, Emodepside, Efficacy, Safety, Confirmatory Stage, Soil Transmitted Helminth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Jennifer KeiserUniversity, hospital or other
- Collaborators
- Public Health Laboratory Ivo de Carneri
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 14 Sep 2022 (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.
To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emodepside 30 mg | Experimental | Drug: Emodepside |
| Albendazole 400 mg | Active comparator | Drug: Albendazole 400mg |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female adults aged between 12 and 60 years;
- Written and signed informed consent;
- Was examined by a study physician before treatment;
- Provided two stool samples at baseline;
- Hookworm EPG > 48 and at least two Kato-Katz thick smears slides with more than one hookworm eggs.
Key exclusion criteria (11 listed)
- Pregnant or lactating and/or planning to become pregnant within three months after drug treatment;
- Type 1 and/or 2 diabetes;
- Psychiatric disorders;
- History of ophthalmological conditions;
- Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment;
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 |
|---|---|---|
| EmodepsideTreatment with Emodepside 30 mg | Drug | Emodepside 30 mg |
| Albendazole 400mgTreatment with Albendazole 400 mg | Drug | Albendazole 400 mg |
Primary outcome
Cure rate (CR) of emodepside against hookworm
Time frame: In the week between 14 and 21 days post-treatment
CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.
4 secondary outcomes
Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.
Time frame: In the week between 14 and 21 days post-treatment
CR of emodepside against Trichuris trichiura and Ascaris lumbricoides
Time frame: In the week between 14 and 21 days post-treatment
ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.
Time frame: In the week between 14 and 21 days post-treatment
Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.
Time frame: At baseline and 14-21 days post-treatment
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 15 Jun 2023.
- Derived from this study: PubMed 39153818Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X.
- Individual participant dataSharing planned: Undecided
Related trials for Hookworm Infections
RecruitingPhase 3
Phase 3, Multi-center, Prospective, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Effectiveness and Safety of ZP5-9676 for the Treatment of Soil Transmitted Helminthiasis (STH)
Soil-Transmitted Helminthiasis (STH)
Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
RecruitingPhase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
Hookworm Infection
RecruitingPhase 4
Moxidectin Versus Ivermectin as Mass Drug Administration for the Control of Onchocerciasis and Other Neglected Tropical Diseases
Onchocerciasis, Ascaris Lumbricoides Infection
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 Emodepside and Albendazole 400mg in people with Hookworm Infections, run by Jennifer Keiser 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 11 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 15 Jun 2023. 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?
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 (CR) of emodepside against hookworm (time frame: In the week 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 NCT05538767, 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 15 Jun 2023.