Infection by Trichuris TrichiuraPhase 4NCT01327469
The Efficacy of Five Anthelmintic Regimes Against Trichuris Trichiura Infections in Schoolchildren in Jimma, Ethiopia
A Phase 4 study testing Albendazole, 2 x 400mg, Albendazole 400mg and Mebendazole 500mg in people with Infection by Trichuris Trichiura, run by University Ghent at 1 site in Ethiopia.
Trial summary
The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection by Trichuris Trichiura
- What is being tested?
- Albendazole, 2 x 400mg, Albendazole 400mg and Mebendazole 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,250 participants
- Where
- 1 siteEthiopia
- Study dates
- Dec 2010to Mar 2011
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- all school age children who are eligible to participate in the study
Who cannot join
- Not willing to participate (no informed consent)
- Unable to give samples for follow up
- Severe intercurrent medical condition
- Diarrhea at first sampling
- Study subjects who had treatment for STH in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
The major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH and more than one billion individuals are thought to be infected, of which 450 million have significant morbidity attributable from their infection, school-aged children in particular. In this population infections cause stunting of the linear growth, anemia, reduce the cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are highly prevalent, affecting more than 60% of the children (data not published).
Current efforts to control STH infections involve periodic mass drug anthelmintic treatment of infected children in endemic areas and are likely to intensify as more attention is addressed to the importance of these neglected diseases. Monitoring drug efficacy in these control programs has become indispensable in order to detect the emergence of resistance and/or identify confounding factors affecting the drug efficacy. Recently a study has evaluated a single dose albendazole (ALB) in school age children across 7 countries, including Ethiopia, revealing that this regime is highly efficacious for the treatment of A. lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate. Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose 10mg/kg), of which the latter holds promise as it can also be administrated to children between 6 months and 2 years. The main objective of the present study, therefore, is to assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x 500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).
- Conditions
- Infection by Trichuris Trichiura
- Being tested
- Albendazole, 2 x 400mg, Albendazole 400mg, Mebendazole 500mg, Mebendazole 2 x 500mg, Pyrantel-oxantel + mebendazole
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole, 2 x 400mgDrug
Albendazole 2 x 400mg
Albendazole 400mgDrug
Albendazole 400mg
Mebendazole 500mgDrug
Mebendazole 500mg
Mebendazole 2 x 500mgDrug
Mebendazole 2 x 500mg
Pyrantel-oxantel + mebendazoleDrug
Pyrantel-oxantel + mebendazole
| Study group | Role | What they receive |
|---|---|---|
| Albendazole 400mg | Experimental | albendazole, 1 x 400mg Receives: Drug: Albendazole 400mg |
| Albendazole 2 x 400mg | Experimental | albendazole, 2 x 400mg Receives: Drug: Albendazole, 2 x 400mg |
| Mebendazole 500mg | Experimental | mebendazole, 1 x 500mg Receives: Drug: Mebendazole 500mg |
| Mebendazole 2 x 500mg | Experimental | mebendazole, 2x 500mg Receives: Drug: Mebendazole 2 x 500mg |
| Pyrantel-oxantel + mebendazole | Experimental | pyrantel-oxantel (10mg/kg)+ mebendazole (500mg) Receives: Drug: Pyrantel-oxantel + mebendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy against T. trichiura of various treatment regimes
The evaluation of the efficacy against T. trichiura of various treatment regimes. To this end, subjects infected with T. trichura (based on McMaster), will be randomly assigned to one of the five proposed treatment regimes. Two weeks after the treatment, faecal egg counts will be performed and the reduction in faecal egg counts will be evaluated
Measured: After two weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionFeb 2011
- Study completionMar 2011
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 Infection by Trichuris TrichiuraStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- VLIR-UOS Institutional University Cooperation
- Investigators
- Jozef Vercruysse, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327469
- Sponsor's protocol ID
- 2010/517
- Status last verified
- Mar 2011
- First submitted
- 30 Mar 2011
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.
PubMed 22189084
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 5 Anthelmintic Regimes Against T. Trichiura Infections in Schoolchildren in Jimma, Ethiopia
- ClinicalTrials.gov ID
- NCT01327469
- Acronym / sponsor ID
- 2010/517
- Conditions
- Infection by Trichuris Trichiura
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,250 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- VLIR-UOS Institutional University Cooperation
- Study start
- Dec 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Apr 2011 (estimated)
- 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 major soil-transmitted helminths (STHs), Ascaris lumbricoides (roundworm), Trichuris trichiura (whipworm) and Necator americanus/Ancylostoma duodenal (hookworms) are amongst the most prevalent parasites worldwide. An estimated 4.5 billion individuals are at risk for STH and more than one billion individuals are thought to be infected, of which 450 million have significant morbidity attributable from their infection, school-aged children in particular. In this population infections cause stunting of the linear growth, anemia, reduce the cognitive function and contribute to the existing malnutrition. In Jimma (Ethiopia), STH are highly prevalent, affecting more than 60% of the children (data not published).
Current efforts to control STH infections involve periodic mass drug anthelmintic treatment of infected children in endemic areas and are likely to intensify as more attention is addressed to the importance of these neglected diseases. Monitoring drug efficacy in these control programs has become indispensable in order to detect the emergence of resistance and/or identify confounding factors affecting the drug efficacy. Recently a study has evaluated a single dose albendazole (ALB) in school age children across 7 countries, including Ethiopia, revealing that this regime is highly efficacious for the treatment of A. lumbricoides (99.5%) and hookworms (94.8%), but not for T. trichiura (50.8%). For this parasite a repeated dose regime of ALB on consecutive days is likely to be more appropriate. Alternative drugs are mebendazole (single dose 500mg) and pyrantel+oxantel (single dose 10mg/kg), of which the latter holds promise as it can also be administrated to children between 6 months and 2 years. The main objective of the present study, therefore, is to assess the efficacy of 5 different treatment regimes against T. trichiura in schoolchildren in Jimma, Ethiopia, including albendazole (1 x 400mg, 2 x 400mg), mebendazole (1 x 500mg, 2x 500mg) and pyrantel-oxantel (10mg/kg)+mebendazole (500mg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Albendazole 400mg | Experimental | Drug: Albendazole 400mgalbendazole, 1 x 400mg |
| Albendazole 2 x 400mg | Experimental | Drug: Albendazole, 2 x 400mgalbendazole, 2 x 400mg |
| Mebendazole 500mg | Experimental | Drug: Mebendazole 500mgmebendazole, 1 x 500mg |
| Mebendazole 2 x 500mg | Experimental | Drug: Mebendazole 2 x 500mgmebendazole, 2x 500mg |
| Pyrantel-oxantel + mebendazole | Experimental | Drug: Pyrantel-oxantel + mebendazolepyrantel-oxantel (10mg/kg)+ mebendazole (500mg) |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all school age children who are eligible to participate in the study
Key exclusion criteria (5 listed)
- Not willing to participate (no informed consent)
- Unable to give samples for follow up
- Severe intercurrent medical condition
- Diarrhea at first sampling
- Study subjects who had treatment for STH in the last 3 months
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 |
|---|---|---|
| Albendazole, 2 x 400mgAlbendazole 2 x 400mg | Drug | Albendazole 2 x 400mg |
| Albendazole 400mgAlbendazole 400mg | Drug | Albendazole 400mg |
| Mebendazole 500mgMebendazole 500mg | Drug | Mebendazole 500mg |
| Mebendazole 2 x 500mgMebendazole 2 x 500mg | Drug | Mebendazole 2 x 500mg |
| Pyrantel-oxantel + mebendazolePyrantel-oxantel + mebendazole | Drug | Pyrantel-oxantel + mebendazole |
Primary outcome
Efficacy against T. trichiura of various treatment regimes
Time frame: After two weeks treatment
The evaluation of the efficacy against T. trichiura of various treatment regimes. To this end, subjects infected with T. trichura (based on McMaster), will be randomly assigned to one of the five proposed treatment regimes. Two weeks after the treatment, faecal egg counts will be performed and the reduction in faecal egg counts will be evaluated
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 1 Apr 2011.
- Derived from this study: PubMed 22189084Levecke B, Mekonnen Z, Albonico M, Vercruysse J. The impact of baseline faecal egg counts on the efficacy of single-dose albendazole against Trichuris trichiura. Trans R Soc Trop Med Hyg. 2012 Feb;106(2):128-30. doi: 10.1016/j.trstmh.2011.09.007. Epub 2011 Dec 19.
Related trials for Infection by Trichuris Trichiura
Not yet recruitingPhase 3
Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections
Trichuris Trichiura; Infection, Hookworm Infection
RecruitingPhase 2
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Trichuriasis
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
RecruitingPhase 1
Controlled Human Infection Study of Orally Administered Trichuris Trichiura Eggs in Naïve Adults
Whipworm, Trichuriasis
Active, not recruiting
Cement flooRs AnD chiLd hEalth (CRADLE)
Ascaris Lumbricoides Infection, Necator Americanus 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.
Jozef Vercruysse, PhD principal investigator
University Ghent
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 Albendazole, 2 x 400mg, Albendazole 400mg and Mebendazole 500mg in people with Infection by Trichuris Trichiura, run by University Ghent at 1 site in Ethiopia.
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 1 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 1 Apr 2011. 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 Ethiopia. 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 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?
Efficacy against T. trichiura of various treatment regimes (time frame: After two weeks 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 NCT01327469, 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 1 Apr 2011.