Helminths InfectionPhase 4BenziRNCT04326868
Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
A Phase 4 study testing Benzimidazole Anthelmintic in people with Helminths Infection and Drug Resistance, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial summary
Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568… Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminths Infection, Drug Resistance
- What is being tested?
- Benzimidazole Anthelmintic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteGabon
- Study dates
- 11 Nov 2019to 30 Jan 2021
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Living in Lambaréné and surrounding areas
- Written informed consent or assent
- Microscopy positive for any major Soil-Transmitted helminths
Who cannot join
- Microscopy negative for any STH
- Pregnant women
- Do not be available for followed up.
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Centre de Recherches Médicales de Lammbaréné
Lambaréné, Moyen-Ogooué Province, 1437
About this study
Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) [albendazole (ABZ) and mebendazole (MBZ)] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.
Read the detailed description
A Randomized Controlled Clinical Trial (RCT) cohort study, to evaluate the efficacy and safety of three benzimidazole derivates drug (Albendazole, Mebendazole, Albendazole Mebendazole, and Albendazole-Pyrantel) to treat major STH in school aged children from Lambaréné and surroundings. After obtaining informed consent from parents or guardians, stool samples will be collected, for infectious status. If positive the participant will be treated with either drug combination. The efficacy and SNP frequencies will be assessed at weeks 3 and 6 post treatment
Description of study population Children of school and preschool age (2 to 17 years old) living in Lambaréné and the surrounding areas are eligible. The choice of school and preschool-aged children is based on the fact that they constitute the main population at risk of infection. In addition, most of the resources available for public health interventions in many endemic areas of soil-transmitted helminths target this group as a cost-effective method for reaching a large part of the population.
The previous analysis of patient cohort reported a success rate of 61% multispecies prevalence amongst children in the study area and considering a significance level of 95% confidence interval (α =5%) and a minimum power of 80%, the investigators will have to include a total of 255 participants in the study
- Conditions
- Helminths Infection, Drug Resistance
- Being tested
- Benzimidazole Anthelmintic
- Keywords
- Helminths, Resistance, Gabon, Infection, CERMEL, Benzimidazole
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzimidazole AnthelminticDrug
Also called Albendazole, Mebendazole, Pyrantel
The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
| Study group | Role | What they receive |
|---|---|---|
| Albendazole | Active comparator | ABZ (400mg) Receives: Drug: Benzimidazole Anthelmintic |
| Albendazole and Mebendazole | Experimental | ABZ 400mg + 1 tablet of MBZ (500mg) Receives: Drug: Benzimidazole Anthelmintic |
| Albendazole and Pyrantel | Experimental | ABZ (400mg) + Pyr (125 mg) Receives: Drug: Benzimidazole Anthelmintic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of eggs rate reduction .
The assessment of efficacy will be the level of the eggs rate reduction . The assessment will be done at weeks 3 and 6 and a different treatment regimen will be compared according to protocol and intention to treat.
This evaluation will be based on the same parasitological examinations carried out at the beginning. Using polymerase chain reaction(PCR) for a better, appreciation of the efficacy of Benzimidazole.
Measured: three weeks to six weeks
Assessment of cure rate
The assessment of efficacy as a cure rate, based on the absence of eggs at three and six weeks post treatment, using microscopy and PRC examination.
Measured: three weeks to six weeks
Secondary outcomes (1)
The assessment of safety
The adverse events due to a drug intake and the frequency of single nucleotide polymorphisms (SNPs) before and after treatment in each group.The safety of administration of Benzimidazole will be evaluated primarily clinically. The safety will be evaluated within 24 hours and at any unscheduled visit or at week 3 and week 6 to record any symptoms that occur after the drug has been administered.
Measured: three to six weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start11 Nov 2019
- Primary completion31 Dec 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helminths 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants diagnosed positive for Soil Helminths Infection will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study. These regimens consisted of treatment as follow: given as a single tablet once daily for 3 consecutive days * A single tablet of ABZ (400mg), administered during 3 consecutive days; * 1 tablet of ABZ 400mg + 1 tablet of MBZ (500mg) administered in 3 consecutive days, * 1 tablet of ABZ (400mg) + Pyr (125 mg) administered in 3 consecutive days
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayôla Akim ADEGNIKA, Principal investigator, Centre de Recherche Médicale de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326868
- Sponsor's protocol ID
- 0084/2019/PR/SG/CNER
- Other IDs
- CEI- 007/2019
- Acronym
- BenziR
- Status last verified
- Jul 2021
- First submitted
- 4 Mar 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Data will be shared in RedCap database.
Publications
Dejon Agobe JC, Nguema-Moure PA, Manouana GP, Laclong Lontchi RA, Nzamba Maloum M, Manfoumbi Mabicka DC, Chassem Lapue C, Edoa JR, Zinsou JF, Honkpehedji YJ, Adegbite BR, Ramharter M, Borrmann S, Kremsner PG, Adegnika AA. Molecular-based assessment of the efficacy of anthelminthic combination regimens for the treatment of Strongyloides stercoralis in Gabon. Parasitol Res. 2025 Dec 9;124(12):154. doi: 10.1007/s00436-025-08610-0.
PubMed 41364144Nguema Moure PA, Nzamba Maloum M, Manouana GP, Laclong Lontchi R-A, Mbong Ngwese M, Edoa JR, Frejus Zinsou J, Meulah B, Mahmoudou S, N'noh Dansou EM, Josiane Honkpehedji Y, Romeo Adegbite B, Agnandji ST, Ramharter M, Lell B, Borrmann S, Kremsner PG, Dejon-Agobe JC, Adegnika AA. A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambarene and surroundings. Antimicrob Agents Chemother. 2024 May 2;68(5):e0121123. doi: 10.1128/aac.01211-23. Epub 2024 Apr 2.
PubMed 38563751
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Soil Transmitted Helminths (STH) Resistance to Benzimidazole in School Aged Children Living in Gabon
- ClinicalTrials.gov ID
- NCT04326868
- Acronym / sponsor ID
- BenziR / 0084/2019/PR/SG/CNER
- Conditions
- Helminths Infection, Drug Resistance
- Keywords
- Helminths, Resistance, Gabon, Infection, CERMEL, Benzimidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 30 Mar 2020 (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.
Soil-transmitted helminths (STHs) infections are common in subtropics and mostly affect the poorest communities, with an impact on human health in many parts of the world. In 2017, World Health organization (WHO) reports more than 1.5 billion people are infected with soil-transmitted helminths worldwide, including 568 million school-age children who need treatment and preventive interventions. Preventive chemotherapy and periodic mass administration with benzimidazoles (BZ) [albendazole (ABZ) and mebendazole (MBZ)] are used to control these parasites. However, rapid reinfection with Ascaris lumbricoides within six months after a completed treatment has been reported, while the reinfection with hookworms is slow. Similarly, the efficacy of these drugs on Trichuris trichiura cure rate is poor. After many years of use of this drug class, there is an increase possibility that BZ resistance could develop. This resistance may occur due to single nucleotide polymorphisms (SNPs) in the β-tubulin gene at positions 167, 198 or 200, as has been reported in animals. Little data exist to show whether any of these polymorphisms do influence the BZ efficacy against STH in humans. The present study will develop methods to look for molecular evidence of BZ drug resistance in human population in order to support the investigation of the control and elimination of neglected tropical diseases (NTDs) in our communities.
Detailed description
A Randomized Controlled Clinical Trial (RCT) cohort study, to evaluate the efficacy and safety of three benzimidazole derivates drug (Albendazole, Mebendazole, Albendazole Mebendazole, and Albendazole-Pyrantel) to treat major STH in school aged children from Lambaréné and surroundings. After obtaining informed consent from parents or guardians, stool samples will be collected, for infectious status. If positive the participant will be treated with either drug combination. The efficacy and SNP frequencies will be assessed at weeks 3 and 6 post treatment
Description of study population Children of school and preschool age (2 to 17 years old) living in Lambaréné and the surrounding areas are eligible. The choice of school and preschool-aged children is based on the fact that they constitute the main population at risk of infection. In addition, most of the resources available for public health interventions in many endemic areas of soil-transmitted helminths target this group as a cost-effective method for reaching a large part of the population.
The previous analysis of patient cohort reported a success rate of 61% multispecies prevalence amongst children in the study area and considering a significance level of 95% confidence interval (α =5%) and a minimum power of 80%, the investigators will have to include a total of 255 participants in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- The participants diagnosed positive for Soil Helminths Infection will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study. These regimens consisted of treatment as follow: given as a single tablet once daily for 3 consecutive days * A single tablet of ABZ (400mg), administered during 3 consecutive days; * 1 tablet of ABZ 400mg + 1 tablet of MBZ (500mg) administered in 3 consecutive days, * 1 tablet of ABZ (400mg) + Pyr (125 mg) administered in 3 consecutive days
| Arm | Type | Receives |
|---|---|---|
| Albendazole | Active comparator | Drug: Benzimidazole AnthelminticABZ (400mg) |
| Albendazole and Mebendazole | Experimental | Drug: Benzimidazole AnthelminticABZ 400mg + 1 tablet of MBZ (500mg) |
| Albendazole and Pyrantel | Experimental | Drug: Benzimidazole AnthelminticABZ (400mg) + Pyr (125 mg) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Living in Lambaréné and surrounding areas
- Written informed consent or assent
- Microscopy positive for any major Soil-Transmitted helminths
Key exclusion criteria (3 listed)
- Microscopy negative for any STH
- Pregnant women
- Do not be available for followed up.
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 |
|---|---|---|
| Benzimidazole AnthelminticAlso: Albendazole, Mebendazole, PyrantelThe participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study. | Drug | Albendazole, Albendazole and Mebendazole, Albendazole and Pyrantel |
Primary outcome
Assessment of eggs rate reduction .
Time frame: three weeks to six weeks
The assessment of efficacy will be the level of the eggs rate reduction . The assessment will be done at weeks 3 and 6 and a different treatment regimen will be compared according to protocol and intention to treat. This evaluation will be based on the same parasitological examinations carried out at the beginning. Using polymerase chain reaction(PCR) for a better, appreciation of the efficacy of Benzimidazole.
Assessment of cure rate
Time frame: three weeks to six weeks
The assessment of efficacy as a cure rate, based on the absence of eggs at three and six weeks post treatment, using microscopy and PRC examination.
1 secondary outcome
The assessment of safety
Time frame: three to six 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 2 Aug 2021.
- Derived from this study: PubMed 41364144Dejon Agobe JC, Nguema-Moure PA, Manouana GP, Laclong Lontchi RA, Nzamba Maloum M, Manfoumbi Mabicka DC, Chassem Lapue C, Edoa JR, Zinsou JF, Honkpehedji YJ, Adegbite BR, Ramharter M, Borrmann S, Kremsner PG, Adegnika AA. Molecular-based assessment of the efficacy of anthelminthic combination regimens for the treatment of Strongyloides stercoralis in Gabon. Parasitol Res. 2025 Dec 9;124(12):154. doi: 10.1007/s00436-025-08610-0.
- Derived from this study: PubMed 38563751Nguema Moure PA, Nzamba Maloum M, Manouana GP, Laclong Lontchi R-A, Mbong Ngwese M, Edoa JR, Frejus Zinsou J, Meulah B, Mahmoudou S, N'noh Dansou EM, Josiane Honkpehedji Y, Romeo Adegbite B, Agnandji ST, Ramharter M, Lell B, Borrmann S, Kremsner PG, Dejon-Agobe JC, Adegnika AA. A randomized assessors-blind clinical trial to evaluate the safety and the efficacy of albendazole alone and in combination with mebendazole or pyrantel for the treatment of Trichuris trichiura infection in school-aged children in Lambarene and surroundings. Antimicrob Agents Chemother. 2024 May 2;68(5):e0121123. doi: 10.1128/aac.01211-23. Epub 2024 Apr 2.
- Individual participant dataSharing planned: Yes. The Data will be shared in RedCap database.
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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.
Ayôla Akim ADEGNIKA principal investigator
Centre de Recherche Médicale de Lambaréné
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 Benzimidazole Anthelmintic in people with Helminths Infection and Drug Resistance, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
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 3 inclusion and 3 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 2 Aug 2021. 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 Gabon. 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?
Assessment of eggs rate reduction . (time frame: three weeks to six weeks). The study lists 2 primary outcomes in all. 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 NCT04326868, which also lists 2 linked publications.
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 2 Aug 2021.