Soil-transmitted Helminth InfectionsStarwormsWP1NCT03465488
Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance
A study testing Albendazole Pill 400mg (GSK) in people with Soil-transmitted Helminth Infections, run by University Ghent at 4 sites in 4 countries.
Trial summary
Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Soil-transmitted Helminth Infections
- What is being tested?
- Albendazole Pill 400mg (GSK)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 15 Aug 2016to 1 Sep 2019
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject, male or female, is 5-14 years of age
- Subject is otherwise in an healthy condition (medical history and physical examination)
- Parent(s)/guardians of subjects (or their legally-accepted representatives) signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study.
- Subject of ≥6 years has assented (agreed) to participate in the study.
- Subject of ≥12 has signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- The subject swallowed the entire drug (ALB 400 mg) under supervision
- Subject provides a stool sample of at least 9 grams
Who cannot join
- Subject has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up
- Subject has any acute medical condition or is experiencing a severe concurrent medical condition
- Subject has a known hypersensitivity to benzimidazole drugs
- Subject has received an anthelminthic treatment within 90 of the start of the treatment.
- Subject vomited within 4 hours after drug administration
- Subject is unable to provide a stool sample at follow-up
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Brazil1 site
Fiocruz - Research institute of Renê Rachou
Belo Horizonte, Minas Gerais
Tanzania1 site
The Public Health Laboratory - Ivo de Carneri (PHL-IdC)
Chake Chake, Pemba
About this study
Official title: Validation of Both Automated Quality Assured Egg Counting System and Molecular Markers for Monitoring the Spread of Anthelmintic Resistance.
Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present.
This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem.
Read more
The specific objectives of the first work package are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance.
This study will be conducted at four different sites (Ethiopia, Tanzania, Lao PDR and Brazil) and will focus on school-aged children (age 5-14). At baseline subjects will be asked to provide a recent stool sample which will be processed using 3 different microscopic techniques (KK, Mini-Flotac and FECPAKG2). All children will be treated with a single-oral dose of albendazole (ALB) 400 mg and 14-21 days after treatment, a second stool sample will be collected from all children to again determine the fecal egg counts. At each sampling, stool is stored in preservative. Stored stool will be shipped to Belgium for DNA extraction and quantitative PCR (qPCR) analysis. A subset of the samples will be analysed by pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene. Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.
Read the detailed description
Background Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London Declaration on Neglected Tropical Diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. to illustrate, in the last four years the coverage of mass drug administration (MDA) has doubled from 30 to 60%, and ongoing global efforts are made to ultimately reach the milestone of 75% by 2020.
Threats While the laudable long-term aim is to eliminate STHs as a public health problem by 2020, and to eventually declare targeted geographical areas free from infections, this high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because the programs only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs.
Challenges
At present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. However, developing such a system is not straightforward. Deworming programs typically operate in resource-constrained settings, and program managers require some flexibility to minimize both financial and technical resources, while ensuring a reliable assessment of the drug efficacy. The most important obstacles to globally monitor patterns of changing drug efficacy and spread of anthelmintic resistance are the following:
- the shortage of diagnostic laboratories with experienced staff to perform the surveys and analyze and report the obtained data
- the absence of a quality assurance system that guarantees auditable results
- the lack of guidance in designing surveys as the programs progresses
- the lack of data supporting the validity of molecular markers to detect anthelmintic resistance in human STHs
- the lack of sensitive and point-of-care tools that allow the detection of low frequencies of anthelmintic resistance Main objective This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem by 2020.
The specific objectives of the first part of the project are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance.
Study protocol This study will conducted at four different sites at Africa (Ethiopia and Tanzania), Asia (Lao PDR) and Latin-America (Brazil). The selection of these sites is based on their experience in assessing drug efficacy and evaluating the performance of diagnostic tools, the availability of well-equipped diagnostic facilities and skilled personnel, and their national MDA history.
The study will focus on school-aged children (age of 5 to 14 years). At baseline subjects will be asked to provide a recent (within 4 hours) stool sample of at least 9 grams. All stool samples will be processed using the FECPAKG2, a duplicate Kato-Katz thick smear (the most commonly applied fecal egg count (FEC) technique) and Mini-Flotac (a novel technique that has a sensitivity at least equal to that of Kato-Katz). All children providing a stool sample will be provided a single-oral dose of ALB 400 mg under supervision. Fourteen to 21 days after treatment, a second stool sample will be collected from all the children that proved positive for any STH species at baseline to determine the FECs.
At each sampling, 2x 1 gram of stool is stored in preservative for downstream molecular analysis. Stored stool will be shipped to Belgium for DNA extraction and qPCR analysis. A subset of the samples will be analysed by Pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene.
Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.
Data handling Data will first be recorded on specific study record forms. These results will then be entered into the custom designed Excel-files by two different data entry clerks to minimize errors in data due to incorrect data entry.
Study management Studies in the different sites will be organized and supported out of Ghent University. The project team members will travel to each individual trial site to train local personnel in the different coprological techniques and to get them acquainted with the trial protocol and documents.
- Conditions
- Soil-transmitted Helminth Infections
- Being tested
- Albendazole Pill 400mg (GSK)
- Keywords
- parasitology, helminth infections, diagnosis, drug resistance, albendazole, benzimidazole drugs, Ascaris, Trichuris, hookworm, qPCR, microscopy
- Medical subject headings
- Trematode Infections, Disease, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albendazole Pill 400mg (GSK)Drug
Also called Albendazole 400mg form GlaxoSmithKline (Batch Nr: 335726)
One single dose of 400mg Albendazole is provided at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Experimental | All participants that meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study and receive a subject identifier (SubjectID). At baseline, all participants will receive a single treatment of albendazole 400mg and their stool will be examined for helminth eggs. Two to three weeks after treatment a follow-up examination of their stool is performed. Receives: Drug: Albendazole Pill 400mg (GSK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the performance of FECPAKG2 to assess drug efficacy
We will validate the performance of the FECPAKG2 as well as its ability to assess drug efficacy by means of egg reduction rates.
Measured: up to 12 months
In depth evaluation of the FECPAKG2 technique to assess drug efficacy
We will check the variation in egg counts obtained in repeated measurements and by different technicians and make a cost assessment.
Measured: up to 12 months
Validation of b-tubulin gene as a molecular marker for benzimidazole resistance
This will be done through assessment of the polymorphisms at the b-tubulin gene using a pyrosequencing approach. We will compare results obtained from the 4 different study sites which have a varying MDA history as well as results obtained from responders, poor responders and non-responders within each different site.
Measured: up to 24 months
Secondary outcomes (2)
Comparing the sensitivity of quantitative PCR with traditional diagnostic tools (Kato-Katz, Mini-FLOTAC and FECPAKG2) for the detection of soil-transmitted helminth infections.
It is commonly accepted that molecular tools are more sensitive to traditional diagnostic tools, however studies comparing qPCR with a wide range of traditional microscopic techniques are scarce. In this project we will evaluate the performance of qPCR in terms of sensitivity to detect infection compared to the results obtained by coprological analysis of samples by Kato-Katz, Mini-FLOTAC and FECPAKG2.
Measured: up to 12 months
Comparing the use of individual and pooled stool samples to assess polymorphisms in the β-tubulin gene.
Pyrosequencing results for β-tubulin gene from individual samples will be compared to those from pooled samples. This will shed a light on whether or not pooling stool samples provides similar information regarding the presence of single nucleotide polymorphisms as when compared to evaluating individual samples. This is important because pooling samples would allow important cuts in both technical and financial resources to process the samples.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Aug 2016
- Primary completion1 Jan 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Soil-transmitted Helminth 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Responsible party
- Principal investigator, Virologie, University Ghent
- Investigators
- Bruno Levecke, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465488
- Sponsor's protocol ID
- OPP1120972
- Acronym
- StarwormsWP1
- Status last verified
- Oct 2019
- First submitted
- 16 Feb 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified results will be shared online and with collaborating researchers for further extensive analysis.
Publications
Coffeng LE, Vlaminck J, Cools P, Denwood M, Albonico M, Ame SM, Ayana M, Dana D, Cringoli G, de Vlas SJ, Fenwick A, French M, Kazienga A, Keiser J, Knopp S, Leta G, Matoso LF, Maurelli MP, Montresor A, Mirams G, Mekonnen Z, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Steinmann P, Thomas E, Vercruysse J, Levecke B. A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study. PLoS Negl Trop Dis. 2023 May 17;17(5):e0011071. doi: 10.1371/journal.pntd.0011071. eCollection 2023 May.
PubMed 37196017Walker M, Cools P, Albonico M, Ame SM, Ayana M, Dana D, Keiser J, Matoso LF, Montresor A, Mekonnen Z, Correa-Oliveira R, Pinto SA, Sayasone S, Vercruysse J, Vlaminck J, Levecke B. Individual responses to a single oral dose of albendazole indicate reduced efficacy against soil-transmitted helminths in an area with high drug pressure. PLoS Negl Trop Dis. 2021 Oct 19;15(10):e0009888. doi: 10.1371/journal.pntd.0009888. eCollection 2021 Oct.
PubMed 34665810Vlaminck J, Cools P, Albonico M, Ame S, Ayana M, Cringoli G, Dana D, Keiser J, Maurelli MP, Matoso LF, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Thomas E, Vercruysse J, Verweij JJ, Levecke B. Therapeutic efficacy of albendazole against soil-transmitted helminthiasis in children measured by five diagnostic methods. PLoS Negl Trop Dis. 2019 Aug 1;13(8):e0007471. doi: 10.1371/journal.pntd.0007471. eCollection 2019 Aug.
PubMed 31369562Cools P, Vlaminck J, Albonico M, Ame S, Ayana M, Jose Antonio BP, Cringoli G, Dana D, Keiser J, Maurelli MP, Maya C, Matoso LF, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Thomas E, Verweij JJ, Vercruysse J, Levecke B. Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries. PLoS Negl Trop Dis. 2019 Aug 1;13(8):e0007446. doi: 10.1371/journal.pntd.0007446. eCollection 2019 Aug.
PubMed 31369558Vlaminck J, Cools P, Albonico M, Ame S, Ayana M, Bethony J, Cringoli G, Dana D, Keiser J, Maurelli MP, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Prichard R, Rashwan N, Rinaldi L, Sayasone S, Thomas E, Verweij JJ, Vercruysse J, Levecke B. Comprehensive evaluation of stool-based diagnostic methods and benzimidazole resistance markers to assess drug efficacy and detect the emergence of anthelmintic resistance: A Starworms study protocol. PLoS Negl Trop Dis. 2018 Nov 2;12(11):e0006912. doi: 10.1371/journal.pntd.0006912. eCollection 2018 Nov.
PubMed 30388108
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Both Automated Quality Assured Egg Counting System and Molecular Markers for Monitoring the Spread of Anthelmintic Resistance.
- ClinicalTrials.gov ID
- NCT03465488
- Acronym / sponsor ID
- StarwormsWP1 / OPP1120972
- Conditions
- Soil-transmitted Helminth Infections
- Keywords
- parasitology, helminth infections, diagnosis, drug resistance, albendazole, benzimidazole drugs, Ascaris, Trichuris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 14 Mar 2018 (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) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present.
This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem.
The specific objectives of the first work package are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance.
This study will be conducted at four different sites (Ethiopia, Tanzania, Lao PDR and Brazil) and will focus on school-aged children (age 5-14). At baseline subjects will be asked to provide a recent stool sample which will be processed using 3 different microscopic techniques (KK, Mini-Flotac and FECPAKG2). All children will be treated with a single-oral dose of albendazole (ALB) 400 mg and 14-21 days after treatment, a second stool sample will be collected from all children to again determine the fecal egg counts. At each sampling, stool is stored in preservative. Stored stool will be shipped to Belgium for DNA extraction and quantitative PCR (qPCR) analysis. A subset of the samples will be analysed by pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene. Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.
Detailed description
Background Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London Declaration on Neglected Tropical Diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. to illustrate, in the last four years the coverage of mass drug administration (MDA) has doubled from 30 to 60%, and ongoing global efforts are made to ultimately reach the milestone of 75% by 2020.
Threats While the laudable long-term aim is to eliminate STHs as a public health problem by 2020, and to eventually declare targeted geographical areas free from infections, this high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because the programs only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs.
Challenges
At present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. However, developing such a system is not straightforward. Deworming programs typically operate in resource-constrained settings, and program managers require some flexibility to minimize both financial and technical resources, while ensuring a reliable assessment of the drug efficacy. The most important obstacles to globally monitor patterns of changing drug efficacy and spread of anthelmintic resistance are the following:
- the shortage of diagnostic laboratories with experienced staff to perform the surveys and analyze and report the obtained data
- the absence of a quality assurance system that guarantees auditable results
- the lack of guidance in designing surveys as the programs progresses
- the lack of data supporting the validity of molecular markers to detect anthelmintic resistance in human STHs
- the lack of sensitive and point-of-care tools that allow the detection of low frequencies of anthelmintic resistance Main objective This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem by 2020.
The specific objectives of the first part of the project are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance.
Study protocol This study will conducted at four different sites at Africa (Ethiopia and Tanzania), Asia (Lao PDR) and Latin-America (Brazil). The selection of these sites is based on their experience in assessing drug efficacy and evaluating the performance of diagnostic tools, the availability of well-equipped diagnostic facilities and skilled personnel, and their national MDA history.
The study will focus on school-aged children (age of 5 to 14 years). At baseline subjects will be asked to provide a recent (within 4 hours) stool sample of at least 9 grams. All stool samples will be processed using the FECPAKG2, a duplicate Kato-Katz thick smear (the most commonly applied fecal egg count (FEC) technique) and Mini-Flotac (a novel technique that has a sensitivity at least equal to that of Kato-Katz). All children providing a stool sample will be provided a single-oral dose of ALB 400 mg under supervision. Fourteen to 21 days after treatment, a second stool sample will be collected from all the children that proved positive for any STH species at baseline to determine the FECs.
At each sampling, 2x 1 gram of stool is stored in preservative for downstream molecular analysis. Stored stool will be shipped to Belgium for DNA extraction and qPCR analysis. A subset of the samples will be analysed by Pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene.
Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.
Data handling Data will first be recorded on specific study record forms. These results will then be entered into the custom designed Excel-files by two different data entry clerks to minimize errors in data due to incorrect data entry.
Study management Studies in the different sites will be organized and supported out of Ghent University. The project team members will travel to each individual trial site to train local personnel in the different coprological techniques and to get them acquainted with the trial protocol and documents.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Drug: Albendazole Pill 400mg (GSK)All participants that meet all inclusion criteria and none of the exclusion criteria will be enrolled in the study and receive a subject identifier (SubjectID). At baseline, all participants will receive a single treatment of albendazole 400mg and their stool will be examined for helminth eggs. Two to three weeks after treatment a follow-up examination of their stool is performed. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Subject, male or female, is 5-14 years of age
- Subject is otherwise in an healthy condition (medical history and physical examination)
- Parent(s)/guardians of subjects (or their legally-accepted representatives) signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study.
- Subject of ≥6 years has assented (agreed) to participate in the study.
- Subject of ≥12 has signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Key exclusion criteria (6 listed)
- Subject has active diarrhea (defined as the passage of 3 or more loose or liquid stools per day) at baseline or follow-up
- Subject has any acute medical condition or is experiencing a severe concurrent medical condition
- Subject has a known hypersensitivity to benzimidazole drugs
- Subject has received an anthelminthic treatment within 90 of the start of the treatment.
- Subject vomited within 4 hours after drug administration
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 Pill 400mg (GSK)Also: Albendazole 400mg form GlaxoSmithKline (Batch Nr: 335726)One single dose of 400mg Albendazole is provided at baseline. | Drug | Subjects |
Primary outcome
Validation of the performance of FECPAKG2 to assess drug efficacy
Time frame: up to 12 months
We will validate the performance of the FECPAKG2 as well as its ability to assess drug efficacy by means of egg reduction rates.
In depth evaluation of the FECPAKG2 technique to assess drug efficacy
Time frame: up to 12 months
We will check the variation in egg counts obtained in repeated measurements and by different technicians and make a cost assessment.
Validation of b-tubulin gene as a molecular marker for benzimidazole resistance
Time frame: up to 24 months
This will be done through assessment of the polymorphisms at the b-tubulin gene using a pyrosequencing approach. We will compare results obtained from the 4 different study sites which have a varying MDA history as well as results obtained from responders, poor responders and non-responders within each different site.
2 secondary outcomes
Comparing the sensitivity of quantitative PCR with traditional diagnostic tools (Kato-Katz, Mini-FLOTAC and FECPAKG2) for the detection of soil-transmitted helminth infections.
Time frame: up to 12 months
Comparing the use of individual and pooled stool samples to assess polymorphisms in the β-tubulin gene.
Time frame: up to 24 months
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 21 Oct 2019.
- Derived from this study: PubMed 37196017Coffeng LE, Vlaminck J, Cools P, Denwood M, Albonico M, Ame SM, Ayana M, Dana D, Cringoli G, de Vlas SJ, Fenwick A, French M, Kazienga A, Keiser J, Knopp S, Leta G, Matoso LF, Maurelli MP, Montresor A, Mirams G, Mekonnen Z, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Steinmann P, Thomas E, Vercruysse J, Levecke B. A general framework to support cost-efficient fecal egg count methods and study design choices for large-scale STH deworming programs-monitoring of therapeutic drug efficacy as a case study. PLoS Negl Trop Dis. 2023 May 17;17(5):e0011071. doi: 10.1371/journal.pntd.0011071. eCollection 2023 May.
- Derived from this study: PubMed 34665810Walker M, Cools P, Albonico M, Ame SM, Ayana M, Dana D, Keiser J, Matoso LF, Montresor A, Mekonnen Z, Correa-Oliveira R, Pinto SA, Sayasone S, Vercruysse J, Vlaminck J, Levecke B. Individual responses to a single oral dose of albendazole indicate reduced efficacy against soil-transmitted helminths in an area with high drug pressure. PLoS Negl Trop Dis. 2021 Oct 19;15(10):e0009888. doi: 10.1371/journal.pntd.0009888. eCollection 2021 Oct.
- Derived from this study: PubMed 31369562Vlaminck J, Cools P, Albonico M, Ame S, Ayana M, Cringoli G, Dana D, Keiser J, Maurelli MP, Matoso LF, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Thomas E, Vercruysse J, Verweij JJ, Levecke B. Therapeutic efficacy of albendazole against soil-transmitted helminthiasis in children measured by five diagnostic methods. PLoS Negl Trop Dis. 2019 Aug 1;13(8):e0007471. doi: 10.1371/journal.pntd.0007471. eCollection 2019 Aug.
- Derived from this study: PubMed 31369558Cools P, Vlaminck J, Albonico M, Ame S, Ayana M, Jose Antonio BP, Cringoli G, Dana D, Keiser J, Maurelli MP, Maya C, Matoso LF, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Pinto SA, Rinaldi L, Sayasone S, Thomas E, Verweij JJ, Vercruysse J, Levecke B. Diagnostic performance of a single and duplicate Kato-Katz, Mini-FLOTAC, FECPAKG2 and qPCR for the detection and quantification of soil-transmitted helminths in three endemic countries. PLoS Negl Trop Dis. 2019 Aug 1;13(8):e0007446. doi: 10.1371/journal.pntd.0007446. eCollection 2019 Aug.
- Derived from this study: PubMed 30388108Vlaminck J, Cools P, Albonico M, Ame S, Ayana M, Bethony J, Cringoli G, Dana D, Keiser J, Maurelli MP, Montresor A, Mekonnen Z, Mirams G, Correa-Oliveira R, Prichard R, Rashwan N, Rinaldi L, Sayasone S, Thomas E, Verweij JJ, Vercruysse J, Levecke B. Comprehensive evaluation of stool-based diagnostic methods and benzimidazole resistance markers to assess drug efficacy and detect the emergence of anthelmintic resistance: A Starworms study protocol. PLoS Negl Trop Dis. 2018 Nov 2;12(11):e0006912. doi: 10.1371/journal.pntd.0006912. eCollection 2018 Nov.
- Project websiteLink provided by the sponsor.
- Laboratory websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified results will be shared online and with collaborating researchers for further extensive analysis.
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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.
Bruno Levecke, PhD principal investigator
University Ghent
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole Pill 400mg (GSK) in people with Soil-transmitted Helminth Infections, run by University Ghent at 4 sites in 4 countries.
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 7 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: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Brazil, Ethiopia, Laos, 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.
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?
Validation of the performance of FECPAKG2 to assess drug efficacy (time frame: up to 12 months). The study lists 3 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 NCT03465488, which also lists 5 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 21 Oct 2019.