Intestinal HelminthiasisNCT01658774
Impact of Repeated Anthelmintic Treatment on the Risk of Malaria in Kenyan School Children
A study testing Albendazole and Vitamin C in people with Intestinal Helminthiasis and Ascariasis, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial summary
Many school children in Kenya are infected with plasmodia and helminth species and are at risk of coinfection. It has been suggested that the immune response evoked by helminth infections may modify immune responses to plasmodia species and consequently alter infection and disease risks. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Helminthiasis, Ascariasis, Hookworm
- What is being tested?
- Albendazole and Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,377 participants
- Where
- 1 siteKenya
- Study dates
- Jan 2013to Jan 2015
- 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
- Pupils enrolled at participating schools in classes 1-7.
- Provision of informed consent from parent or legal guardian.
- Provision of assent by student.
- Detectable infection with A.lumbricoides, T. trichiura and/or hookworm species.
Who cannot join
- Pupils unwilling to participate in the study.
- Pupils who are infected with S. haematobium or S. mansoni. These children will be treated with praziquantel.
- Known or suspected sickle-cell trait.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya
Many school children in Kenya are infected with plasmodia and helminth species and are at risk of coinfection. It has been suggested that the immune response evoked by helminth infections may modify immune responses to plasmodia species and consequently alter infection and disease risks. However, studies conducted to date have been typically cross-sectional and produced conflicting results, and there is a need for longitudinal studies to better understand the clinical consequences for individuals harbouring coinfection. This study aims to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus annual treatment on the risk of clinical malaria and on immune responses among school children aged 5-14 years in Western Province. Specifically, this study aims to investigate the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in school children, assessed using active case detection; (ii) the prevalence and density of Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and helminth specific immune responses. The study hypothesis is that intensive anthelminthic treatment among children infected with either Ascaris lumbricoides or hookworm modifies human host immune responses to plasmodia and helminth infections, and therefore alters the risk of Plasmodium infection and clinical disease.
This individually randomised trial will recruit 1,450 children aged 5-14 years found to be infected with either Ascaris lumbricoides or hookworm species. Recruited children will be randomized to receive albendazole treatment either every three months or annually and monitored through periodic surveillance for clinical malaria episodes over 18 months. In addition, blood samples will be collected from sub-sample of children and screened for malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.
Read the detailed description
This will be an individual randomized, single-blind trial to evaluate the impact of intensive versus annual anthelminthic treatment on the incidence of clinical malaria in healthy school children.
The target population includes children attending primary school in western Kenya. The accessible population includes children attending the participating primary schools in standards 1-7 in western Kenya. The unit of analysis is the individual child. Children with informed consent and assent will be screened for helminth infections and those children found to be infected with either Ascaris lumbricoides or hookworm species will be recruited into the study. These children will be randomized to one or two groups, receiving either albendazole treatment every three months or albendazole at the start of the study and placebo every three months thereafter. Cross-sectional health surveys will be conducted before the intervention and at 6, 12 and 18 months follow-up. Weekly active case detection during school visits will be undertaken.
- Conditions
- Intestinal Helminthiasis, Ascariasis, Hookworm, Malaria
- Being tested
- Albendazole, Vitamin C
- Medical subject headings
- Intestinal helminthiasis, Ascariasis, Ancylostomiasis, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
Also called Zentel
Single 400mg dose
Vitamin CDietary supplement
500 mg Vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Albendazole & Vitamin C | Active comparator | Anthelmintics. A single dose of Albendazole (400mg) at month 0 and single dose of Vitamin C (500 mg) at 3, 6, 9 and 12 months. Receives: Drug: Albendazole; Dietary Supplement: Vitamin C |
| Albendazole | Experimental | Anthelmintics. A single does of Albendazole (400mg) every three months for 12 months Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical malaria
Incidence of clinical malaria, defined as fever (axillary temperature > 37.5 °C) or a reported history of fever within the preceding 24 hours in conjunction with a slide positive for Plasmodium spp. parasites at any density during 18 months of follow-up.
Measured: 18 months
Secondary outcomes (3)
Prevalence and density of Plasmodium spp. infection.
Measured: 18 months
Antibody isotype response to Plasmodium antigens.
ELISA analysis will be carried out to determine IgG1and IgG3 antibody response to Plasmodium antigens (schizont extract and Merozoite Surface Proteins (MSP)
Measured: 18 months
Antibody isotype response to helminth antigens.
ELISA analysis will be carried out to determine and IgE, IgG2, IgG4 and IgM responses to hookworm and Ascaris lumbricoides.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
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 Intestinal HelminthiasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,377 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Simon J Brooker, DPhil, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01658774
- Sponsor's protocol ID
- 2242
- Other IDs
- 241642
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2012
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kepha S, Nuwaha F, Nikolay B, Gichuki P, Mwandawiro CS, Mwinzi PN, Odiere MR, Edwards T, Allen E, Brooker SJ. Effect of Repeated Anthelminthic Treatment on Malaria in School Children in Kenya: A Randomized, Open-Label, Equivalence Trial. J Infect Dis. 2016 Jan 15;213(2):266-75. doi: 10.1093/infdis/jiv382. Epub 2015 Jul 13.
PubMed 26170395
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Repeated Anthelminthic Treatment on Malaria in School Children: an Individual Randomized, Double-blind, Placebo-controlled Trial in Western Kenya
- ClinicalTrials.gov ID
- NCT01658774
- Acronym / sponsor ID
- 2242
- Conditions
- Intestinal Helminthiasis, Ascariasis, Hookworm, Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,377 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- European Union, Wellcome Trust
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Aug 2012 (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.
Many school children in Kenya are infected with plasmodia and helminth species and are at risk of coinfection. It has been suggested that the immune response evoked by helminth infections may modify immune responses to plasmodia species and consequently alter infection and disease risks. However, studies conducted to date have been typically cross-sectional and produced conflicting results, and there is a need for longitudinal studies to better understand the clinical consequences for individuals harbouring coinfection. This study aims to investigate the impact of intensive (once every 3 months) anthelminthic treatment versus annual treatment on the risk of clinical malaria and on immune responses among school children aged 5-14 years in Western Province. Specifically, this study aims to investigate the impact of intensive anthelminthic treatment on (i) the incidence of clinical malaria in school children, assessed using active case detection; (ii) the prevalence and density of Plasmodium spp. infection, using repeat cross-sectional surveys; and (iii) malaria and helminth specific immune responses. The study hypothesis is that intensive anthelminthic treatment among children infected with either Ascaris lumbricoides or hookworm modifies human host immune responses to plasmodia and helminth infections, and therefore alters the risk of Plasmodium infection and clinical disease.
This individually randomised trial will recruit 1,450 children aged 5-14 years found to be infected with either Ascaris lumbricoides or hookworm species. Recruited children will be randomized to receive albendazole treatment either every three months or annually and monitored through periodic surveillance for clinical malaria episodes over 18 months. In addition, blood samples will be collected from sub-sample of children and screened for malaria specific immunoglobulin (Ig)G1 and IgG3 and helminth specific IgE, IgG2, IgG4 and IgM. Cell culture supernatants will be assayed for interferon (IFN)-γ, tumor necrosis factor (TNF)-α, interleukin (IL)-10, IL-5, IL-4 and IL-2.
Detailed description
This will be an individual randomized, single-blind trial to evaluate the impact of intensive versus annual anthelminthic treatment on the incidence of clinical malaria in healthy school children.
The target population includes children attending primary school in western Kenya. The accessible population includes children attending the participating primary schools in standards 1-7 in western Kenya. The unit of analysis is the individual child. Children with informed consent and assent will be screened for helminth infections and those children found to be infected with either Ascaris lumbricoides or hookworm species will be recruited into the study. These children will be randomized to one or two groups, receiving either albendazole treatment every three months or albendazole at the start of the study and placebo every three months thereafter. Cross-sectional health surveys will be conducted before the intervention and at 6, 12 and 18 months follow-up. Weekly active case detection during school visits will be undertaken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albendazole & Vitamin C | Active comparator | Drug: Albendazole, Dietary Supplement: Vitamin CAnthelmintics. A single dose of Albendazole (400mg) at month 0 and single dose of Vitamin C (500 mg) at 3, 6, 9 and 12 months. |
| Albendazole | Experimental | Drug: AlbendazoleAnthelmintics. A single does of Albendazole (400mg) every three months for 12 months |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pupils enrolled at participating schools in classes 1-7.
- Provision of informed consent from parent or legal guardian.
- Provision of assent by student.
- Detectable infection with A.lumbricoides, T. trichiura and/or hookworm species.
Key exclusion criteria (3 listed)
- Pupils unwilling to participate in the study.
- Pupils who are infected with S. haematobium or S. mansoni. These children will be treated with praziquantel.
- Known or suspected sickle-cell trait.
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 |
|---|---|---|
| AlbendazoleAlso: ZentelSingle 400mg dose | Drug | Albendazole, Albendazole & Vitamin C |
| Vitamin C500 mg Vitamin C | Dietary supplement | Albendazole & Vitamin C |
Primary outcome
Incidence of clinical malaria
Time frame: 18 months
Incidence of clinical malaria, defined as fever (axillary temperature > 37.5 °C) or a reported history of fever within the preceding 24 hours in conjunction with a slide positive for Plasmodium spp. parasites at any density during 18 months of follow-up.
3 secondary outcomes
Prevalence and density of Plasmodium spp. infection.
Time frame: 18 months
Antibody isotype response to Plasmodium antigens.
Time frame: 18 months
Antibody isotype response to helminth antigens.
Time frame: 18 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 10 Apr 2015.
- Derived from this study: PubMed 26170395Kepha S, Nuwaha F, Nikolay B, Gichuki P, Mwandawiro CS, Mwinzi PN, Odiere MR, Edwards T, Allen E, Brooker SJ. Effect of Repeated Anthelminthic Treatment on Malaria in School Children in Kenya: A Randomized, Open-Label, Equivalence Trial. J Infect Dis. 2016 Jan 15;213(2):266-75. doi: 10.1093/infdis/jiv382. Epub 2015 Jul 13.
- Training Health Researchers into Vocational Excellence in East AfricaLink provided by the sponsor.
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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.
Simon J Brooker, DPhil principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole and Vitamin C in people with Intestinal Helminthiasis and Ascariasis, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
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 4 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 10 Apr 2015. 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 Kenya. 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?
Incidence of clinical malaria (time frame: 18 months). 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 NCT01658774, 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 10 Apr 2015.