AscariasisNCT00207753
Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections
A study testing albendazole vs. combined albendazole/ivermectin treatment in people with Ascariasis and Trichuriasis, run by Centers for Disease Control and Prevention at 1 site in Guatemala.
Trial summary
The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascariasis, Trichuriasis, Hookworm Infection
- What is being tested?
- albendazole vs. combined albendazole/ivermectin treatment
- How many people
- 550 participants
- Where
- 1 siteGuatemala
- Study dates
- Feb 2005to Mar 2005
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children will be eligible to participate in the study if they are between 5 and 12 years of age, are students in schools selected for study, and if parental consent and child assent for participation has been obtained.
Who cannot join
- those not fitting criteria above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren
The aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.
Read the detailed description
The aim of this study is to compare the efficacy and nutritional impact of two drug treatments against intestinal helminths from a rural area of Guatemala. The helminths that will be analyzed in this study are Ascaris lumbricoides, Trichuris trichiura, and hookworm. Because of the manifestations of these helminths infections, nutritional status can deteriorate in infected persons. According to the World Bank, these helminths are one of the top causes of childhood morbidity in many areas of the developing world (The World Bank, 1993).
This information will be gathered by collecting stool samples from schoolchildren, in order to determine the prevalence of infection in children living around Poptun, Guatemala. Height and weight measurements will also be taken, along with a visual exam of the skin for other parasitic skin infections. Children with an inadequate nutritional status are likely to be shorter in height and weigh less than children reared in an area with a low prevalence of helminths. After collecting this baseline information, we will split the children into two groups. One group will receive albendazole and the other group will receive albendazole/ivermectin. Both groups will be receiving is albendazole, the current standard of care treatment. Ivermectin is expected to improve efficacy and nutritional benefit as well as adding increased scope of treatment (Strongyloides, ectoparasites such as scabies and head lice). Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs is thought to be a more efficient use of the opportunity to access schoolchildren and provide health improvements. Providing data to support expanded treatment options will provide public health officials with the data needed to make such decisions.
- Conditions
- Ascariasis, Trichuriasis, Hookworm Infection, Strongyloidiasis, Pediculosis
- Being tested
- albendazole vs. combined albendazole/ivermectin treatment
- Keywords
- ascaris, trichuris, strongyloides, hookworm, head lice
- Medical subject headings
- Ascariasis, Trichuriasis, Hookworm Infections, Strongyloidiasis, Lice Infestations, Ancylostomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albendazole vs. combined albendazole/ivermectin treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy against geohelminths (stool egg count)
height increase
weight increase
Secondary outcomes (1)
ectoparasite examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AscariasisStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 550 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Universidad del Valle, Guatemala
- Investigators
- Michael J Beach, Ph.D., Principal investigator, Centers for Disease Control and PreventionByron Arana, MD, Principal investigator, MERTU/CDC-Universite de Valle de Guatemala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207753
- Sponsor's protocol ID
- CDC-NCID-4283
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 17 Nov 2005
- Results posted
- No
Publications
Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. doi: 10.1017/s0031182000006478.
PubMed 11386691Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. doi: 10.1017/s0031182000006491.
PubMed 11386688Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.
PubMed 11386686World Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Nutritional Assessment Following Albendazole and Combined Albendazole/Ivermectin Treatment for Intestinal Helminth Infections in Rural Guatemalan Schoolchildren
- ClinicalTrials.gov ID
- NCT00207753
- Acronym / sponsor ID
- CDC-NCID-4283
- Conditions
- Ascariasis, Trichuriasis, Hookworm Infection, Strongyloidiasis, Pediculosis
- Keywords
- ascaris, trichuris, strongyloides, hookworm, head lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Universidad del Valle, Guatemala
- Study start
- Feb 2005
- Study completion
- Mar 2005
- First posted
- 21 Sep 2005 (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 aim of this study is to compare the efficacy and impact on growth of two drug treatments against intestinal worms in schoolchildren from a rural area of Guatemala. According to the World Bank, these intestinal worms are one of the top causes of childhood health problems in many areas of the developing world (The World Bank, 1993). Infected children are more likely to have inadequate nutrition due to the worm infections and are more likely to be shorter in height and weigh less than children who are not infected. After collecting height and weight information, we will split the children into two groups. One group will receive albendazole and the other group will receive combined albendazole/ivermectin. Both groups will be receiving albendazole, the current standard of care treatment. Ivermection is expected to improve efficacy and nutritional benefit as well as add increased scope of treatment for the worm Strongyloides, and ectoparasites such as scabies and head lice. Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs would be a more efficient use of the opportunity to access schoolchildren and provide deworming treatment.
Detailed description
The aim of this study is to compare the efficacy and nutritional impact of two drug treatments against intestinal helminths from a rural area of Guatemala. The helminths that will be analyzed in this study are Ascaris lumbricoides, Trichuris trichiura, and hookworm. Because of the manifestations of these helminths infections, nutritional status can deteriorate in infected persons. According to the World Bank, these helminths are one of the top causes of childhood morbidity in many areas of the developing world (The World Bank, 1993).
This information will be gathered by collecting stool samples from schoolchildren, in order to determine the prevalence of infection in children living around Poptun, Guatemala. Height and weight measurements will also be taken, along with a visual exam of the skin for other parasitic skin infections. Children with an inadequate nutritional status are likely to be shorter in height and weigh less than children reared in an area with a low prevalence of helminths. After collecting this baseline information, we will split the children into two groups. One group will receive albendazole and the other group will receive albendazole/ivermectin. Both groups will be receiving is albendazole, the current standard of care treatment. Ivermectin is expected to improve efficacy and nutritional benefit as well as adding increased scope of treatment (Strongyloides, ectoparasites such as scabies and head lice). Both treatment regimens and the combination have been used millions of times in the developing world and are safe to use. Co-administration of drugs is thought to be a more efficient use of the opportunity to access schoolchildren and provide health improvements. Providing data to support expanded treatment options will provide public health officials with the data needed to make such decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children will be eligible to participate in the study if they are between 5 and 12 years of age, are students in schools selected for study, and if parental consent and child assent for participation has been obtained.
Key exclusion criteria (1 listed)
- those not fitting criteria above
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 vs. combined albendazole/ivermectin treatment | Drug | – |
Primary outcome
efficacy against geohelminths (stool egg count)
height increase
weight increase
1 secondary outcome
ectoparasite examination
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 17 Nov 2005.
- Background: PubMed 11386691Stephenson LS, Latham MC, Ottesen EA. Global malnutrition. Parasitology. 2000;121 Suppl:S5-22. doi: 10.1017/s0031182000006478.
- Background: PubMed 11386688Stephenson LS, Latham MC, Ottesen EA. Malnutrition and parasitic helminth infections. Parasitology. 2000;121 Suppl:S23-38. doi: 10.1017/s0031182000006491.
- Background: PubMed 11386686Horton J, Witt C, Ottesen EA, Lazdins JK, Addiss DG, Awadzi K, Beach MJ, Belizario VY, Dunyo SK, Espinel M, Gyapong JO, Hossain M, Ismail MM, Jayakody RL, Lammie PJ, Makunde W, Richard-Lenoble D, Selve B, Shenoy RK, Simonsen PE, Wamae CN, Weerasooriya MV. An analysis of the safety of the single dose, two drug regimens used in programmes to eliminate lymphatic filariasis. Parasitology. 2000;121 Suppl:S147-60. doi: 10.1017/s0031182000007423.
- BackgroundWorld Health Organization, 1992. Health of school children: treatment of intestinal helminths and schistosomiasis. Geneva: WHO.
Related trials for Ascariasis
Not yet recruitingPhase 3
Follow-up Assessment of Change in Soil-transmitted Helminths Infection Intensity in Uganda
Ascariasis
Not yet recruitingPhase 3
Combination Therapies for Trichuris Trichiura Infection in Schoolchildren in Honduras
Trichuriasis, Strongyloidiasis
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.
Michael J Beach, Ph.D. principal investigator
Centers for Disease Control and Prevention
Byron Arana, MD principal investigator
MERTU/CDC-Universite de Valle de Guatemala
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 vs. combined albendazole/ivermectin treatment in people with Ascariasis and Trichuriasis, run by Centers for Disease Control and Prevention at 1 site in Guatemala.
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 1 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 17 Nov 2005. 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 Guatemala. 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?
efficacy against geohelminths (stool egg count). 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 NCT00207753, which also lists 4 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 17 Nov 2005.