MalariaPhase 4ACTIPTNCT01459146
Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana
A Phase 4 study testing Artemether-lumefantrine combination plus albendazole, Artemether-lumefantrine plus Praziquantel plus Albendazole and Albendazole plus Praziquantel in people with Malaria and Schistosomiasis, run by Navrongo Health Research Centre, Ghana at 1 site in Ghana.
Trial summary
The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Malaria, Schistosomiasis, Helminthiasis
- What is being tested?
- Artemether-lumefantrine combination plus albendazole, Artemether-lumefantrine plus Praziquantel plus Albendazole and Albendazole plus Praziquantel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteGhana
- Study dates
- Dec 2010to Nov 2012
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental informed consent and assent by schoolchildren
- No known history of allergy to any study drug
- Aged 6 or more years
Who cannot join
- lack of parental informed consent and assent by schoolchildren
- Known allergy or history of allergy to any study drug
- Aged less than 6 years
Trial locations and contacts
1 site in 1 country.
Ghana1 site, 1 recruiting
- Recruiting
NHRC
Navrongo
Ernest C Opoku, MD, MPH, +233 244 734608, erniecudjoe@yahoo.com
Abraham V Hodgson, MD, MPH, PhD, +233 244 577665, AHodgson@navrongo.mimcom.net
About this study
Official title: The Impact of Intermittent Preventive Malaria Treatment With Artemisinin Combination Therapy (ACT) on Hemoglobin, Malaria, Schistosomiasis, and School Attention Among Primary Schoolchildren in the Kassena-Nankana Districts, Ghana
The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration.
Read the detailed description
Introduction: Malaria, schistosomiasis and soil-transmitted helminth (STH) infections are rife in sub-Saharan Africa where school children are at great risk of morbidity. Although the strategy of using intermittent preventive treatment (IPT) for malaria control has been proven beneficial among infants and pregnant women, it is yet to be implemented in school children on a large scale. Sulfadoxine-pyrimethamine (SP) use as IPT is being limited by widespread reports of resistance. Artemisinin-based combination therapy (ACT) has been proven efficacious as IPT among school children in few studies. Other studies have shown that artemisinin derivatives exhibit anti-schistosomal activity. This could be an added effect of using ACTs, as IPT, to prevent malaria related morbidity in school children in sub-Saharan Africa.
General Objective: To examine the effect of IPT with ACTs and anti-helminthes against malaria and helminthes infections on health and school attention among children 6 to 12 years old.
Specific objectives
- To estimate the prevalence of malaria parasitemia, schistosomiasis and anemia among primary schoolchildren.
- To determine the impact of 3 doses of IPT (with artemether-lumefantrine) and de-worming (with albendazole and/or praziquantel) on hemoglobin and school (classroom) attention and recall.
- To determine the effects of IPT (with artemether-lumefantrine) and de-worming (with albendazole and /or praziquantel) on the prevalence and intensity of schistosomes infection among schoolchildren.
- To determine the safety and tolerability of IPT with artemether-lumefantrine combined with albendazole and/or praziquantel among school children.
Materials and methods: An open-labeled randomized trial, including 3 arms, will be carried out in 6 primary schools in the Kassena-Nankana Districts, Ghana, where malaria and schistosome infection (with S. hematobium and S. mansoni) are endemic. After informed consent and assent are obtained, about 345 (115 in each arm) class three school children will be investigated for malaria parasitemia, anemia, schistosome and soil-transmitted helminths infections, and classroom attention and recall in a baseline pre-intervention survey. Mass treatment is then carried out in the 6 randomized schools with ACT and albendazole in one study arm; ACT, albendazole and praziquantel in the second arm while albendazole and praziquantel will be given in the third school arm. ACT mass treatment using artemether-lumefantrine is carried out every school term (4 monthly) for one year while praziquantel is given once and albendazole twice a year. After one academic year, the same 345 (115 in each arm) selected participants in class three are assessed for hemoglobin, malaria parasitemia, STH and schistosome infections and classroom attention and recall. Safety and tolerability of the combined IPT is assessed at 28 days post treatment.
Data analysis- Data will be analyzed by both intention-to-treat and per-protocol employing uni-variate and multivariate logistic regression analysis.
- Conditions
- Malaria, Schistosomiasis, Helminthiasis, Anemia, Change in Sustained Attention
- Being tested
- Artemether-lumefantrine combination plus albendazole, Artemether-lumefantrine plus Praziquantel plus Albendazole, Albendazole plus Praziquantel
- Keywords
- IPT, malaria, ACT, schistosomiasis, Hemoglobin, Anemia, Sustained attention, Recall, Schoolchildren, Kassena-Nankana
- Medical subject headings
- Malaria, Schistosomiasis, Helminthiasis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combination plus albendazoleDrug
AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
Artemether-lumefantrine plus Praziquantel plus AlbendazoleDrug
Artemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral
Albendazole plus PraziquantelDrug
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
| Study group | Role | What they receive |
|---|---|---|
| AL plus ABZ; Arm 1 | Experimental | Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral Receives: Drug: Artemether-lumefantrine combination plus albendazole |
| AL plus PZQ plus ABZ; Arm 2 | Active comparator | artemether-lumefantrine combination 120mg/20mg 12 hourly for 3 days; plus praziquantel 40mg/kg stat; plus albendazole 400mg stat oral Receives: Drug: Artemether-lumefantrine plus Praziquantel plus Albendazole |
| ABZ plus PZQ; Arm 3 | Active comparator | Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral Receives: Drug: Albendazole plus Praziquantel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy
Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions
Measured: Day 28 post intervention
Secondary outcomes (6)
Number of participants with adverse events as a measure of safety and tolerability
Number of reported adverse events within twelve months of intervention per study arm
Measured: Day 365
Number of schoolchildren with sustained attention and recall as a measure of efficacy
Change in sustained classroom attention and recall in 365 days of start of intervention from baseline
Measured: Day 365
Proportion of schoolchildren with anemia as a measure of safety and tolerability
Proportion of schoolchildren having hemoglobin level less than 12.0g/dl from baseline level in 365 days of start of intervention
Measured: Day 365
Prevalence and intensity of urinary schistosomiasis as a measure of efficacy
Proportion of schoolchildren with urinary schistosomiasis by study arm compared to baseline
Measured: 365 days post first intervention
Prevalence and density of malaria parasites by microscopy as a measure of efficacy
Proportion of schoolchildren with malaria parasitemia by study arm compared to baseline
Measured: 365 days
Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy
Proportion of schoolchildren with intestinal schistosomiasis by study arm compared to baseline
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2011 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navrongo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- DBL -Institute for Health Research and Development
- Responsible party
- Principal investigator, Dr. Ernest Cudjoe Opoku M.D., M.P.H., Navrongo Health Research Centre, Ghana
- Investigators
- Ernest C Opoku, MD, MPH, Principal investigator, Navrongo Health Research Centre, GhanaPascal Magnussen, MD, Principal investigator, University of CopenhagenAbraham V Hodgson, MD, MPH, PhD, Study director, Navrongo Health Research Centre, GhanaEdmund L Browne, MD, MPH, PhD, Principal investigator, University of Development StudiesAnnette Olsen, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459146
- Sponsor's protocol ID
- NHRCIRB098
- Acronym
- ACTIPT
- Status last verified
- Oct 2011
- First submitted
- 17 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intermittent Preventive Malaria Treatment With Artemisinin Combination Therapy (ACT) on Hemoglobin, Malaria, Schistosomiasis, and School Attention Among Primary Schoolchildren in the Kassena-Nankana Districts, Ghana
- ClinicalTrials.gov ID
- NCT01459146
- Acronym / sponsor ID
- ACTIPT / NHRCIRB098
- Conditions
- Malaria, Schistosomiasis, Helminthiasis, Anemia, Change in Sustained Attention
- Keywords
- IPT, malaria, ACT, schistosomiasis, Hemoglobin, Anemia, Sustained attention, Recall
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Navrongo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- DBL -Institute for Health Research and Development
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration.
Detailed description
Introduction: Malaria, schistosomiasis and soil-transmitted helminth (STH) infections are rife in sub-Saharan Africa where school children are at great risk of morbidity. Although the strategy of using intermittent preventive treatment (IPT) for malaria control has been proven beneficial among infants and pregnant women, it is yet to be implemented in school children on a large scale. Sulfadoxine-pyrimethamine (SP) use as IPT is being limited by widespread reports of resistance. Artemisinin-based combination therapy (ACT) has been proven efficacious as IPT among school children in few studies. Other studies have shown that artemisinin derivatives exhibit anti-schistosomal activity. This could be an added effect of using ACTs, as IPT, to prevent malaria related morbidity in school children in sub-Saharan Africa.
General Objective: To examine the effect of IPT with ACTs and anti-helminthes against malaria and helminthes infections on health and school attention among children 6 to 12 years old.
Specific objectives
- To estimate the prevalence of malaria parasitemia, schistosomiasis and anemia among primary schoolchildren.
- To determine the impact of 3 doses of IPT (with artemether-lumefantrine) and de-worming (with albendazole and/or praziquantel) on hemoglobin and school (classroom) attention and recall.
- To determine the effects of IPT (with artemether-lumefantrine) and de-worming (with albendazole and /or praziquantel) on the prevalence and intensity of schistosomes infection among schoolchildren.
- To determine the safety and tolerability of IPT with artemether-lumefantrine combined with albendazole and/or praziquantel among school children.
Materials and methods: An open-labeled randomized trial, including 3 arms, will be carried out in 6 primary schools in the Kassena-Nankana Districts, Ghana, where malaria and schistosome infection (with S. hematobium and S. mansoni) are endemic. After informed consent and assent are obtained, about 345 (115 in each arm) class three school children will be investigated for malaria parasitemia, anemia, schistosome and soil-transmitted helminths infections, and classroom attention and recall in a baseline pre-intervention survey. Mass treatment is then carried out in the 6 randomized schools with ACT and albendazole in one study arm; ACT, albendazole and praziquantel in the second arm while albendazole and praziquantel will be given in the third school arm. ACT mass treatment using artemether-lumefantrine is carried out every school term (4 monthly) for one year while praziquantel is given once and albendazole twice a year. After one academic year, the same 345 (115 in each arm) selected participants in class three are assessed for hemoglobin, malaria parasitemia, STH and schistosome infections and classroom attention and recall. Safety and tolerability of the combined IPT is assessed at 28 days post treatment.
Data analysis- Data will be analyzed by both intention-to-treat and per-protocol employing uni-variate and multivariate logistic regression analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AL plus ABZ; Arm 1 | Experimental | Drug: Artemether-lumefantrine combination plus albendazoleArtemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral |
| AL plus PZQ plus ABZ; Arm 2 | Active comparator | Drug: Artemether-lumefantrine plus Praziquantel plus Albendazoleartemether-lumefantrine combination 120mg/20mg 12 hourly for 3 days; plus praziquantel 40mg/kg stat; plus albendazole 400mg stat oral |
| ABZ plus PZQ; Arm 3 | Active comparator | Drug: Albendazole plus PraziquantelAlbendazole 400mg stat plus Praziquantel 40mg/kg stat oral |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parental informed consent and assent by schoolchildren
- No known history of allergy to any study drug
- Aged 6 or more years
Key exclusion criteria (3 listed)
- lack of parental informed consent and assent by schoolchildren
- Known allergy or history of allergy to any study drug
- Aged less than 6 years
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 |
|---|---|---|
| Artemether-lumefantrine combination plus albendazoleAL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat | Drug | AL plus ABZ; Arm 1 |
| Artemether-lumefantrine plus Praziquantel plus AlbendazoleArtemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral | Drug | AL plus PZQ plus ABZ; Arm 2 |
| Albendazole plus PraziquantelAlbendazole 400mg stat plus Praziquantel 40mg/kg stat oral | Drug | ABZ plus PZQ; Arm 3 |
Primary outcome
Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy
Time frame: Day 28 post intervention
Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions
6 secondary outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Day 365
Number of schoolchildren with sustained attention and recall as a measure of efficacy
Time frame: Day 365
Proportion of schoolchildren with anemia as a measure of safety and tolerability
Time frame: Day 365
Prevalence and intensity of urinary schistosomiasis as a measure of efficacy
Time frame: 365 days post first intervention
Prevalence and density of malaria parasites by microscopy as a measure of efficacy
Time frame: 365 days
Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy
Time frame: 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
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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.
Ernest C Opoku, MD, MPH principal investigator
Navrongo Health Research Centre, Ghana
Pascal Magnussen, MD principal investigator
University of Copenhagen
Abraham V Hodgson, MD, MPH, PhD study director
Navrongo Health Research Centre, Ghana
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 Artemether-lumefantrine combination plus albendazole, Artemether-lumefantrine plus Praziquantel plus Albendazole and Albendazole plus Praziquantel in people with Malaria and Schistosomiasis, run by Navrongo Health Research Centre, Ghana at 1 site in Ghana.
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: status not confirmed, as of the sponsor's last update on 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernest C Opoku, MD, MPH (+233 244 734608, erniecudjoe@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy (time frame: Day 28 post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2011.