MalariaPhase 4NCT01651416
Seasonal Malaria Chemoprevention Versus Home Management of Malaria in Children Under 5 Years in Ghana
A Phase 4 study testing Artemether-lumefantrine combination, Dihydroartemisinin Piperaquine combination and Amodiaquine plus sulphadoxine-pyrimethamine combination in people with Malaria and Anaemia, run by Centre for Global Health Research, Ghana at 1 site in Ghana.
Trial summary
In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. Read more about this study
- Who is it for?
- Ages 3 to 59 months
- What is being tested?
- Artemether-lumefantrine combination, Dihydroartemisinin Piperaquine combination and Amodiaquine plus sulphadoxine-pyrimethamine combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteGhana
- Study dates
- Jul 2012to Jul 2013
- 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 3 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged between 3-59 months
- Care giver or parent willing to participate and have given informed consent
- Children living in the study area
Who cannot join
- Children who are unable to take and retain medication
- Children who have a severe or chronic illness
- Children who have a history of serious adverse reaction to the study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.
In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.
Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.
The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.
- Being tested
- Artemether-lumefantrine combination, Dihydroartemisinin Piperaquine combination, Amodiaquine plus sulphadoxine-pyrimethamine combination
- Keywords
- Home management of malaria, Seasonal malaria chemoprevention
- Medical subject headings
- Malaria, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-lumefantrine combinationDrug
Dihydroartemisinin Piperaquine combinationDrug
Also called Duo-cotecxin
Amodiaquine plus sulphadoxine-pyrimethamine combinationDrug
| Study group | Role | What they receive |
|---|---|---|
| HMM using short-acting ACT | Active comparator | Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs Receives: Drug: Artemether-lumefantrine combination |
| HMM using short-acting ACT plus SMC | Experimental | Home management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination. Receives: Drug: Artemether-lumefantrine combination; Drug: Amodiaquine plus sulphadoxine-pyrimethamine combination |
| HMM using a long-acting ACT | Experimental | Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs Receives: Drug: Dihydroartemisinin Piperaquine combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malaria cases
Incidence of malaria cases recorded by the community health workers (CHWs) and at the study health centres. Malaria will be defined as fever or history of fever combined with parasitologically confirmed P. falciparum infection by blood slide. Management of suspected malaria cases reporting to CHWs and health centres will be according to rapid diagnostic test (RDT).
Measured: 12 months
Secondary outcomes (5)
Proportion of children with parasitaemia
Parasitaemia detected by rapid diagnostic test (RDT) and parasitologically confirmation of P. falciparum infection by blood slide..
Measured: 12 months
Proportion of children with anaemia
Anaemia is defined as haemoglobin less than <8 g/dL
Measured: 12 months
Number of referrals
Referrals to hospital and admissions due to malaria and other causes
Measured: 12 months
Incidence of severe illness
Measured: 12 months
Incidence of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionJul 2013
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Global Health Research, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Harry Tagbor, Centre for Global Health Research, Ghana
- Investigators
- Harry Tagbor, DrPH, Principal investigator, Kwame Nkrumah University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651416
- Sponsor's protocol ID
- QA389
- Status last verified
- Sep 2015
- First submitted
- 25 Jul 2012
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.
- ClinicalTrials.gov ID
- NCT01651416
- Acronym / sponsor ID
- QA389
- Keywords
- Home management of malaria, Seasonal malaria chemoprevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Centre for Global Health Research, GhanaUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Jul 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.
In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.
Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.
The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HMM using short-acting ACT | Active comparator | Drug: Artemether-lumefantrine combinationHome management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs |
| HMM using short-acting ACT plus SMC | Experimental | Drug: Artemether-lumefantrine combination, Drug: Amodiaquine plus sulphadoxine-pyrimethamine combinationHome management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination. |
| HMM using a long-acting ACT | Experimental | Drug: Dihydroartemisinin Piperaquine combinationHome management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged between 3-59 months
- Care giver or parent willing to participate and have given informed consent
- Children living in the study area
Key exclusion criteria (3 listed)
- Children who are unable to take and retain medication
- Children who have a severe or chronic illness
- Children who have a history of serious adverse reaction to the study drugs
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 | Drug | HMM using short-acting ACT, HMM using short-acting ACT plus SMC |
| Dihydroartemisinin Piperaquine combinationAlso: Duo-cotecxin | Drug | HMM using a long-acting ACT |
| Amodiaquine plus sulphadoxine-pyrimethamine combination | Drug | HMM using short-acting ACT plus SMC |
Primary outcome
Incidence of malaria cases
Time frame: 12 months
Incidence of malaria cases recorded by the community health workers (CHWs) and at the study health centres. Malaria will be defined as fever or history of fever combined with parasitologically confirmed P. falciparum infection by blood slide. Management of suspected malaria cases reporting to CHWs and health centres will be according to rapid diagnostic test (RDT).
5 secondary outcomes
Proportion of children with parasitaemia
Time frame: 12 months
Proportion of children with anaemia
Time frame: 12 months
Number of referrals
Time frame: 12 months
Incidence of severe illness
Time frame: 12 months
Incidence of adverse events
Time frame: 12 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 18 Sep 2015.
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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.
Harry Tagbor, DrPH principal investigator
Kwame Nkrumah University of Science and Technology
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, Dihydroartemisinin Piperaquine combination and Amodiaquine plus sulphadoxine-pyrimethamine combination in people with Malaria and Anaemia, run by Centre for Global Health Research, 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: finished, as of the sponsor's last update on 18 Sep 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 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?
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 malaria cases (time frame: 12 months). 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 18 Sep 2015.