MalariaPhase 4KNUST-COMDISNCT00550160
The Synergistic Effects of Home-management and Intermittent Preventive Treatment of Malaria in Children
A Phase 4 study testing Amodiaquine plus Artesunate co-administration in people with Malaria, run by Kwame Nkrumah University of Science and Technology at 1 site in Ghana.
Trial summary
This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Amodiaquine plus Artesunate co-administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,490 participants
- Where
- 1 siteGhana
- Study dates
- Apr 2007to Oct 2008
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- A child in the study cohort will be eligible to receive a course of IPTc (active or placebo) if the child has NO fever (a temperature of 37•5o C or above) or history of fever in the last 24 hours. However, fever is only a temporary exclusion criterion. If a child has fever when he/she is due for an IPTc course, treatment will be given for the fever and the IPTc course given one month after the fever has subsided. This interval between treatment of fever episodes and administration of an IPTc course is proposed in order to minimise the risk of overdosing since the same drug is used for both HMM and IPTc.
Who cannot join
- A child in the study cohort will not be eligible to receive a course of IPTc if:
- The child has a clinical condition that may be classified as severe according to IMCI guidelines.
- The child is known to suffer from chronic disease(s) e.g. sickle cell disease that might adversely affect the interpretation of study results.
- The mother/caregiver withdraws consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Impact of Seasonal Intermittent Preventive Treatment (IPT) and Home Management of Malaria (HMM) Using AQ+AS in Ghanaian Children Under 5 Years of Age - a Cluster Randomised Placebo Controlled Trial.
This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.
The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.
- Conditions
- Malaria
- Being tested
- Amodiaquine plus Artesunate co-administration
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amodiaquine plus Artesunate co-administrationDrug
Under the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The Home Management of Malaria (HMM) is a strategy aimed at improving access to prompt and effective antimalarial treatment of all fevers in children under 5 years. Community Drug Distributors (CDD) have been trained and equipped for this task. Receives: Drug: Amodiaquine plus Artesunate co-administration |
| 2 | Experimental | An Intermittent Preventive Treatment (IPTc) schedule for asymptomatic pre-school children during high malaria transmission seasons alongside an ongoing Home Management of Malaria programme Receives: Drug: Amodiaquine plus Artesunate co-administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of clinical episodes of malaria per child per year
Measured: One year
Secondary outcomes (5)
Prevalence of peripheral parasitaemia
Measured: One year
Prevalence of anaemia
Measured: One year
Parasite density (geometric means)
Measured: One year
Proportions adhering to strategies
Measured: One year
Incidence of adverse drug effects within 7 days after intervention
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionOct 2008
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwame Nkrumah University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Department for International Development, United Kingdom, Malaria Consortium, UK, Center for International Health and Development
- Responsible party
- Principal investigator, Dr. Harry Tagbor, Kwame Nkrumah University of Science and Technology
- Investigators
- Harry Tagbor, DrPH, Principal investigator, Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science & TechnologyEdmund Browne, PhD, Principal investigator, Department of Community Health, School of Medical Sciences, Kwame Nkrumah University of Science & TechnologyHelen Counihan, PhD, Principal investigator, Malaria Consortium, UKSylvia Meek, PhD, Principal investigator, Malaria Consortium, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550160
- Sponsor's protocol ID
- CKNT_1
- Acronym
- KNUST-COMDIS
- Status last verified
- Sep 2015
- First submitted
- 25 Oct 2007
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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
- The Clinical Impact of Seasonal Intermittent Preventive Treatment (IPT) and Home Management of Malaria (HMM) Using AQ+AS in Ghanaian Children Under 5 Years of Age - a Cluster Randomised Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT00550160
- Acronym / sponsor ID
- KNUST-COMDIS / CKNT_1
- Conditions
- Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- Kwame Nkrumah University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Department for International Development, United Kingdom, Malaria Consortium, UK, Center for International Health and Development
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Oct 2007 (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.
This cluster randomised trial is proposed to assess the clinical impact of adding a seasonal intermittent preventive treatment (IPTc) schedule for children aged 3 -59 months to a home management of malaria (HMM) programme using AQ+AS in Ghana. The study will be conducted in the Kwaso sub district of the Ejisu-Juaben district of Ghana in which 6 communities will be randomised to implement an IPTc schedule alongside the HMM programme or HMM programme alone.
The study will run in three phases; a preparatory phase to set up and obtain baseline morbidity data from a cross-sectional survey; an intervention phase and a post intervention phase of cross-sectional survey and data evaluation and dissemination. A cohort of 546 study children randomly selected will receive three full treatment courses of AS+AQ intermittently during the April - Nov 2007 transmission season. Community-based drug distributors (CDDs) will administer all courses of IPTc. The first dose of each course will be directly observed by the CDDs who will educate mothers or caregivers to administer subsequent doses appropriately at home. Follow up visits to homes will be done by CDDs and field supervisors to ascertain adherence and to monitor adverse drug events. The incidence of clinical malaria and other secondary outcomes will be compared with those of another cohort of 546 study children who will not receive IPTc but may be treated under the HMM strategy alone with AS+AQ when necessary during the observation period.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Amodiaquine plus Artesunate co-administrationThe Home Management of Malaria (HMM) is a strategy aimed at improving access to prompt and effective antimalarial treatment of all fevers in children under 5 years. Community Drug Distributors (CDD) have been trained and equipped for this task. |
| 2 | Experimental | Drug: Amodiaquine plus Artesunate co-administrationAn Intermittent Preventive Treatment (IPTc) schedule for asymptomatic pre-school children during high malaria transmission seasons alongside an ongoing Home Management of Malaria programme |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- A child in the study cohort will be eligible to receive a course of IPTc (active or placebo) if the child has NO fever (a temperature of 37•5o C or above) or history of fever in the last 24 hours. However, fever is only a temporary exclusion criterion. If a child has fever when he/she is due for an IPTc course, treatment will be given for the fever and the IPTc course given one month after the fever has subsided. This interval between treatment of fever episodes and administration of an IPTc course is proposed in order to minimise the risk of overdosing since the same drug is used for both HMM and IPTc.
Key exclusion criteria (4 listed)
- A child in the study cohort will not be eligible to receive a course of IPTc if:
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 |
|---|---|---|
| Amodiaquine plus Artesunate co-administrationUnder the Home Management of Malaria (HMM) strategy the Community Drug Distributors (CDD) will treat all children under 5 years presented to them with measured fever or a history of fever with AQ plus AS co-administered. Children under 12 months receive 75mg of AQ co-administered with 25mg of AS daily for three days. Children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days. Asymptomatic children under 5 years in the Intermittent Preventive Treatment (IPTc) clusters will receive additional AQ plus AS co-administered during high malaria transmission season. Those under 12 months will receive 75mg of AQ co-administered with 25mg of AS daily for three days; and children who are 12 to 59 months old receive 150mg of AQ and 50mg of AS co-administered daily for three days. | Drug | 1, 2 |
Primary outcome
Incidence rate of clinical episodes of malaria per child per year
Time frame: One year
5 secondary outcomes
Prevalence of peripheral parasitaemia
Time frame: One year
Prevalence of anaemia
Time frame: One year
Parasite density (geometric means)
Time frame: One year
Proportions adhering to strategies
Time frame: One year
Incidence of adverse drug effects within 7 days after intervention
Time frame: One year
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
Department of Community Health, School of Medical Science, Kwame Nkrumah University of Science & Technology
Edmund Browne, PhD principal investigator
Department of Community Health, School of Medical Sciences, Kwame Nkrumah University of Science & Technology
Helen Counihan, PhD principal investigator
Malaria Consortium, UK
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 Amodiaquine plus Artesunate co-administration in people with Malaria, run by Kwame Nkrumah University of Science and Technology 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 1 inclusion and 4 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 rate of clinical episodes of malaria per child per year (time frame: One year). 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.