MalariaPhase 3NCT01449045
Trial of Malaria Seasonal IPTc Combined With Community Case Management
A Phase 3 study testing IPTc+CCM and Community Case Management with artemether-lumefantrine (AL) in people with Malaria, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
Trial summary
Malaria is a major public health problem. 250 million cases annually leads to approximately 1 million deaths. Over 80 per cent of these deaths occur among African children under age five. Read more about this study
- Who is it for?
- Ages 3 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- IPTc+CCM and Community Case Management with artemether-lumefantrine (AL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,554 participants
- Where
- 1 siteSenegal
- Study dates
- Jul 2011to Feb 2012
- Phase
- Phase 3
- 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 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between 3 to 120 months
- consent participation given by parents or guardians
- willing to remain in the study area in the next 6 months
Who cannot join
- Known allergy to the study investigational drug
- Any underlying chronic or severe condition.
- Participant under Treatment with sulfamides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal
Malaria is a major public health problem. 250 million cases annually leads to approximately 1 million deaths. Over 80 per cent of these deaths occur among African children under age five. The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis. This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009. However the recent overall decline hides the fact that malaria incidence remains very high in the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a therapeutic dose of antimalarials can achieve a very high degree of protection from attacks of clinical malaria in children. The purpose of this project is to evaluate the effectiveness of combining IPTc with HMM in southern Senegal
The study objectives are to :
- Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in areas with a longer transmission season,
- Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine + Amodiaquine can offer in populations where a rapid and early care with home management of malaria is already established.
- Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in villages where home-based management of malaria is implemented. All villages in Saraya district, excluding 7 villages with a health post, will be eligible to participate. Saraya villages will be combined to form 24 clusters which will be randomized to receive HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of clinical malaria with fever or history of fever and parasitaemia with density of at least 3000/ul. Secondary outcomes will include the safety, the tolerability, the coverage and acceptability of the intervention. Both the recurrent and capital costs to the health service of training staff and delivering the interventions will be estimated. Both direct and indirect costs to users of the services (children and their families) will also be assessed.
- Conditions
- Malaria
- Being tested
- IPTc+CCM, Community Case Management with artemether-lumefantrine (AL)
- Keywords
- IPTc, Community Case Management, Home Management for malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPTc+CCMDrug
Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management
Community Case Management with artemether-lumefantrine (AL)Drug
Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive
| Study group | Role | What they receive |
|---|---|---|
| Community Case Management | Placebo comparator | Provision of access to prompt diagnosis and treatment for malaria by community volunteers in the village (PECADOM) Receives: Drug: Community Case Management with artemether-lumefantrine (AL) |
| Community Case Management plus IPTc | Experimental | Monthly Intermittent Preventive Treatment with sulfadoxine pyrimethamine plus amodiaquine, in addition to community case management Receives: Drug: IPTc+CCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children under 10 years of age with clinical malaria
children under 10 years age presenting symptoms of malaria with fever (or history of fever in the previous 48 hours) with a positive Rapid Diagnostic Test or positive blood slides
Measured: up to 24 weeks
Secondary outcomes (1)
Number of children under 10 years of age presenting clinical Malaria with high parasite density
Malaria with parasite density at 3000 parasites/uL or more in the presence of fever or history of fever in the previous 48hours in children under 10 years of age
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionFeb 2012
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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheikh Anta Diop University, Senegal
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal
- Investigators
- Oumar Gaye, PhD, Study director, Cheikh Anta Diop University, SenegalPaul Milligan, PhD, Study chair, London School of Hygiene and Tropical MedicineBadara Cisse, PhD, Study chair, Cheikh Anta Diop University, Senegal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449045
- Sponsor's protocol ID
- SEN11.16
- Other IDs
- TA.2010.40200.032
- Status last verified
- Apr 2012
- First submitted
- 11 Sep 2011
- Last updated
- 26 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ndiaye JLA, Ndiaye Y, Ba MS, Faye B, Ndiaye M, Seck A, Tine R, Thior PM, Atwal S, Beshir K, Sutherland C, Gaye O, Milligan P. Seasonal malaria chemoprevention combined with community case management of malaria in children under 10 years of age, over 5 months, in south-east Senegal: A cluster-randomised trial. PLoS Med. 2019 Mar 13;16(3):e1002762. doi: 10.1371/journal.pmed.1002762. eCollection 2019 Mar.
PubMed 30865632
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal
- ClinicalTrials.gov ID
- NCT01449045
- Acronym / sponsor ID
- SEN11.16
- Conditions
- Malaria
- Keywords
- IPTc, Community Case Management, Home Management for malaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,554 participants (actual)
- Lead sponsor
- Cheikh Anta Diop University, SenegalUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 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.
Malaria is a major public health problem. 250 million cases annually leads to approximately 1 million deaths. Over 80 per cent of these deaths occur among African children under age five. The main interventions covered treatment with Artemisinin Combination Therapies (ACT), long lasting bednets distribution and Rapid Diagnosis Tests (RDT) to improve malaria diagnosis. This has led in Senegal to a substantial decrease in the incidence of malaria, in 2009. However the recent overall decline hides the fact that malaria incidence remains very high in the south of Senegal. That's why Home-based management (HMM) for malaria is being introduced in selected areas. Intermittent Preventive Treatment (IPT) by monthly administration of a therapeutic dose of antimalarials can achieve a very high degree of protection from attacks of clinical malaria in children. The purpose of this project is to evaluate the effectiveness of combining IPTc with HMM in southern Senegal
The study objectives are to :
- Assess the tolerance of IPTc using SP+AQ when it is administered for a longer period in areas with a longer transmission season,
- Assess the added benefit that IPT with the association of Sulfadoxine-Pyrimethamine + Amodiaquine can offer in populations where a rapid and early care with home management of malaria is already established.
- Determine the cost benefit ratio of the addition of IPTc with HMM. A cluster randomized controlled trial has been designed to evaluate the effectiveness of adding seasonal IPTc with sulfadoxine-pyrimethamine plus amodiaquine (SP+AQ) for 5 months per year, in villages where home-based management of malaria is implemented. All villages in Saraya district, excluding 7 villages with a health post, will be eligible to participate. Saraya villages will be combined to form 24 clusters which will be randomized to receive HMM from a community volunteer, or IPTc plus HMM. Trained volunteer Community Medicine Distributors (CMD) will provide HMM. The primary endpoint will be the incidence of clinical malaria with fever or history of fever and parasitaemia with density of at least 3000/ul. Secondary outcomes will include the safety, the tolerability, the coverage and acceptability of the intervention. Both the recurrent and capital costs to the health service of training staff and delivering the interventions will be estimated. Both direct and indirect costs to users of the services (children and their families) will also be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Case Management | Placebo comparator | Drug: Community Case Management with artemether-lumefantrine (AL)Provision of access to prompt diagnosis and treatment for malaria by community volunteers in the village (PECADOM) |
| Community Case Management plus IPTc | Experimental | Drug: IPTc+CCMMonthly Intermittent Preventive Treatment with sulfadoxine pyrimethamine plus amodiaquine, in addition to community case management |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 3 to 120 months
- consent participation given by parents or guardians
- willing to remain in the study area in the next 6 months
Key exclusion criteria (3 listed)
- Known allergy to the study investigational drug
- Any underlying chronic or severe condition.
- Participant under Treatment with sulfamides
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 |
|---|---|---|
| IPTc+CCMMonthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management | Drug | Community Case Management plus IPTc |
| Community Case Management with artemether-lumefantrine (AL)Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive | Drug | Community Case Management |
Primary outcome
Number of children under 10 years of age with clinical malaria
Time frame: up to 24 weeks
children under 10 years age presenting symptoms of malaria with fever (or history of fever in the previous 48 hours) with a positive Rapid Diagnostic Test or positive blood slides
1 secondary outcome
Number of children under 10 years of age presenting clinical Malaria with high parasite density
Time frame: up to 24 weeks
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 26 Apr 2012.
- Derived from this study: PubMed 30865632Ndiaye JLA, Ndiaye Y, Ba MS, Faye B, Ndiaye M, Seck A, Tine R, Thior PM, Atwal S, Beshir K, Sutherland C, Gaye O, Milligan P. Seasonal malaria chemoprevention combined with community case management of malaria in children under 10 years of age, over 5 months, in south-east Senegal: A cluster-randomised trial. PLoS Med. 2019 Mar 13;16(3):e1002762. doi: 10.1371/journal.pmed.1002762. eCollection 2019 Mar.
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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.
Oumar Gaye, PhD study director
Cheikh Anta Diop University, Senegal
Paul Milligan, PhD study chair
London School of Hygiene and Tropical Medicine
Badara Cisse, PhD study chair
Cheikh Anta Diop University, Senegal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IPTc+CCM and Community Case Management with artemether-lumefantrine (AL) in people with Malaria, run by Cheikh Anta Diop University, Senegal at 1 site in Senegal.
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 26 Apr 2012. 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 Senegal. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of children under 10 years of age with clinical malaria (time frame: up to 24 weeks). 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 NCT01449045, 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 26 Apr 2012.