Clinical trial NCT01449045: Trial of Malaria Seasonal IPTc Combined With Community Case Management
Official title: Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: IPTc
Community Case Management
Home Management for malaria
Lead sponsor: Cheikh Anta Diop University, Senegal
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
First posted: 2011-10-07
Enrollment: 4554
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Known allergy to the study investigational drug
* Any underlying chronic or severe condition.
* Participant under Treatment with sulfamides

Primary outcomes:
measure: Number of children under 10 years of age with clinical malaria
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Number of children under 10 years of age presenting clinical Malaria with high parasite density
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Dakar
country: Senegal
facility: University Cheikh Anta Diop
Study officials:
affiliation: Cheikh Anta Diop University, Senegal
name: Oumar Gaye, PhD
role: STUDY_DIRECTOR
affiliation: London School of Hygiene and Tropical Medicine
name: Paul Milligan, PhD
role: STUDY_CHAIR
affiliation: Cheikh Anta Diop University, Senegal
name: Badara Cisse, PhD
role: STUDY_CHAIR
References:
citation: 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.