Trial of Malaria Seasonal IPTc Combined With Community Case Management

Malaria Clinical Trial

Official title:

Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449045
• Other study ID #: SEN11.16
• Secondary ID: TA.2010.40200.03
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2011
• Last updated: April 25, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2012
• Source: Cheikh Anta Diop University, Senegal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4554
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• IPTc+CCM
Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management
• Community Case Management with artemether-lumefantrine (AL)
Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive

Locations

Country	Name	City	State
Senegal	University Cheikh Anta Diop	Dakar

Sponsors (2)

Lead Sponsor	Collaborator
Cheikh Anta Diop University, Senegal	London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 24 weeks	No
Secondary	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	up to 24 weeks	No