Trial of Malaria Seasonal IPTc Combined With Community Case Management

NCT ID: NCT01449045

Last Updated: 2012-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 4554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-02-29

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Community Case Management

Provision of access to prompt diagnosis and treatment for malaria by community volunteers in the village (PECADOM)

Group Type: PLACEBO_COMPARATOR

Community Case Management with artemether-lumefantrine (AL)

Intervention Type: DRUG

Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive

Community Case Management plus IPTc

Monthly Intermittent Preventive Treatment with sulfadoxine pyrimethamine plus amodiaquine, in addition to community case management

Group Type: EXPERIMENTAL

IPTc+CCM

Intervention Type: DRUG

Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management

Interventions

IPTc+CCM

Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management

Intervention Type: DRUG

Community Case Management with artemether-lumefantrine (AL)

Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role: lead

Responsible Party

Jean Louis Ndiaye

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oumar Gaye, PhD

Role: STUDY_DIRECTOR

Cheikh Anta Diop University, Senegal

Paul Milligan, PhD

Role: STUDY_CHAIR

London School of Hygiene and Tropical Medicine

Badara Cisse, PhD

Role: STUDY_CHAIR

Cheikh Anta Diop University, Senegal

Locations

University Cheikh Anta Diop

Dakar, , Senegal

Countries

Senegal

References

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.

Reference Type: DERIVED

PMID: 30865632 (View on PubMed)

Other Identifiers

TA.2010.40200.032

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SEN11.16

Identifier Type: -

Identifier Source: org_study_id