Trial of Malaria Seasonal IPTc Combined With Community Case Management

April 25, 2012 updated by: Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4554

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Senegal
      • Dakar, Senegal
        • University Cheikh Anta Diop

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Community Case Management
Provision of access to prompt diagnosis and treatment for malaria by community volunteers in the village (PECADOM)
Drug: Community Case Management with artemether-lumefantrine (AL)
Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive
Experimental: Community Case Management plus IPTc
Monthly Intermittent Preventive Treatment with sulfadoxine pyrimethamine plus amodiaquine, in addition to community case management
Drug: IPTc+CCM
Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of children under 10 years of age presenting clinical Malaria with high parasite density
Time Frame: up to 24 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheikh Anta Diop University, Senegal

Collaborators

London School of Hygiene and Tropical Medicine

Investigators

  • Study Director: Oumar Gaye, PhD, Cheikh Anta Diop University, Senegal
  • Study Chair: Paul Milligan, PhD, London School of Hygiene and Tropical Medicine
  • Study Chair: Badara Cisse, PhD, Cheikh Anta Diop University, Senegal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 11, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEN11.16
  • TA.2010.40200.032 (Other Grant/Funding Number: EDCTP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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