Trial of Malaria Seasonal IPTc Combined With Community Case Management

This study has been completed.
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Jean Louis Ndiaye, Cheikh Anta Diop University, Senegal
ClinicalTrials.gov Identifier:
NCT01449045
First received: September 11, 2011
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention Phase
Malaria
Drug: IPTc+CCM
Drug: Community Case Management with artemether-lumefantrine (AL)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cluster Randomized Trial of Malaria Seasonal IPTc Combined With Community Case Management in Saraya District, SE Senegal

Resource links provided by NLM:


Further study details as provided by Cheikh Anta Diop University, Senegal:

Primary Outcome Measures:
  • Number of children under 10 years of age with clinical malaria [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Number of children under 10 years of age presenting clinical Malaria with high parasite density [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 4554
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449045

Locations
Senegal
University Cheikh Anta Diop
Dakar, Senegal
Sponsors and Collaborators
Cheikh Anta Diop University, Senegal
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
  More Information

No publications provided

Responsible Party: Jean Louis Ndiaye, Assistant Professor, Cheikh Anta Diop University, Senegal
ClinicalTrials.gov Identifier: NCT01449045     History of Changes
Other Study ID Numbers: SEN11.16, TA.2010.40200.032
Study First Received: September 11, 2011
Last Updated: April 25, 2012
Health Authority: Senegal: Ministere de la sante

Keywords provided by Cheikh Anta Diop University, Senegal:
IPTc
Community Case Management
Home Management for malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Artemether
Sulfadoxine-pyrimethamine
Lumefantrine
Artemether-lumefantrine combination
Artemisinins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on July 20, 2014