Trial of Malaria Seasonal IPTc Combined With Community Case Management

NCT01449045 | Completed Phase 3 DMC

• 2 other identifiers: SEN11.16TA.2010.40200.032
• Study Type: interventional
• Target: 4,554
• Locations: 1 country
• Sites: 1

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

Keywords

IPTc; Community Case Management; Home Management for malaria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of children under 10 years of age presenting clinical Malaria with high parasite density

  up to 24 weeks

Study Arms (2)

Community Case Management

PLACEBO COMPARATOR

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)

Community Case Management plus IPTc

EXPERIMENTAL

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

Drug: IPTc+CCM

Interventions

IPTc+CCM DRUG

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

Community Case Management plus IPTc

Community Case Management with artemether-lumefantrine (AL) DRUG

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

Community Case Management

Eligibility Criteria

• Age: 3 Months - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cheikh Anta Diop University, Senegal: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

University Cheikh Anta Diop

Dakar, Senegal

Location

Related Publications (1)

• 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.

  PMID: 30865632 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Oumar Gaye, PhD

  Cheikh Anta Diop University, Senegal

  STUDY DIRECTOR

• Paul Milligan, PhD

  London School of Hygiene and Tropical Medicine

  STUDY CHAIR

• Badara Cisse, PhD

  Cheikh Anta Diop University, Senegal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2011
• First Posted: October 7, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: April 26, 2012

Record last verified: 2012-04

Locations

SE (1)