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Completed

NCT Number: NCT02151578

Home Management of Malaria and Pneumonia

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

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Key information

Conditions

Malaria Infections Lung Diseases Mosquito-Borne Diseases Parasitic Diseases Pneumonia Protozoan Infections Respiratory Tract Diseases Respiratory Tract Infections Vector Borne Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Groupe de Recherche Action en Sante (GRAS sarl)

Ouagadougou, Kadiogo, Burkina Faso

About this study

An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • living in one of the study cluster (villages)
  • no story of allergy to any of the study drugs
  • history of fever or body temperature >= 38.5°C

Exclusion criteria

  • signs of severity/complications like impaired consciousness, convulsions, fast breathing etc

Treatment and study plan

home/community case management

Other

Primary outcomes

  1. Number of death in children aged 6 to 59 months

    Time frame: 12 months

    annual crude mortality rate in children aged 0 to 6 months in the different study arms

Secondary outcomes

  1. - specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level

    Time frame: 12 months

Other outcomes

  1. Adverse events at community level consecutive to the administration of the cotrimoxazole and arthemeter/lumefantrine

    Time frame: 7 days after the administration of the drug

Sponsors and collaborators

Lead sponsor

World Health Organization

Other

Registry information

Official study title

Home and Community Management of Fevers/Malaria and Pneumonia in Children Under-five: a Cluster Randomised Controlled Trial of an Integrated Approach in a Rural District of Burkina Faso

Acronym: HMM/P

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 30, 2014
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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