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Completed

NCT Number: NCT00513500

Zambia Integrated Management of Malaria and Pneumonia Study

The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chikankata Health Services

Chikankata, Southern Province, Zambia

About this study

Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities.

Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 6 months and 5 years
  • Present with history of fever or reported fever
  • Present with cough or difficult breathing

Exclusion criteria

  • Age below 6 months and above 5 years
  • Presence of signs and symptoms of severe illness

Treatment and study plan

Coartem and amoxicillin

Drug

Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing

Coartem

Drug

Give Coartem without RDT and refer fast breathing

Primary outcomes

  1. Number of Children Who Received Early and Appropriate Treatment for Pneumonia.

    Time frame: one year

    Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom

  2. Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)

    Time frame: one year

Secondary outcomes

  1. Number of Children Who do Not Respond to Treatment for Pneumonia

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Center for International Health and Development
  • United States Agency for International Development (USAID)

Registry information

Acronym: ZIMMAPS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2007
Registry last updated
Jul 20, 2010

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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