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Sponsors and Collaborators: |
Boston University Center for International Health and Development United States Agency for International Development (USAID) |
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Information provided by: | Boston University |
ClinicalTrials.gov Identifier: | NCT00513500 |
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.
Condition | Intervention |
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Community Health Care |
Drug: Coartem and amoxicillin Drug: Coartem |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Zambia Integrated Management of Malaria and Pneumonia Study |
Estimated Enrollment: | 2931 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | November 2009 |
Arms | Assigned Interventions |
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1: Experimental
Give treatment normally given at rural health center
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Drug: Coartem and amoxicillin
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
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2: Active Comparator
Give community health post treatment
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Drug: Coartem
Give Coartem without RDT and refer fast breathing
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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..
Ages Eligible for Study: | 6 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kojo Yeboah-Antwi, MD, MPH | 617-414-1275 | kyantwi@bu.edu |
Contact: Davidson Hamer, MD | 617-414-1267 | dhamer@bu.edu |
Zambia, Southern Province | |
Chikankata Health Services | |
Chikankata, Southern Province, Zambia |
Principal Investigator: | Kojo Yeboah-Antwi, MD, MPH | Center for International Health and Development |
Study ID Numbers: | GHS-A-00-00020-00-5 |
Study First Received: | August 7, 2007 |
Last Updated: | August 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00513500 |
Health Authority: | United States: Institutional Review Board; Zambia: Research Ethics Committee |
community health worker malaria pneumonia rapid diagnostic test |
Benflumetol Artemether-lumefantrine combination Protozoan Infections Amoxicillin Respiratory Tract Infections Respiratory Tract Diseases |
Lung Diseases Parasitic Diseases Malaria Pneumonia Artemether |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents |
Antiprotozoal Agents Coccidiosis Therapeutic Uses Pharmacologic Actions |