Zambia Integrated Management of Malaria and Pneumonia Study (ZIMMAPS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Zambia Integrated Management of Malaria and Pneumonia Study|
- Number of Children Who Received Early and Appropriate Treatment for Pneumonia. [ Time Frame: one year ] [ Designated as safety issue: No ]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
- Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Number of Children Who do Not Respond to Treatment for Pneumonia [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days.
Drug: Coartem and amoxicillin
Perform RDT and give Coartem for malaria and give amoxicillin for fast breathing
Active Comparator: 2
Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility
Give Coartem without RDT and refer fast breathing
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..
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513500
|Chikankata Health Services|
|Chikankata, Southern Province, Zambia|
|Principal Investigator:||Kojo Yeboah-Antwi, MD, MPH||Center for International Health and Development|