Zambia Integrated Management of Malaria and Pneumonia Study
Information source: Boston University
Information obtained from ClinicalTrials.gov on October 19, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Health Care
Intervention: Coartem and amoxicillin (Drug); Coartem (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Boston University Official(s) and/or principal investigator(s): Kojo Yeboah-Antwi, MD, MPH, Principal Investigator, Affiliation: Center for International Health and Development
Overall contact: Kojo Yeboah-Antwi, MD, MPH, Phone: 617-414-1275, Email: kyantwi@bu.edu
Summary
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.
Clinical Details
Official title: Zambia Integrated Management of Malaria and Pneumonia Study
Study design: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Measure proportion of children who receive early and appropriate treatment for pneumoniaDetermine the extent to which the use of RDTs by CHWs reduces the use of Coartem in managing children with acute fever
Secondary outcome: Measure proportion of children who do not respond to treatmentMeasure the cost-effectiveness of CHWs managing malaria using Coartem with RDTs
Detailed description:
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..
Eligibility
Minimum age: 6 Months.
Maximum age: 5 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Kojo Yeboah-Antwi, MD, MPH, Phone: 617-414-1275, Email: kyantwi@bu.edu
Chikankata Health Services, Chikankata, Southern Province, Zambia
Additional Information
Starting date: September 2007
Ending date: November 2009
Last updated: August 8, 2007
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