Zambia Integrated Management of Malaria and Pneumonia Study
Information source: Boston University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia; Malaria
Intervention: Coartem and amoxicillin (Drug); Coartem (Drug)
Phase: N/A
Status: Completed
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
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Primary outcome: Number of Children Who Received Early and Appropriate Treatment for Pneumonia.Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
Secondary outcome: Number of Children Who do Not Respond to Treatment for Pneumonia
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
Chikankata Health Services, Chikankata, Southern Province, Zambia
Additional Information
Starting date: June 2007
Last updated: July 13, 2010
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