Clinical trial NCT00513500: Zambia Integrated Management of Malaria and Pneumonia Study
Official title: Zambia Integrated Management of Malaria and Pneumonia Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Malaria
Keywords: community health care
community health worker
malaria
pneumonia
rapid diagnostic test
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Center for International Health and Development
name: United States Agency for International Development (USAID)
First posted: 2007-08-08
Enrollment: 3125
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Number of Children Who Received Early and Appropriate Treatment for Pneumonia.
timeFrame: one year
measure: Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)
timeFrame: one year
Secondary outcomes:
measure: Number of Children Who do Not Respond to Treatment for Pneumonia
timeFrame: one year
Other outcomes:
Locations:
city: Chikankata
country: Zambia
facility: Chikankata Health Services
state: Southern Province
Study officials:
affiliation: Center for International Health and Development
name: Kojo Yeboah-Antwi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yeboah-Antwi K, Pilingana P, Macleod WB, Semrau K, Siazeele K, Kalesha P, Hamainza B, Seidenberg P, Mazimba A, Sabin L, Kamholz K, Thea DM, Hamer DH. Community case management of fever due to malaria and pneumonia in children under five in Zambia: a cluster randomized controlled trial. PLoS Med. 2010 Sep 21;7(9):e1000340. doi: 10.1371/journal.pmed.1000340.