Zambia Integrated Management of Malaria and Pneumonia Study

Not Applicable

Completed

Conditions: Pneumonia
Malaria

Interventions: Drug: Coartem and amoxicillin
Drug: Coartem

Registration Number: NCT00513500

Lead Sponsor: Boston University

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..

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3125

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Coartem and amoxicillin	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.
2	Coartem	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

Primary Outcome Measures

Name	Time	Method
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.	one year	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)	one year

Secondary Outcome Measures