Clinical Trials Directory

Trials / Completed

CompletedNCT00513500

Zambia Integrated Management of Malaria and Pneumonia Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3,125 (actual)
Sponsor
Boston University · Academic / Other
Sex
All
Age
6 Months – 5 Years
Healthy volunteers
Not accepted

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..

Conditions

Interventions

TypeNameDescription
DRUGCoartem and amoxicillinPerform RDT and give Coartem for malaria and give amoxicillin for fast breathing
DRUGCoartemGive Coartem without RDT and refer fast breathing

Timeline

Start date
2007-06-01
Primary completion
2009-02-01
Completion
2009-09-01
First posted
2007-08-08
Last updated
2010-07-20
Results posted
2010-07-13

Locations

1 site across 1 country: Zambia

Source: ClinicalTrials.gov record NCT00513500. Inclusion in this directory is not an endorsement.