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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

Page last updated: August 20, 2015

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